Last updated on February 2018

AMPLATZER Amulet LAA Occluder Trial

Brief description of study

The Amulet device will be evaluated for safety and efficacy by demonstrating its performance is non-inferior to the commercially available WATCHMAN left atrial appendage closure device in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the Amulet device or the WATCHMAN device and will be followed for 5 years after device implant.

Detailed Study Description

The Amulet IDE trial is a prospective, randomized, multi-center active control worldwide trial, designed to evaluate the safety and effectiveness of the AMPLATZER Amulet Left Atrial Appendage Occluder. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device (treatment) or a Boston Scientific WATCHMAN LAA closure device (Control). The trial will be conducted at up to 150 sites worldwide. All enrolled subjects will follow the protocol-required tests and assessments at each scheduled follow-up visit.

Clinical Study Identifier: NCT02879448

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Scott Allison, MD

Heart Center Research, LLC.
Huntsville, AL United States
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Vijendra Swarup, MD

Arizona Arrhythmia Research Center
Phoenix, AZ United States
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Devi Nair, MD

Cardiology Associates of Northeast Arkansas
Jonesboro, AR United States
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Matthew Price, MD

Scripps Health
La Jolla, CA United States
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Rahul Doshi, MD

USC University Hospital
Los Angeles, CA United States
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Chad Rammohan, MD

El Camino Hospital
Mountain View, CA United States
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David Roberts, MD

Sutter Medical Center
Sacramento, CA United States
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Raghava R Gollapudi, MD

San Diego Cardiac Center
San Diego, CA United States
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Shephal Doshi, MD

Pacific Heart Institute
Santa Monica, CA United States
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Lee MacDonald, MD

South Denver Cardiology Associates PC
Littleton, CO United States
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Justin Strote, MD

Medical Center of the Rockies
Loveland, CO United States
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Daniel E Friedman, MD

Bradenton Cardiology Center
Bradenton, FL United States
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Brijeshwar S Maini, MD

Delray Medical Center
Delray Beach, FL United States
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Ruby Satpathy, MD

Baptist Medical Center
Jacksonville, FL United States
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Neal Kavesh, MD

Watson Clinic Center
Lakeland, FL United States
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Farhat S Khairallah, MD

Tallahassee Research Institute
Tallahassee, FL United States
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Michael Hoskins, MD

Emory University Hospital
Atlanta, GA United States
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Christian Spies, MD

The Queen's Medical Center
Honolulu, HI United States
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Bradley Knight, MD

Northwestern Memorial Hospital
Chicago, IL United States
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Kousik Krishnan, MD

Rush University Medical Center
Chicago, IL United States
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Manoj Duggal, MD

Advocate Christ Medical Center
Oak Lawn, IL United States
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Moeen Saleem, MD

Advocate Health and Hospitals Corporation
Oakbrook Terrace, IL United States
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James B Hermiller, MD

St. Vincent Hospital
Indianapolis, IN United States
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Dhanunjaya Lakkireddy, MD

Kansas University Medical Center
Kansas City, KS United States
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Bassem M Chehab, MD

Cardiovascular Research Institute of Kansas
Wichita, KS United States
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Gery Tomassoni, MD

Central Baptist Hospital
Lexington, KY United States
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John Gurley, MD

University of Kentucky
Lexington, KY United States
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Michael Bernard, MD

Ochsner Medical Center
New Orleans, LA United States
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Bruce Hook, MD

Lahey Clinic Medical Center
Burlington, MA United States
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William O'Neill, MD

Henry Ford Hospital
Detroit, MI United States
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Gaurav Dhar, MD

Sparrow Clinical Research Institute
Lansing, MI United States
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George Hanzel, MD

Willliam Beaumont Hospital, Royal Oak
Royal Oak, MI United States
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Stuart Adler, MD

St. Joseph's Hospital
Saint Paul, MN United States
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James Stone, MD

North Mississippi Medical Center
Tupelo, MS United States
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Kenneth Huber, MD

St. Luke's Hospital
Kansas City, MO United States
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Hosakote M Nagaraj, MD

Nebraska Heart Institute
Lincoln, NE United States
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Sajjad Sabir, MD

Cooper University Hospital
Camden, NJ United States
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Larry Chinitz, MD

New York University Hospital
New York, NY United States
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Srinivas Dukkipati, MD

Mount Sinai Hospital
New York, NY United States
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Robert Sommer, MD

Columbia University Medical Center/New York Presbyterian Hospital
New York, NY United States
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Patrick S Whalen, MD

Wake Forest University Medical Center Clinical Sciences
Winston-Salem, NC United States
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Oussama M Wazni, MD

