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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-PCT Change Study


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General
Study Status Progress Adequate
Application Number P980035 S442/ PAS001
Date Current Protocol Accepted  
Study Name OSB Lead-PCT Change Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study will be conducted within Medtronic’s Product Surveillance Registry (PSR). The PSR platform is designed to conduct non-randomized, active,

prospective post-market surveillance. Patients implanted with a MR Conditional CIED system and enrolled in the PSR will be followed per the expected standard of care practice of their care provider. Pacing capture thresholds (PCT) measurements of MR conditional CIED systems enrolled in the PSR will be used to prospectively monitor changes in PCT following 3T MR exposure. Patient status is collected approximately every 6 to 12 months including MRI scan information, if applicable. Sites will report patient baseline information (e.g. height, weight, etc.) the occurrence of a medically indicated MRI scan, reason for scan, anatomical region scanned, magnet strength, and MRI related events.

Analysis of the primary objective will be performed 4-years following approval
Study Population Description All patients implanted with a MR Conditional CIED system and enrolled in the PSR who subsequently receive an MRI scan using a 3T system within the 4-years post approval that meets approved labelling requirements.
Sample Size The following assumptions were used to estimate the PAS duration and number of 3T scans projected to be obtained during the 4-years study period:

MR Conditional CIED enrollment of approximately 2,400 patients

Annual MRI scan rate of 9%

Participating sites with 3T scanning capability: 25% - 40%

% of patients with a 3T MRI scan: 30% - 45%

Table 3: 3T Scan Rate Assumptions Over 4-Year Study Duration

Assumptions Year 1 Year 2 Year 3 Year 4

Cumulative MR Conditional Enrollments (*) 1260 1674 2047 2382

Cumulative # of completed MRI Scans 113 264 450 571

Assumption for % centers with 3T capability 25% 25% to 40%

% MR scans through 3T in these centers 30% 30% - 45%

Cumulative # of completed 3T scans 9 43 to 103

(*) Assumes a 10% annual attrition

Contribution from enrollments outside the US to the primary objective will be

limited to no more than 50% of the total sample size.
Data Collection Primary Endpoints:

To characterize the proportion of patients implanted with an MR conditional CEID system with a pre to post MRI scan PCT measure change of more than 0.5 V following 3T scan exposure.

Definitions for pre and post PCT measurements

Pre-MRI PCT measure: max PCT value preceding the SureScan mode

enabled and prior to the 3T MRI scan

Post-MRI PCT measure: 1st max PCT measurement at a time point >30

days (chronic PCT) following 3T MRI exposure.

Further investigation will be carried out to identify root cause if the observed proportion of PCT changes following 3T scan exposure is greater than 8% (i.e. 2X the observed proportion in the PSR SureScan data) and more than 50% of those observed >0.5V PCT changes reflect an increase.
Follow-up Visits and Length of Follow-up 4 years post-approval


OSB Lead-PCT Change Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/27/2016 10/27/2016 On Time
one year report 04/28/2017 04/27/2017 On Time
18 month report 10/27/2017 10/26/2017 On Time


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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