• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail
-

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.

Learn more...


             

OSB Lead-Amplatzer PFO Occluder New Enrollment PAS


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Study Pending
Application Number P120021 / PAS001
Date Current Protocol Accepted  
Study Name OSB Lead-Amplatzer PFO Occluder New Enrollment 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 Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description (1) To demonstrate safety of the AMPLATZER PFO Occluder by assessing the 30-day rate of device- or procedure-related serious adverse events including those that led to death

(2) To demonstrate that the AMPLATZERTM PFO Occluder is effective by assessing the rate of recurrent ischemic stroke through 5 years

(3) To demonstrate effectiveness of the training program for new operators

This study is a single arm, multi-center prospective study.

Study Population Description Patients over the age of 18 years and less than 60 years who have experienced a cryptogenic stroke diagnosed by a neurologist in the 270 days prior to consent and have a patent foramen ovale diagnosed by transesophageal echocardiogram.

Sample Size The overall sample size for this trial is 1214 subjects, which is driven by the primary effectiveness endpoint. The overall sample size accounts for 25% attrition over 5 years. To ensure that enrollment is balanced across sites, no investigational site will be allowed to enroll more than 20% of the maximum sample size (242 subjects).



The sample size is estimated to have adequate power to test the primary effectiveness endpoint. The assumed primary effectiveness endpoint event rate is 2.2% and the performance goal is 3.9%. Using a one-sided 2.5% significance level, 910 subjects are required to have 80% power to reject the null hypothesis with the exact binomial method. Assuming 25% attrition over 5 years, a total of 1214 subjects is required.



The sample size is estimated to have adequate power to test the primary safety endpoint. The assumed primary safety endpoint event rate is 2.07% and the performance goal is 4.14%. Using a one- sided 2.5% significance level, 653 subjects are required to obtain 80% power to reject the null hypothesis with the exact binomial method. Due to the acute nature of this endpoint, no attrition is assumed.

Data Collection Primary Safety: Device- or procedure-related serious adverse events (as adjudicated by a Clinical Events Committee) through 30 days, including:

Atrial Fibrillation

Pulmonary Embolism

Deep Vein Thrombosis

Device Thrombus

Device Erosion

Device Embolization

Ischemic stroke if subject was not successfully implanted with a device

Hemorrhagic Stroke

Major Bleeding requiring transfusion, or surgical or endovascular intervention

Vascular Access Site Complication requiring surgical intervention

Device- or Procedure-Related Serious Adverse Event leading to death



Primary Effectiveness: 5-year rate of recurrent ischemic stroke

Ischemic stroke is defined as acute focal neurological deficit presumed to be due to focal ischemia, and either 1) symptoms persisting 24 hours or greater, or 2) symptoms persisting less than 24 hours but associated with MR or CT findings of a new, neuroanatomically relevant, cerebral infarct.

Descriptive Endpoints:

Rate of stroke of unknown cause (determined by ASCOD adjudication) through each annual follow-up

Rate of Transient Ischemic Attack (TIA)1 through each annual follow-up

Rate of atrial fibrillation through each annual follow-up

Rate of pulmonary embolism through each annual follow-up – the rate will be descriptively compared to the rates observed in the randomized groups in the RESPECT investigational device exemption (IDE) trial

Rate of deep vein thrombosis through each annual follow-up – the rate will be descriptively compared to the rate observed in the randomized groups in the RESPECT IDE trial

Rate of venous thromboembolism events (DVT or PE) through each annual follow-up – the rate will be descriptively compared to the rate observed in the randomized groups in the RESPECT IDE trial

Rate of device thrombus through each annual follow-up

Rate of device erosion through each annual follow-up

Rate of device embolization through each annual follow-up



Rate of ischemic stroke through each annual follow-up

Rate of hemorrhagic stroke through each annual follow-up

Rate of atrial flutter through each annual follow-up

Rate of paroxysmal supraventricular tachycardia requiring treatment through each annual follow-up

Antithrombotic medication (single antiplatelet, dual antiplatelet, warfarin, novel oral anticoagulant, other) use at each follow-up

SF-12 quality of life physical and mental component score at baseline, 1 month, 6 months and 1 year

Health state utility values from EQ-5D at baseline, 1 month, 6 months and 1 year

Effective closure – Grade 0 or 1 maximal shunt through the PFO at rest and/or Valsalva as assessed by transthoracic echocardiogram (TTE) or transesophageal echocardiogram (TEE) at 1 year

Complete closure – Grade 0 maximal shunt through the PFO at rest and/or Valsalva as assessed by TTE or TEE at 1 year

Technical success – Successful delivery and release of the AMPLATZER PFO Occluder for subjects in whom the delivery system entered the body

Procedural success – Successful implantation of the AMPLATZER PFO Occluder with no reported in-hospital serious adverse events (SAEs) for subjects in whom the delivery system entered the body



1TIA is defined as acute focal neurological deficit (defined as focal motor deficit, aphasia, difficulty walking, hemisensory deficit, amaurosis fugax, blindness, or focal visual deficit) presumed due to focal ischemia with symptoms persisting greater than or equal to 5 minutes and less

than 24 hours, that are not associated with MR or CT findings of a new neuroanatomically relevant cerebral infarct.

Follow-up Visits and Length of Follow-up Subjects will be followed for 5 years post implant.


OSB Lead-Amplatzer PFO Occluder New Enrollment PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 04/28/2017 05/11/2017 Overdue/Received
one year report 10/28/2017 10/26/2017 On Time
18 month report 04/28/2018    
two year report 10/28/2018    
three year report 10/28/2019    
four year report 10/27/2020    
five year report 10/27/2021    


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

Related Links

-
-