The Cleveland Clinic Foundation
Cleveland, OH United States
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David Sandler, MD

Oklahoma Heart Institue at Utica
Tulsa, OK United States
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Amish Desai, MD

Legacy Emanuel Hospital and Health Center
Portland, OR United States
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Raveen Bazaz, MD

University of Pittsburgh Medical Center
Pittsburgh, PA United States
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Brian Schuler, MD

WellSpan Health
York, PA United States
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Matthew O'Steen, MD

Roper Hospital
Charleston, SC United States
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Frank Cuoco, MD

Medical University of South Carolina
Charleston, SC United States
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Andrew Morse, MD

St. Thomas Hospital
Nashville, TN United States
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Christopher Ellis, MD

Vanderbilt Heart Institute
Nashville, TN United States
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Rodney P Horton, MD

Texas Cardiac Arrhythmia
Austin, TX United States
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Juhana Karha, MD

Austin Heart
Austin, TX United States
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Srinivasa P Potluri, MD

The Heart Hospital Baylor Plano
Plano, TX United States
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Javier Roman Gonzalez, MD

South Texas Cardiovascular Consultants
San Antonio, TX United States
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Frederick Han, MD

University of Utah Hospital
Salt Lake City, UT United States
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Rohit Malhotra, MD

University of Virginia Medical Center
Charlottesville, VA United States
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Paul Mahoney, MD

Sentara Norfolk General Hospital
Norfolk, VA United States
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Sameer Gafoor, MD

Swedish Medical Center
Seattle, WA United States
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Mohamad Alkhouli, MD

West Virginia University Hospital
Morgantown, WV United States
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Karen Phillips, MD

Greenslopes Private Hospital
Greenslopes, Australia
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Stephen Worthley, Prof

St. Andrew's Hospital
Adelaide, Australia
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Vincent Paul, MD

HeartCare St John of God Wexford Medical Centre
Murdoch, Australia
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Lars Soendergaard, MD

Copenhagen, Denmark
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Johannes Brachmann, Prof. Dr. med

Klinikum Coburg GmbH
Coburg, Germany
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Thorsten Lewalter, Prof

Internistische Klinik dr. Mueller
Munich, Germany
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Boris Schmidt, MD

Cardioangiologisches Centrum am Bethanien Krankenhaus
Frankfurt, Germany
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Horst Sievert, Prof, MD

CardioVaskul res Centrum St. Katharinen
Frankfurt, Germany
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Carsten W Israel, MD

Evangelisches Krankenhaus Bielefeld
Bielefeld, Germany
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Thomas Schmitz, Prof. Dr. Med

Elisabeth-Krankenhaus Essen GmbH
Essen, Germany
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Tommaso Gori, Prof. Dr. med.

UNIVERSIT TSMEDIZIN der Johannes Gutenberg-Universit t Mainz
Mainz, Germany
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Ulf Landmesser, Prof, MD

Universit tsmedizin Berlin - Campus Benjamin Franklin (CBF)
Berlin, Germany
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Alexander Ghanem, MD

Asklepios Klinik St. Georg
Hamburg, Germany
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Lucas Boersma, MD

St. Antonius Ziekenhuis
Nieuwegein, Netherlands
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Rafael Ruiz Salmeron, MD

Hospital Universitario Virgen Macarena
Sevilla, Spain
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Jose F Diaz, MD

Hospital General Juan Ramon Jimenez
Huelva, Spain
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Ignacio Cruz, Prof. MD

Hospital Universitario de Salamanca
Salamanca, Spain
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Ignacio Garcia Bolao, Prof

Cl nica Universidad de Navarra
Pamplona, Spain
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Ashish Pershad, MD

Banner University Medical Center Phoenix
Phoenix, AZ United States
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Mehmet Cilingiroglu, MD

Arkansas Heart Hospital
Little Rock, AR United States
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Manish Shah, MD

Washington Hospital Center
Washington, WA United States
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Ramin Davoudi, MD

Charlton Memorial Hospital
Falls River, MA United States
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Jacob Dutcher, MD

St. Cloud Hospital (Central MN Heart Clinic)
Saint Cloud, MN United States
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Carlos E Ruiz, MD

Hackensack University Medical Center
Hackensack, NJ United States
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Mark Russo, MD

Saint Barnabas Medical Center
Livingston, NJ United States
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Robert Sommer

New York Presbyterian/Columbia University Medical Center
New York, NY United States
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Jasbir Sra, MD

Aurora Medical Group
Milwaukee, WI United States
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Werner Jung, Prof. MD

Kliniken Villingen-Schwenningen
Villingen-Schwenningen, Germany
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