SJM Brady MRI Post Approval Study (Brady MRI PAS)

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.

Study Overview

• Status: Terminated
• Conditions: Bradycardia
• Intervention / Treatment: Device: St. Jude Medical Tendril MRI™ lead

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.

• Study Type: Observational
• Enrollment (Actual): 1768

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Phoenix Cardiovascular Research Group
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Cardiology Associates of North East Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Heart Hospital
    • Rogers, Arkansas, United States, 72758
      • Mercy Hospital Northwest Arkansas
  • California
    • Bakersfield, California, United States, 93308
      • Central Cardiology
    • Burbank, California, United States, 91505
      • Raymond Schaerf, MD
    • Deer Park, California, United States, 94576
      • St. Helena Hospital
    • Los Angeles, California, United States, 90033
      • USC University Hospital
    • Riverside, California, United States, 92506
      • Riverside Medical Clinic
    • Sacramento, California, United States, 95816
      • Sutter Medical Center, Sacramento
    • San Diego, California, United States, 92103
      • University of California at San Diego (UCSD) Medical Center
    • San Diego, California, United States, 92103
      • San Diego Heart Rhythm Center
  • Florida
    • Atlantis, Florida, United States, 33462
      • Medical Specialists of the Palm Beaches
    • Brandon, Florida, United States, 33511
      • Bay Area Cardiology Associates PA
    • Jacksonville, Florida, United States, 32209
      • Shands Jacksonville
    • South Miami, Florida, United States, 33143
      • Hrachian Hakop MD PA
    • Wellington, Florida, United States, 33449
      • Cardiology Partners
  • Georgia
    • Athens, Georgia, United States, 30606
      • Piedmont Athens Regional Medical Center
    • Cumming, Georgia, United States, 30041
      • Atlanta Heart Specialist
    • Macon, Georgia, United States, 31217
      • Coliseum Medical Centers
  • Kentucky
    • Lexington, Kentucky, United States, 40636
      • University of Kentucky
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Auburn Hills, Michigan, United States, 48326
      • McLaren Health Care Corporation
    • Lansing, Michigan, United States, 48912
      • Sparrow Clinical Research Institute
    • Midland, Michigan, United States, 48670
      • MidMichigan Medical Center-Midland
    • Traverse City, Michigan, United States, 49684
      • Munson Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Jackson Heart Clinic
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Missouri Heart Center
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hospital
    • Saint Louis, Missouri, United States, 63131
      • Missouri Baptist Medical Center
  • Nebraska
    • Kearney, Nebraska, United States, 68845
      • Kearney Regional Medical Center
    • Lincoln, Nebraska, United States, 68506
      • BryanLGH Medical Center East
  • New Jersey
    • Haddon Heights, New Jersey, United States, 08035
      • Cardiovascular Associates of the Delaware Valley
    • Livingston, New Jersey, United States, 07039
      • Saint Barnabas Medical Center
    • Somerset, New Jersey, United States, 008873
      • New Brunswick Cardiology Group
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • New Mexico Heart Institute
  • New York
    • Albany, New York, United States, 12211
      • Capital Cardiology Associates
    • New York, New York, United States, 10021
      • New York Presbyterian Hospital/Cornell University
    • Poughkeepsie, New York, United States, 12601
      • Hudson Valley Cardiovascular Practice, P.C.
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Novant Health Heart and Vascular Research Institute
    • Greenville, North Carolina, United States, 27834
      • East Carolina Heart Institute
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43210
      • Ohio State University
    • Toledo, Ohio, United States, 43606
      • The Toledo Hospital
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington Medical Specialists
    • Harrisburg, Pennsylvania, United States, 17105
      • Pinnacle Health System
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
    • Sayre, Pennsylvania, United States, 18840
      • Donald Guthrie Foundation for Education and Research
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Trident Medical Center
    • Greenville, South Carolina, United States, 29601
      • St. Francis Hospital
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Regional Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Medical Center
    • Germantown, Tennessee, United States, 38138
      • The Stern Cardiovascular Foundation
  • Texas
    • College Station, Texas, United States, 77845
      • BCS Heart, LLP
    • Dallas, Texas, United States, 75230
      • Medical City Dallas Hospital
    • Fort Worth, Texas, United States, 76104
      • Fort Worth Heart
    • Houston, Texas, United States, 77030
      • Houston Cardiovascular Associates
    • San Antonio, Texas, United States, 78201
      • South Texas Cardiovascular Consultants
  • Virginia
    • Manassas, Virginia, United States, 20109
      • Carient Heart & Vascular, P.C.
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
  • Wisconsin
    • Marshfield, Wisconsin, United States, 54449
      • Marshfield Clinic
    • Milwaukee, Wisconsin, United States, 53204
      • Aurora Medical Group
    • Wausau, Wisconsin, United States, 54401
      • Aspirus Wausau Hospital
  • Wyoming
    • Cheyenne, Wyoming, United States, 82001
      • Cheyenne Cardiology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with a standard bradycardia indication.

Description

Inclusion Criteria:

1. Subject is able to provide informed consent for study participation (legally authorized representative is NOT acceptable).
2. Subject is at least 18 years of age or of legal age to give informed consent specific to state and national law.

3. Subject meets at least one of the following criteria:

   1. 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.
   2. 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.
   3. 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.
4. Subject is willing and able to comply with the prescribed follow-up tests and schedule of evaluations including MRI scan procedures.

Exclusion Criteria:

1. 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.
2. 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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
The complication rate of the Tendril MRI lead	60 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Grant Kim, MS, Abbott (formerly St. Jude Medical)

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2017
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: May 26, 2017
• First Submitted That Met QC Criteria: May 26, 2017
• First Posted (Actual): May 31, 2017

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 24, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: bradycardia, pacemaker, MRI scan
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Bradycardia
• Other Study ID Numbers: SJM-CIP- CL1000304

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No