Last updated on April 2017

Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (ORBIT-AF II)


Brief description of study

The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF II) is a multicenter, prospective outpatient disease registry to evaluate the utilization of target-specific antithrombotic agents, such as FXa (factor Xa) inhibitors and direct thrombin inhibitors, and associated outcomes. Importantly, the ORBIT AF II registry will permit the collection and analysis of post-approval observational data needed for evaluating the outcomes associated with these new agents when used in broader patient populations outside of clinical studies. The ORBIT-AF II registry will focus on patients with newly diagnosed atrial fibrillation (AF) as well as those who have been recently started on a target-specific oral anticoagulant agent. Taken together, the ORBIT-AF I and ORBIT-AF II registries will offer a broad and contemporary view of AF therapy.

Detailed Study Description

The registry will be used to evaluate, describe, and document the safety of target-specific anticoagulant agents (and other antithrombotic agents) in patients with Atrial Fibrillation (AF), the clinical outcomes associated with their use, the treatment patterns and clinical course of patients with AF, including those who undergo cardiac procedures of interest (ablation, cardioversion, catheterization and surgery, for examples), and characteristics of patients with new onset/first-detected AF. Additionally, the registry will be used to summarize patterns of switching or discontinuation of antithrombotic agents in the United States. The registry will be a nationwide collaboration of health care providers (eg, cardiologists, internists, primary care physicians, electrophysiologists, quality improvement personnel, office/practice managers, research coordinators, and pharmacists). Target enrollment will be approximately 15,000 patients. It is anticipated that enrollment will complete in approximately 3.5 years. Consecutive patients who meet the eligibility criteria will be approached and educated about the registry. Patients who express interest will provide informed consent. Patients enrolled in the registry will be followed for up to 2 years. New patients enrolled in the registry will be followed for up to 1 year. Patient follow-up by their AF care provider will continue as scheduled according to local clinical practice. Data collection will occur at 6 month intervals for approximately 1 year from the time of enrollment of the patient (baseline, 6, and 12 months). Data capture will include demographics, medical history, cardiovascular history, vital signs, echocardiographic and laboratory data, AF status and type (paroxysmal, persistent, long-standing persistent/permanent), pharmacotherapy, contraindications to oral anticoagulant therapy, and provider specialty. Clinical outcomes and safety data capture will include major adverse cardiac events (MACEs).

Clinical Study Identifier: NCT01701817

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Cullman Clinical Research, LLC

Cullman Clinical Research, LLC
Cullman, AL United States
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Eastern Shore Heart Center

Eastern Shore Heart Center
Fairhope, AL United States
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Mobile Heart Specialists, PC

Mobile Heart Specialists, PC
Mobile, AL United States
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Black Warrior Research

Black Warrior Research
Tuscaloosa, AL United States
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IMS Cardiology

IMS Cardiology
Avondale, AZ United States
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Paseo Family Physicians

Paseo Family Physicians
Glendale, AZ United States
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Multispecialty Physicians Internal Medicine-CRI Goodyear

Multispecialty Physicians Internal Medicine-CRI Goodyear
Goodyear, AZ United States
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Scottsdale Healthcare

Scottsdale Healthcare
Scottsdale, AZ United States
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Sun Cit, AZ United States
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Orange Grove Family Practice Clinical Research Advantage, Inc.
Tucson, AZ United States
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Long Life Cardiac Center

Long Life Cardiac Center
Alhambra, CA United States
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Cardiology Consultants of Orange County

Cardiology Consultants of Orange County
Anaheim, CA United States
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Comprehensive Cardiovascular Medical Group_Bakersfield

Comprehensive Cardiovascular Medical Group_Bakersfield
Bakersfield, CA United States
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Beaver Medical Group/ Care Clinical ...

