Last updated on April 2018

SJM Brady MRI Post Approval Study

Brief description of study

The purpose of this post approval study is to evaluate the long-term safety of the FDA approved St. Jude Medical Tendril MRI lead implanted with a SJM Brady MRI implantable pulse generator (IPG) such as the Accent MRI, Assurity MRI, Endurity MRI pacemaker, or similar model (SJM Brady MRI System) in subjects with a standard bradycardia pacing indication.

Detailed Study Description

This is a prospective, multi-center clinical study designed to evaluate the long-term safety of the Tendril MRI lead implanted with any SJM Brady MRI pacemaker or similar model (SJM Brady MRI system) in subjects with a standard bradycardia pacing indication through 60 months of follow up.

Additionally, the study will assess the safety of the pacemaker system in subject(s) undergoing clinically indicated MRI scan(s). Any enrolled subject implanted with the SJM Brady MRI system may be included in this evaluation if they are scheduled for or planning to have a MRI scan during the course of the study.

Note: Only the Accent MRI pacemaker has not been approved by the FDA for market release. Former IDE patients implanted with the Accent MRI pacemaker are approved to rollover into this PAS. No new implants with the Accent MRI pacemaker will be enrolled.

Clinical Study Identifier: NCT03170583

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David Nair, MD

Cardiology Associates of North East Arkansas
Jonesboro, AR United States
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Wilson Wong, MD

Arkansas Heart Hospital
Little Rock, AR United States
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Amr El-Shafei, MD

Mercy Hospital Northwest Arkansas
Rogers, AR United States
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Raymond Schaerf, MD

Raymond Schaerf, MD
Burbank, CA United States
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Amarnath R Vedere, MD

Cardiology Partners
Wellington, FL United States
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David Woodard, MD

Piedmont Athens Regional Medical Center
Athens, GA United States
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Narendra Singh, MD

Atlanta Heart Specialist
Cumming, GA United States
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Paul Rogers, MD

Ochsner Medical Center
New Orleans, LA United States
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John Ip, MD

Sparrow Clinical Research Institute
Lansing, MI United States
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Judson Colley, MD

Jackson Heart Clinic
Jackson, MS United States
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Andrew Krainik, MD, MPH

Missouri Baptist Medical Center
Saint Louis, MO United States
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Steven M Markowitz, MD

New York Presbyterian Hospital/Cornell University
New York, NY United States
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Russ Bailey, MD

Novant Health Heart and Vascular Research Institute
Charlotte, NC United States
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Mahmoud Houmsse, MD

Ohio State University
Columbus, OH United States
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Charles Gottlieb, MD

Abington Medical Specialists
Abington, PA United States
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Pramod Deshmukh, MD

Donald Guthrie Foundation for Education and Research
Sayre, PA United States
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Javier R Gonzalez, MD

South Texas Cardiovascular Consultants
San Antonio, TX United States
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Marwan Bahu, MD

Phoenix Cardiovascular Research Group
Phoenix, AZ United States
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Jared Salvo, MD

Central Cardiology
Bakersfield, CA United States
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Rahul Doshi, MD

USC University Hospital
Los Angeles, CA United States
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Edward Kim, MD

Riverside Medical Clinic
Riverside, CA United States
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Subramaniam Krishnan, MD

Sutter Medical Center, Sacramento
Sacramento, CA United States
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Jigar Patel, MD

San Diego Heart Rhythm Center
San Diego, CA United States
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Alex Chernobelsky, MD

Medical Specialists of the Palm Beaches
Atlantis, FL United States
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Stephen Mester, MD

Bay Area Cardiology Associates PA
Brandon, FL United States
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John Catanzaro, MD

Shands Jacksonville
Jacksonville, FL United States
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Hakop Hrachian-Haftevani, MD

Hrachian Hakop MD PA
South Miami, FL United States
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Carmine Oddis, MD

Coliseum Medical Centers
Macon, GA United States
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Samy Claude Elayi, MD

University of Kentucky
Lexington, KY United States
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Naomi Overton, MD

McLaren Health Care Corporation
Auburn Hills, MI United States
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Brian Jaffe, MD

Munson Medical Center
Traverse City, MI United States
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Jay Sengupta, MD

Minneapolis Heart Institute
Minneapolis, MN United States
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Dan Pierce, MD

Missouri Heart Center
Columbia, MO United States
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Brian M Ramza, MD, Ph.D.

St. Luke's Hospital
Kansas City, MO United States
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Robert Percell, MD

BryanLGH Medical Center East
Lincoln, NE United States
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George E Mark, MD

Cardiovascular Associates of the Delaware Valley
Haddon Heights, NJ United States
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Marc Roelke, MD

Saint Barnabas Medical Center
Livingston, NJ United States
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Subhashini Gowda, MD

New Brunswick Cardiology Group
Somerset, NJ United States
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Ian Santoro, MD

Capital Cardiology Associates
Albany, NY United States
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Sankar Varansi, MD

Hudson Valley Cardiovascular Practice, P.C.
Poughkeepsie, NY United States
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Daniel Cantillon, MD

The Cleveland Clinic Foundation
Cleveland, OH United States
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Timothy Phelan, MD

The Toledo Hospital
Toledo, OH United States
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Chinmay Patel, MD

Pinnacle Health System
Harrisburg, PA United States
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Soraya Samii, MD, PhD, FACC, ...

Penn State Milton S. Hershey Medical Center
Hershey, PA United States
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Craig J McCotter, EP

St. Francis Hospital
Greenville, SC United States
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Harish Manyam, MD

Erlanger Medical Center
Chattanooga, TN United States
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Jeffrey E Kerlan, MD

The Stern Cardiovascular Foundation
Germantown, TN United States
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Lane Miller, MD

BCS Heart, LLP
College Station, TX United States
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Michael Isaac, MD

Medical City Dallas Hospital
Dallas, TX United States
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Nayyar S Shah, MD

Fort Worth Heart
Fort Worth, TX United States
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Allen Cuiffo, MD

Sentara Norfolk General Hospital
Norfolk, VA United States
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M Eyman Mortada, MD

Aurora Medical Group
Milwaukee, WI United States
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Kevin E. Rist, MD

Aspirus Wausau Hospital
Wausau, WI United States
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Oussama Lawand, MD

Cheyenne Cardiology Associates
Cheyenne, WY United States
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Recruitment Status: Open

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