SJM Brady MRI Post Approval Study

Stopped early

Conditions studied: Bradycardia

In brief

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.

Key facts

Study ID

NCT03170583

Run by

Abbott Medical Devices

People needed

1768

Starts

2017-06-08

Expected to finish

2020-06-30

Last updated by the study team

2020-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is able to provide informed consent for study participation (legally authorized representative is NOT acceptable).
• Subject is at least 18 years of age or of legal age to give informed consent specific to state and national law.
• Subject meets at least one of the following criteria:
• Is an Accent MRI IDE study subject who is being rolled over into the SJM Brady MRI PAS and still has at least one Tendril MRI™ lead implanted with a SJM Brady MRI pacemaker such as the Accent MRI or similar model.
• Is a subject who has been implanted with at least one Tendril MRI lead and a SJM Brady MRI pacemaker such as the Accent MRI or similar model, but is not part of the Accent MRI IDE study and will be enrolled within 30 days after implant.
• Is a subject who will be implanted with at least one Tendril MRI lead and a SJM Brady MRI pacemaker such as the Accent MRI or similar model and will be consented either at or within 30 days before implant.
• Subject is willing and able to comply with the prescribed follow-up tests and schedule of evaluations including MRI scan procedures.

You may not qualify if…

• Subject has been enrolled or intends to participate in a clinical drug and/or device study with an active treatment arm or that has any procedures, which could confound the results of this trial.
• Subject is not expected to be able to complete the study follow up schedule or duration due to any health condition such as has malignancy, is deemed a candidate for transplant or Ventricular Assist Device, or in hospice care.

Where it is running

• Cardiology Associates of North East Arkansas — Jonesboro, Arkansas, United States
• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• Mercy Hospital Northwest Arkansas — Rogers, Arkansas, United States
• Central Cardiology — Bakersfield, California, United States
• Raymond Schaerf, MD — Burbank, California, United States
• St. Helena Hospital — Deer Park, California, United States
• USC University Hospital — Los Angeles, California, United States
• Riverside Medical Clinic — Riverside, California, United States
• Sutter Medical Center, Sacramento — Sacramento, California, United States
• San Diego Heart Rhythm Center — San Diego, California, United States
• University of California at San Diego (UCSD) Medical Center — San Diego, California, United States
• Medical Specialists of the Palm Beaches — Atlantis, Florida, United States
• Bay Area Cardiology Associates PA — Brandon, Florida, United States
• Shands Jacksonville — Jacksonville, Florida, United States
• Hrachian Hakop MD PA — South Miami, Florida, United States
• Cardiology Partners — Wellington, Florida, United States
• Piedmont Athens Regional Medical Center — Athens, Georgia, United States
• Atlanta Heart Specialist — Cumming, Georgia, United States
• Coliseum Medical Centers — Macon, Georgia, United States
• University of Kentucky — Lexington, Kentucky, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• McLaren Health Care Corporation — Auburn Hills, Michigan, United States
• Sparrow Clinical Research Institute — Lansing, Michigan, United States
• Phoenix Cardiovascular Research Group — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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