Beaver Medical Group/ Care Clinical Research Corporation
Banning, CA United States
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Med Institute, Inc./Mobile Physician Associates/National ACO, LLC
Beverly Hills, CA United States
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Cassidy Medical Group/Clinical Research Advantage

Cassidy Medical Group/Clinical Research Advantage
Carlsbad, CA United States
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John Muir Physician Network Clinical Research Center
Concord, CA United States
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Sillicon Valley Cardiology Medical Group

Sillicon Valley Cardiology Medical Group
E Palo Alto, CA United States
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Cardiovascular Consultants Heart Center
Fresno, CA United States
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California Heart Specialists, Inc

California Heart Specialists, Inc
Huntington Beach, CA United States
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Alliance Clinical Research
Laguna Hills, CA United States
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Larkspur, CA United States
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HealthCare Partners Long Beach
Long Beach, CA United States
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Long Beach, CA United States
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Los Alamitos, CA United States
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Los Angeles, CA United States
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Los Angeles, CA United States
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Manhattan Beach, CA United States
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Mission Hills, CA United States
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Newport Beach, CA United States
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Northridge, CA United States
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Foothill Cardiology
Pasadena, CA United States
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HealthCarePartners Del Mar
Pasadena, CA United States
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Pasadena, CA United States
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Pomona, CA United States
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Poway, CA United States
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Torrance, CA United States
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Torrance, CA United States
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Torrance, CA United States
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Torrence, CA United States
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Ventura Cardiology Consultants Medical Group Inc.
Ventura, CA United States
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Aurora, CO United States
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Colorado Cardiac Alliance, LLC

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Colorado Springs, CO United States
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Colorado Springs, CO United States
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Lakewood, CO United States
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Bridgeport, CT United States
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Laurel, DE United States
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Clearwater, FL United States
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Coral Springs, FL United States
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Eustis, FL United States
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Jupiter, FL United States
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Lakeland, FL United States
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Miami, FL United States
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Miami, FL United States
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Palm Harbor, FL United States
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Pensacola, FL United States
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Port Charlotte, FL United States
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Tampa, FL United States
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Wellington, FL United States
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Alpharetta, GA United States
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Athens, GA United States
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Atlanta, GA United States
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Marietta, GA United States
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Rome, GA United States
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Hines, IL United States
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Consultants in Cardiovascular Medicine
Melrose Park, IL United States
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New Lenox, IL United States
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North Chicago, IL United States
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Peoria, IL United States
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Rock Island, IL United States
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Anderson, IN United States
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Bloomington, IN United States
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Hammond, IN United States
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Indianapolis, IN United States
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La Porte, IN United States
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Cardiovascular Research of Northwest Indiana

Cardiovascular Research of Northwest Indiana
Munster, IN United States
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Cardiology Associates Incorporated

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South Bend, IN United States
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South Bend, IN United States
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Waterloo, IA United States
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Midwest Cardiology Associates

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Overland Park, KS United States
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Elizabethtown, KY United States
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Louisvile, KY United States
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Alexandria, LA United States
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Natchitoches, LA United States
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New Orleans, LA United States
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New Orleans, LA United States
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Shreveport, LA United States
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Rockport, ME United States
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Anne Arundel Health System Research Institute
Annapolis, MD United States
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Baltimore, MD United States
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Sinai Hospital of Baltimore
Baltimore, MD United States
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Northwest Hospital Center of Baltimore
Randallstown, MD United States
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Peninsula Cardiology Associates
Salisbury, MD United States
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NECCR Internal Medicine and Cardiology, LLC
Fall River, MA United States
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Endeavor Medical Research

Endeavor Medical Research
Alpena, MI United States
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Bay Regional Medical Center
Bay City, MI United States
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Cardiology Institute of Michigan

Cardiology Institute of Michigan
Flint, MI United States
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Genesys Reg Medical Cntr-surgery-general
Grand Blanc, MI United States
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Thoracic & Cardiovascular Heatlhcare Foundation

Thoracic & Cardiovascular Heatlhcare Foundation
Lansing, MI United States
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Cardiology Consultants of East Michigan
Lapeer, MI United States
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Mount Clemens, MI United States
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Rochester Hills, MI United States
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Great Lakes Heart & Vascular Institute
St. Joseph, MI United States
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Traverse City, MI United States
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Beaumont Health System
Troy, MI United States
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Michigan Heart & Vascular Institute

