We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

SJM Brady MRI Post Approval Study (Brady MRI PAS)

This study is currently recruiting participants.
Verified September 2017 by St. Jude Medical
Sponsor:
ClinicalTrials.gov Identifier:
NCT03170583
First Posted: May 31, 2017
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical
  Purpose
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.

Condition Intervention
Bradycardia Device: St. Jude Medical Tendril MRI™ lead

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: SJM Brady MRI Post Approval Study

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Freedom from Tendril MRI RA lead-related complications through 60 months of follow up [ Time Frame: 60 months ]
  • Freedom from Tendril MRI RV lead-related complications through 60 months of follow up [ Time Frame: 60 months ]
  • MRI scan related complications rate through one-month following the MRI scan [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • The complication rate of the Tendril MRI lead [ Time Frame: 60 months ]

Estimated Enrollment: 1756
Actual Study Start Date: June 8, 2017
Estimated Study Completion Date: September 1, 2025
Estimated Primary Completion Date: August 1, 2025 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: St. Jude Medical Tendril MRI™ lead
    pacemaker, leads
    Other Names:
    • St. Jude Medical Accent MRI™ pacemaker
    • St. Jude Medical Assurity MRI™ pacemaker
    • St. Jude Medical Endurity MRI™pacemaker
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.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with a standard bradycardia indication.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170583


Contacts
Contact: Nikesha N Harrington, BA 972-426-4813 nharrington03@sjm.com
Contact: Grant Kim, MS 818-493-3147 gkim@sjm.com

Locations
United States, Arkansas
Cardiology Associates of North East Arkansas Recruiting
Jonesboro, Arkansas, United States, 72401
Contact: David Nair, MD         
Arkansas Heart Hospital Recruiting
Little Rock, Arkansas, United States, 72211
Contact: Wilson Wong, MD         
Mercy Hospital Northwest Arkansas Recruiting
Rogers, Arkansas, United States, 72758
Contact: Amr El-Shafei, MD         
United States, California
Raymond Schaerf, MD Recruiting
Burbank, California, United States, 91505
Contact: Raymond Schaerf, MD         
United States, Florida
Cardiology Partners Recruiting
Wellington, Florida, United States, 33449
Contact: Amarnath R Vedere, MD         
United States, Georgia
Piedmont Athens Regional Medical Center Recruiting
Athens, Georgia, United States, 30606
Contact: David Woodard, MD         
Atlanta Heart Specialist Recruiting
Cumming, Georgia, United States, 30041
Contact: Narendra Singh, MD         
United States, Louisiana
Ochsner Medical Center Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Paul Rogers, MD         
United States, Michigan
Sparrow Clinical Research Institute Recruiting
Lansing, Michigan, United States, 48912
Contact: John Ip, MD         
United States, Mississippi
Jackson Heart Clinic Recruiting
Jackson, Mississippi, United States, 39216
Contact: Judson Colley, MD         
United States, Missouri
Missouri Baptist Medical Center Recruiting
Saint Louis, Missouri, United States, 63131
Contact: Andrew Krainik, MD, MPH         
United States, New York
New York Presbyterian Hospital/Cornell University Recruiting
New York, New York, United States, 10021
Contact: Steven M Markowitz, MD         
United States, North Carolina
Novant Health Heart and Vascular Research Institute Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Russ Bailey, MD         
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Mahmoud Houmsse, MD         
United States, Pennsylvania
Abington Medical Specialists Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Charles Gottlieb, MD         
Donald Guthrie Foundation for Education and Research Recruiting
Sayre, Pennsylvania, United States, 18840
Contact: Pramod Deshmukh, MD         
United States, Texas
South Texas Cardiovascular Consultants Recruiting
San Antonio, Texas, United States, 78201
Contact: Javier R Gonzalez, MD         
Sponsors and Collaborators
St. Jude Medical
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT03170583     History of Changes
Other Study ID Numbers: SJM-CIP- CL1000304
First Submitted: May 26, 2017
First Posted: May 31, 2017
Last Update Posted: October 2, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by St. Jude Medical:
bradycardia, pacemaker, MRI scan

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes