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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-TactiCath Quartz PAS


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General
Study Status Progress Adequate
Application Number P130026 / PAS001
Date Current Protocol Accepted 08/20/2014
Study Name OSB Lead-TactiCath Quartz 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, non-randomized, multicenter, cohort

study which will combine new enrollments with patients currently enrolled in the TOCCASTAR supplemental IDE study (G100230/S014) and/or CAP study (G100230/S020) that are still active in the follow-up phase.

Sample Size A target of approximately 175 patients will be enrolled from

35 sites in the United States.



For the safety endpoint, a performance goal of 16.2% is proposed, equal to the rate of 8.1% plus a margin of 8.1%. Based on this performance goal, with a one-sided 0.05 alpha level, a total of 175 subjects would provide greater than 95% power for this endpoint on a one sample exact test of binomial proportions.



For the efficacy endpoint, a performance goal of 54.9% is proposed, equal to the lower quartile 64.9% minus a 10% margin. Based on this performance goal, with a one-sided

0.05 alpha level, a total of 175 subjects would provide approximately 80% power for an assumed event rate of 64.9% on a one sample exact test of binomial proportions.

Data Collection performance goal of 54.9%. Procedural failure is defined by

the occurrence of any of the following events:

1. Documentation of recurrence of AF/AFL/AT episodes during the 9-month observational period lasting longer than 30 seconds

2. Repeat ablation following the blanking period

3. Use of a new antiarrhythmic drug (AAD) following the blanking period (use of a previously ineffective drug does not constitute treatment failure)



Secondary endpoints

1. Recurrence of symptomatic AF at 5 years

2. Number of repeat ablations (incidence and time from index procedure)

3. Use of antiarrhythmic drugs

Primary endpoints

Safety

The rate of device or procedure related serious adverse events occurring within 7 days of the index procedure or hospital discharge, whichever is later, is lower than a performance goal of 16.2%.



Effectiveness

The rate of subjects free from symptomatic paroxysmal atrial fibrillation (PAF), atrial flutter (AFL), and atrial tachycardia (AT) lasting longer than 30 seconds through 9 months of follow-up after a 3-month blanking period is higher than a



4. Long-term (5 year) occurrence of Serious Adverse

Events (SAEs)

5. Device malfunction

Follow-up Visits and Length of Follow-up Duration of Study Participation:

Enrollment period: 18 months.

Patients will be evaluated at pre discharge, at 7 days, at 3, 6 and 12 months post index procedure and then yearly thereafter through 60 months.

After the index procedure, patients will be followed for a total of 60 months.

Total Study Duration: Up to 78 months



OSB Lead-TactiCath Quartz PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 04/24/2015 04/24/2015 On Time
one year report 10/24/2015 10/23/2015 On Time
18 month report 04/23/2016 04/21/2016 On Time
two year report 10/23/2016 10/18/2016 On Time
three year report 10/23/2017 10/24/2017 Overdue/Received
four year report 10/23/2018    
five year report 10/23/2019    


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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