Michigan Heart & Vascular Institute
Ypsilanti, MI United States
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Minneapolis Heart Institute Foundation

Minneapolis Heart Institute Foundation
Minneapolis, MN United States
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West Florissant Internists/Clinical Research Advantage, Inc.
Bridgeton, MO United States
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Truman Medical Ctr-west
Kansas City, MO United States
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Prairie Fields Family Medicine/Clinical Research Advantage
Fremont, NE United States
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Clinical Research of South Nevada

Clinical Research of South Nevada
Las Vegas, NV United States
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CIMA Medical Research Inc.
Las Vegas, NV United States
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St Mary's Regional Medical Center
Reno, NV United States
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Lahey Cardiology at the Medical ...

Lahey Cardiology at the Medical Center
Nashua, NH United States
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Advanced Heart Care, LLC

Advanced Heart Care, LLC
Bridgewater, NJ United States
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Cardiology Associates of Somerset County

Cardiology Associates of Somerset County
Bridgewater, NJ United States
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Rakesh K Passi, MD LLC

Rakesh K Passi, MD LLC
East Brunswick, NJ United States
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Hunterdon Cardiovascular Associates

Hunterdon Cardiovascular Associates
Flemington, NJ United States
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NJ Heart
Linden, NJ United States
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JPAZ Perfection Clinical, LLC
Manalapan, NJ United States
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Virtua Medical Group, P.A. d/b/a Virtua Cardiology Group
Moorestown, NJ United States
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Lakeland Cardiology

Lakeland Cardiology
Mountain Lakes, NJ United States
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Cardio Metabolic Institute

Cardio Metabolic Institute
Somerset, NJ United States
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Toms River, NJ United States
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Virtua Medical Group, P.A. d/b/a Virtua Cardiology Group
Voorhees, NJ United States
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Cardiology Associates of North Jersey

Cardiology Associates of North Jersey
Wayne, NJ United States
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Samuel S. Stratton Verterans Affairs Medical Center
Albany, NY United States
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Jamaica, NY United States
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Jamestown, NY United States
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Lake Success, NY United States
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Mineola, NY United States
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Mount Kisco, NY United States
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North Massapequa, NY United States
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Utica, NY United States
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Chapel, NC United States
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Durham, NC United States
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Elizabeth City, NC United States
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LeBauer Cardiovascular Research Foundation at CONE Health
Greensboro, NC United States
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Pinehurst Medical Clinic
Pinehurst, NC United States
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Family Medical Associates of Raleigh
Raleigh, NC United States
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Sanford, NC United States
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Spartanburg, NC United States
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Canton, OH United States
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Cleveland, OH United States
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Columbus, OH United States
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Mansfield, OH United States
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Miamisburg, OH United States
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Toledo, OH United States
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Worthington, OH United States
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Youngstown, OH United States
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Tulsa, OK United States
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Medford, OR United States
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Oregon Health & Science University
Portland, OR United States
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Abington, PA United States
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Abington, PA United States
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Chambersburg, PA United States
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Doylestown, PA United States
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Doylestown, PA United States
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Ephrata, PA United States
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Langhorne, PA United States
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Detweiler Family Medicine and Associates
Lansdale, PA United States
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Jefferson Coordinating Center for Clinical ...

Jefferson Coordinating Center for Clinical Research
Philadelphia, PA United States
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Drexel University College of Medicine
Phildelphia, PA United States
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Donald Guthrie Foundation for Education and Research, Inc.
Sayre, PA United States
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West Reading, PA United States
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Wynnewood, PA United States
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Yardley, PA United States
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Providence, RI United States
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Providence, RI United States
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Warwick, RI United States
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Woonsocket, RI United States
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Charleston, SC United States
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Lancaster, SC United States
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Bristol, TN United States
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Jackson, TN United States
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Kingsport, TN United States
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Kingsport, TN United States
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Kingsport, TN United States
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Memphis, TN United States
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Nashville, TN United States
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Oak Ridge, TN United States
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Seton Heart Institute

Seton Heart Institute
Austin, TX United States
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Texas Cardiac Arrhythmia Research Foundation

Texas Cardiac Arrhythmia Research Foundation
Austin, TX United States
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Austin Heart PLLC

Austin Heart PLLC
Austin, TX United States
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Southeast Texas Clinical Research Center

Southeast Texas Clinical Research Center
Beaumont, TX United States
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Corpus Christi, TX United States
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VA North Texas Health Care System
Dallas, TX United States
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Brooke Army Medical Center
Fort Sam Houston, TX United States
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Amir Malik Research
Fort Worth, TX United States
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Texas Health Physicians Group
Ft. Worth, TX United States
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Angiocardiac Care of Texas, PA

Angiocardiac Care of Texas, PA
Houston, TX United States
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Jimin Wang, MD, PA

Jimin Wang, MD, PA
Houston, TX United States
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Dairy Ashford Family Practice
Houston, TX United States
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Cardiology Center of Houston, PA

Cardiology Center of Houston, PA
Katy, TX United States
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West Memorial Family Practice
Katy, TX United States
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Cardiac Center of Texas PA

Cardiac Center of Texas PA
Mckinney, TX United States
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Permian Research Foundation

Permian Research Foundation
Odessa, TX United States
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Grace Research, LLC - Palestine

Grace Research, LLC - Palestine
Palestine, TX United States
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Plano Internal Medicine Associates Clinical Research Advantage, Inc.
Plano, TX United States
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Scott & White Healthcare
Round Rock, TX United States
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Cardiac Center of San Antonio

Cardiac Center of San Antonio
San Antonio, TX United States
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Lone Star Heart and Vascular Care Center
Tomball, TX United States
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Northwest Houston Clinical Research

Northwest Houston Clinical Research
Tomball, TX United States
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Tyler Cardiovascular Consultants

Tyler Cardiovascular Consultants
Tyler, TX United States
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Dominion Biomedical Research Alliance, Inc.

Dominion Biomedical Research Alliance, Inc.
Annandale, VA United States
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Centra Health Cardiovascular Group
Lynchburg, VA United States
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Richmond Cardiology Associates
Mechanicsville, VA United States
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Cardiovascular Associates of Virginia

Cardiovascular Associates of Virginia
Midlothian, VA United States
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Riverside Cardiology Specialists
Newport News, VA United States
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Cardiovascular Associates, Ltd.
Virginia Beach, VA United States
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University of Washington

University of Washington
Seattle, WA United States
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Multicare Health Systems

Multicare Health Systems
Tacoma, WA United States
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Universal Research Group, LLC

Universal Research Group, LLC
Tacoma, WA United States
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Northwest Medical Associates P.S. -222 ...

Northwest Medical Associates P.S. -222 NE Park Plaza Dr.
Vancouver, WA United States
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Walla Walla Clinic

Walla Walla Clinic
Walla Walla, WA United States
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CAMC Clinical Trials Center

CAMC Clinical Trials Center
Charleston, WV United States
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Charleston Internal Medicine

Charleston Internal Medicine
Charleston, WV United States
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FSH/Mayo Health System

FSH/Mayo Health System
La Crosse, WI United States
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Aurora Saint Lukes Medical Center

Aurora Saint Lukes Medical Center
Milwaukee, WI United States
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ProHealth Care

ProHealth Care
Waukesha, WI United States
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Aspirus Heart & Vascular Institute-Research ...

Aspirus Heart & Vascular Institute-Research & Education
Wausau, WI United States
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Denis Ruiz Serrano Cardologia

Denis Ruiz Serrano Cardologia
Rio Grande, Puerto Rico
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Virgin Islands Heart

Virgin Islands Heart
St. Thomas, Virgin Islands (U.S.)
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Recruitment Status: Open


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