ClinicalTrials.gov
ClinicalTrials.gov Menu

SJM Brady MRI Post Approval Study (Brady MRI PAS)

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.
ClinicalTrials.gov Identifier: NCT03170583
Recruitment Status : Recruiting
First Posted : May 31, 2017
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

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.

Condition or disease Intervention/treatment
Bradycardia 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.

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.


Study Type : Observational
Estimated Enrollment : 1756 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SJM Brady MRI Post Approval Study
Actual Study Start Date : June 8, 2017
Estimated Primary Completion Date : August 1, 2025
Estimated Study Completion Date : September 1, 2025

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


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

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


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, Older Adult)
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.

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 nikesha.harrington@abbott.com
Contact: Grant Kim, MS 818-493-3147 grant.kim1@abbott.com

  Show 54 Study Locations
Sponsors and Collaborators
St. Jude Medical

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT03170583     History of Changes
Other Study ID Numbers: SJM-CIP- CL1000304
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

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