SJM Brady MRI Post Approval Study (Brady MRI PAS)

• ClinicalTrials.gov Identifier: NCT03170583
• Recruitment Status: Terminated
• First Posted: May 31, 2017
• Last Update Posted: July 28, 2020
• Sponsor: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

Tracking Information

• First Submitted Date: May 26, 2017
• First Posted Date: May 31, 2017
• Last Update Posted Date: July 28, 2020
• Actual Study Start Date: June 8, 2017
• Actual Primary Completion Date: June 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 26, 2017)

• 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 ]

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: May 26, 2017): The complication rate of the Tendril MRI lead [ Time Frame: 60 months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: SJM Brady MRI Post Approval Study
• Official Title: SJM Brady MRI Post Approval Study
• 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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Patients with a standard bradycardia indication.
• Condition: Bradycardia

Intervention

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

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: July 24, 2020): 1768
• Original Estimated Enrollment (submitted: May 26, 2017): 1756
• Actual Study Completion Date: June 30, 2020
• Actual Primary Completion Date: June 30, 2020 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03170583
• Other Study ID Numbers: SJM-CIP- CL1000304
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Abbott Medical Devices
• Original Responsible Party: Same as current
• Current Study Sponsor: Abbott Medical Devices
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Abbott Medical Devices
• Verification Date: July 2020