Study Stopped
Abbott received FDA approval to transition the ongoing Brady MRI PAS study to EP a new EP-Passion Real World Evidence methodology
SJM Brady MRI Post Approval Study
Brady MRI PAS
1 other identifier
observational
1,768
1 country
66
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2017
Typical duration for all trials
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2017
CompletedFirst Posted
Study publicly available on registry
May 31, 2017
CompletedStudy Start
First participant enrolled
June 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedJuly 28, 2020
July 1, 2020
3.1 years
May 26, 2017
July 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
The complication rate of the Tendril MRI lead
60 months
Interventions
pacemaker, leads
Eligibility Criteria
Patients with a standard bradycardia indication.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (66)
Phoenix Cardiovascular Research Group
Phoenix, Arizona, 85018, United States
Cardiology Associates of North East Arkansas
Jonesboro, Arkansas, 72401, United States
Arkansas Heart Hospital
Little Rock, Arkansas, 72211, United States
Mercy Hospital Northwest Arkansas
Rogers, Arkansas, 72758, United States
Central Cardiology
Bakersfield, California, 93308, United States
Raymond Schaerf, MD
Burbank, California, 91505, United States
St. Helena Hospital
Deer Park, California, 94576, United States
USC University Hospital
Los Angeles, California, 90033, United States
Riverside Medical Clinic
Riverside, California, 92506, United States
Sutter Medical Center, Sacramento
Sacramento, California, 95816, United States
San Diego Heart Rhythm Center
San Diego, California, 92103, United States
University of California at San Diego (UCSD) Medical Center
San Diego, California, 92103, United States
Medical Specialists of the Palm Beaches
Atlantis, Florida, 33462, United States
Bay Area Cardiology Associates PA
Brandon, Florida, 33511, United States
Shands Jacksonville
Jacksonville, Florida, 32209, United States
Hrachian Hakop MD PA
South Miami, Florida, 33143, United States
Cardiology Partners
Wellington, Florida, 33449, United States
Piedmont Athens Regional Medical Center
Athens, Georgia, 30606, United States
Atlanta Heart Specialist
Cumming, Georgia, 30041, United States
Coliseum Medical Centers
Macon, Georgia, 31217, United States
University of Kentucky
Lexington, Kentucky, 40636, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
McLaren Health Care Corporation
Auburn Hills, Michigan, 48326, United States
Sparrow Clinical Research Institute
Lansing, Michigan, 48912, United States
MidMichigan Medical Center-Midland
Midland, Michigan, 48670, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
Jackson Heart Clinic
Jackson, Mississippi, 39216, United States
Missouri Heart Center
Columbia, Missouri, 65201, United States
St. Luke's Hospital
Kansas City, Missouri, 64111, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Kearney Regional Medical Center
Kearney, Nebraska, 68845, United States
BryanLGH Medical Center East
Lincoln, Nebraska, 68506, United States
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, 08035, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
New Brunswick Cardiology Group
Somerset, New Jersey, 008873, United States
New Mexico Heart Institute
Albuquerque, New Mexico, 87102, United States
Capital Cardiology Associates
Albany, New York, 12211, United States
New York Presbyterian Hospital/Cornell University
New York, New York, 10021, United States
Hudson Valley Cardiovascular Practice, P.C.
Poughkeepsie, New York, 12601, United States
Novant Health Heart and Vascular Research Institute
Charlotte, North Carolina, 28204, United States
East Carolina Heart Institute
Greenville, North Carolina, 27834, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
The Toledo Hospital
Toledo, Ohio, 43606, United States
Abington Medical Specialists
Abington, Pennsylvania, 19001, United States
Pinnacle Health System
Harrisburg, Pennsylvania, 17105, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Donald Guthrie Foundation for Education and Research
Sayre, Pennsylvania, 18840, United States
Trident Medical Center
Charleston, South Carolina, 29406, United States
St. Francis Hospital
Greenville, South Carolina, 29601, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
Erlanger Medical Center
Chattanooga, Tennessee, 37403, United States
The Stern Cardiovascular Foundation
Germantown, Tennessee, 38138, United States
BCS Heart, LLP
College Station, Texas, 77845, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
Fort Worth Heart
Fort Worth, Texas, 76104, United States
Houston Cardiovascular Associates
Houston, Texas, 77030, United States
South Texas Cardiovascular Consultants
San Antonio, Texas, 78201, United States
Carient Heart & Vascular, P.C.
Manassas, Virginia, 20109, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Aurora Medical Group
Milwaukee, Wisconsin, 53204, United States
Aspirus Wausau Hospital
Wausau, Wisconsin, 54401, United States
Cheyenne Cardiology Associates
Cheyenne, Wyoming, 82001, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Grant Kim, MS
Abbott (formerly St. Jude Medical)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2017
First Posted
May 31, 2017
Study Start
June 8, 2017
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
July 28, 2020
Record last verified: 2020-07