SJM Brady MRI Post Approval Study
- Conditions
- Bradycardia
- Registration Number
- NCT03170583
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
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 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1768
-
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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Freedom from Tendril MRI RA lead-related complications through 60 months of follow up 60 months Freedom from Tendril MRI RV lead-related complications through 60 months of follow up 60 months MRI scan related complications rate through one-month following the MRI scan 1 month
- Secondary Outcome Measures
Name Time Method The complication rate of the Tendril MRI lead 60 months
Trial Locations
- Locations (66)
USC University Hospital
🇺🇸Los Angeles, California, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Saint Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
Aspirus Wausau Hospital
🇺🇸Wausau, Wisconsin, United States
Central Cardiology
🇺🇸Bakersfield, California, United States
Raymond Schaerf, MD
🇺🇸Burbank, California, United States
St. Helena Hospital
🇺🇸Deer Park, California, United States
Riverside Medical Clinic
🇺🇸Riverside, California, United States
Medical Specialists of the Palm Beaches
🇺🇸Atlantis, Florida, United States
Bay Area Cardiology Associates PA
🇺🇸Brandon, Florida, United States
Hrachian Hakop MD PA
🇺🇸South Miami, Florida, United States
Shands Jacksonville
🇺🇸Jacksonville, Florida, United States
Cardiology Partners
🇺🇸Wellington, Florida, United States
Coliseum Medical Centers
🇺🇸Macon, Georgia, United States
Piedmont Athens Regional Medical Center
🇺🇸Athens, Georgia, United States
Atlanta Heart Specialist
🇺🇸Cumming, Georgia, United States
MidMichigan Medical Center-Midland
🇺🇸Midland, Michigan, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
Sparrow Clinical Research Institute
🇺🇸Lansing, Michigan, United States
Missouri Baptist Medical Center
🇺🇸Saint Louis, Missouri, United States
Missouri Heart Center
🇺🇸Columbia, Missouri, United States
BryanLGH Medical Center East
🇺🇸Lincoln, Nebraska, United States
New Mexico Heart Institute
🇺🇸Albuquerque, New Mexico, United States
New York Presbyterian Hospital/Cornell University
🇺🇸New York, New York, United States
Capital Cardiology Associates
🇺🇸Albany, New York, United States
East Carolina Heart Institute
🇺🇸Greenville, North Carolina, United States
Novant Health Heart and Vascular Research Institute
🇺🇸Charlotte, North Carolina, United States
Hudson Valley Cardiovascular Practice, P.C.
🇺🇸Poughkeepsie, New York, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Abington Medical Specialists
🇺🇸Abington, Pennsylvania, United States
The Toledo Hospital
🇺🇸Toledo, Ohio, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Donald Guthrie Foundation for Education and Research
🇺🇸Sayre, Pennsylvania, United States
The Stern Cardiovascular Foundation
🇺🇸Germantown, Tennessee, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
BCS Heart, LLP
🇺🇸College Station, Texas, United States
Fort Worth Heart
🇺🇸Fort Worth, Texas, United States
Houston Cardiovascular Associates
🇺🇸Houston, Texas, United States
Carient Heart & Vascular, P.C.
🇺🇸Manassas, Virginia, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Cheyenne Cardiology Associates
🇺🇸Cheyenne, Wyoming, 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
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States
South Texas Cardiovascular Consultants
🇺🇸San Antonio, Texas, United States
St. Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Aurora Medical Group
🇺🇸Milwaukee, Wisconsin, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Phoenix Cardiovascular Research Group
🇺🇸Phoenix, Arizona, United States
Jackson Heart Clinic
🇺🇸Jackson, Mississippi, United States
St. Francis Hospital
🇺🇸Greenville, South Carolina, United States
Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Cardiology Associates of North East Arkansas
🇺🇸Jonesboro, Arkansas, United States
Cardiovascular Associates of the Delaware Valley
🇺🇸Haddon Heights, New Jersey, United States
New Brunswick Cardiology Group
🇺🇸Somerset, New Jersey, United States
Erlanger Medical Center
🇺🇸Chattanooga, Tennessee, United States
Kearney Regional Medical Center
🇺🇸Kearney, Nebraska, United States
Arkansas Heart Hospital
🇺🇸Little Rock, Arkansas, United States
Mercy Hospital Northwest Arkansas
🇺🇸Rogers, Arkansas, United States
Sutter Medical Center, Sacramento
🇺🇸Sacramento, California, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
Trident Medical Center
🇺🇸Charleston, South Carolina, United States
Pinnacle Health System
🇺🇸Harrisburg, Pennsylvania, United States
McLaren Health Care Corporation
🇺🇸Auburn Hills, Michigan, United States