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History of Changes for Study: NCT03170583
SJM Brady MRI Post Approval Study (Brady MRI PAS)
Latest version (submitted July 24, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 26, 2017 None (earliest Version on record)
2 July 6, 2017 Recruitment Status, Study Status and Contacts/Locations
3 September 29, 2017 Study Status and Contacts/Locations
4 April 13, 2018 Contacts/Locations and Study Status
5 April 26, 2019 Recruitment Status, Study Status, Contacts/Locations, Study Description, Oversight and Study Identification
6 July 24, 2020 Recruitment Status, Study Status and Study Design
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Study NCT03170583
Submitted Date:  May 26, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: SJM-CIP- CL1000304
Brief Title: SJM Brady MRI Post Approval Study (Brady MRI PAS)
Official Title: SJM Brady MRI Post Approval Study
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2017
Overall Status: Not yet recruiting
Study Start: July 1, 2017
Primary Completion: August 1, 2025 [Anticipated]
Study Completion: September 1, 2025 [Anticipated]
First Submitted: May 26, 2017
First Submitted that
Met QC Criteria:
May 26, 2017
First Posted: May 31, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
May 26, 2017
Last Update Posted: May 31, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Abbott Medical Devices
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device: Yes
Pediatric Postmarket Surveillance:
Data Monitoring: No
Open or close this module Study Description
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.

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.

Open or close this module Conditions
Conditions: Bradycardia
Keywords: bradycardia, pacemaker, MRI scan
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 1756 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
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
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Study Population: Patients with a standard bradycardia indication.
Sampling Method: Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: Nikesha N Harrington, BA
Telephone: 972-426-4813
Email: nharrington03@sjm.com
Central Contact Backup: Grant Kim, MS
Telephone: 818-493-3147
Email: gkim@sjm.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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