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
|Condition or disease||Intervention/treatment|
|Bradycardia||Device: St. Jude Medical Tendril MRI™ lead|
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|
|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|
- Device: St. Jude Medical Tendril MRI™ lead
pacemaker, leadsOther Names:
- St. Jude Medical Accent MRI™ pacemaker
- St. Jude Medical Assurity MRI™ pacemaker
- St. Jude Medical Endurity MRI™pacemaker
- 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 ]
- The complication rate of the Tendril MRI lead [ Time Frame: 60 months ]
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
|Contact: Nikesha N Harrington, BAemail@example.com|
|Contact: Grant Kim, MSfirstname.lastname@example.org|
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