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

Contact Investigators or Research Sites near you

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Arkansas Heart Hospital

Little Rock, AR United States
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Raymond Schaerf, MD

Burbank, CA United States
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Cardiology Partners

Wellington, FL United States
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Atlanta Heart Specialist

Cumming, GA United States
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Ochsner Medical Center

New Orleans, LA United States
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Jackson Heart Clinic

Jackson, MS United States
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Missouri Baptist Medical Center

Saint Louis, MO United States
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Ohio State University

Columbus, OH United States
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Abington Medical Specialists

Abington, PA United States
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Central Cardiology

Bakersfield, CA United States
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USC University Hospital

Los Angeles, CA United States
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Riverside Medical Clinic

Riverside, CA United States
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San Diego Heart Rhythm Center

San Diego, CA United States
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Shands Jacksonville

Jacksonville, FL United States
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Hrachian Hakop MD PA

South Miami, FL United States
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Coliseum Medical Centers

Macon, GA United States
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University of Kentucky

Lexington, KY United States
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McLaren Health Care Corporation

Auburn Hills, MI United States
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Munson Medical Center

Traverse City, MI United States
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Minneapolis Heart Institute

Minneapolis, MN United States
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Missouri Heart Center

Columbia, MO United States
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St. Luke's Hospital

Kansas City, MO United States
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Saint Barnabas Medical Center

Livingston, NJ United States
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The Toledo Hospital

Toledo, OH United States
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Pinnacle Health System

Harrisburg, PA United States
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St. Francis Hospital

Greenville, SC United States
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Erlanger Medical Center

Chattanooga, TN United States
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BCS Heart, LLP

College Station, TX United States
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Fort Worth Heart

Fort Worth, TX United States
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Aurora Medical Group

Milwaukee, WI United States
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Aspirus Wausau Hospital

Wausau, WI United States
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Recruitment Status: Open

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