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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-SJM Brady MRI PAS


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General
Study Status Progress Adequate
Application Number P140033 / PAS001
Date Current Protocol Accepted  
Study Name OSB Lead-SJM Brady MRI PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, multi-center clinical study designed to evaluate the long-term safety and lead performance of the Tendril MRI lead implanted with any SJM Brady MRI IPG or similar model in subjects with a standard bradycardia pacing indication. The minimum enrollment requirement for completing this study is 1756 subjects including Accent MRI IDE study roll over subjects. A maximum of 175 (10% of the total) enrollments will be allowed per center. The study will evaluate long-term lead safety of the Tendril MRI lead at 60 months with study evaluations occurring every six (6) months following enrollment. To 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 the MRI scan visit procedures if they are scheduled for or planning to have a MRI scan during the course of the study. Patients implanted with the SJM Brady MRI System commercially may also participate in the MRI Scan visit procedures once enrolled by signing the MRI Scan Visit Informed Consent. The total anticipated duration of this study is approximately 94 months including enrollment of 34 months.
Study Population Description Subjects who meet the Lead Safety Arm and/or MRI Scan Arm specific inclusion/exclusion criteria, sign the appropriate IRB approved informed consents for the arm they are enrolling in (when applicable), and have an implanted Tendril MRI lead or attempted implant of the Tendril MRI lead will be considered enrolled in the study under that specific arm.
Sample Size Approximately 1756 subjects will be enrolled in the study at approximately 70 centers in and outside of the US (<50%). Assuming the time to first Tendril MRI RV/RA lead related complication follows an exponential distribution and a conservative RV/RA lead-related complication free rate of 95% at 60 months, a study size of 641 Tendril MRI RV leads provides 80% of power to reject the null hypothesis at the 0.05 significance level. The individual lead related complication rate at 60 months is expected to be 0.3% or smaller. The sample size required to obtain a 97.5% upper confidence bound (UCB) for a complication rate of no more than 1%, based on the Clopper-Pearson exact Binomial method, assuming an expected complication rate of 0.3%, is 753 subjects. With an expected attrition at 5 years of 49.5%, a total of 1492 (=753/0.505) Tendril MRI™ RA leads are required in the study. Since 85% of the enrolled subjects are expected to be implanted with a dual chamber pacemaker, a total of 1756 (=1492/0.85) subjects with Tendril MRI RV leads are expected to be enrolled in the study. This will provide at least 753 subjects with both Tendril MRI RA and Tendril MRI RV leads with 5-years of follow-up. The number of MRI scans captured in the MRI Scan Arm will be largely dependent on whether or not SJM Brady MRI system implanted subjects are scheduled for a clinically indicated MRI scan at any point during the study. Every clinically indicated MRI scan that is ordered for SJM Brady MRI system implanted subjects may be captured in the MRI Scan arm.
Data Collection Primary Outcome Measures • Freedom from Tendril MRI RA lead-related complications through 60 months of follow up • Freedom from Tendril MRI RV lead-related complications through 60 months of follow up • MRI scan related complications rate through one-month following the MRI scan Secondary Outcome Measures • Complication rate of the Tendril MRI™ RA and Tendril MRI™ RV Lead

Additional Data

Demographics: gender, age, ethnicity, race, cardiac disease history, arrhythmia history, indication for pacemaker implant, history of smoking, etc.

Atrial and ventricular lead impedance through the 60 month visit

Atrial and ventricular capture thresholds through the 60 month visit

Atrial and ventricular sensing amplitudes through the 60 month visit

System-related complications through the 60 month visit

Individual complications through the 60 month visit

Mortality

MRI system and scan conditions collected at time of MRI

Atrial and ventricular capture thresholds through 1 month post MRI visit

Data source: new enrolled patients and rollover IDE patients
Follow-up Visits and Length of Follow-up 60 months


OSB Lead-SJM Brady MRI PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/01/2017 08/01/2017 On Time
one year report 01/31/2018    
18 month report 08/01/2018    
two year report 01/31/2019    
three year report 01/31/2020    
four year report 01/30/2021    
five year report 01/30/2022    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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