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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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Amplatzer PFO Occluder New Enrollment PAS


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General
Study Status Progress Adequate
Application Number P120021 / PAS001
Date Current Protocol Accepted 05/23/2019
Study Name 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 This is a single arm, multi-center, prospective, new enrollment study.

The objectives of this study are the following:

(1) To demonstrate safety of the AMPLATZER PFO Occluder by assessing the short-term (30-day) rate of device- or procedure-related serious adverse

events (including those that led to death)

(2) To demonstrate that the AMPLATZER 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
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 547 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

Training effectiveness - will be summarized by reporting the procedure-related SAE rate for new operators





Follow-up Visits and Length of Follow-up Subjects will be followed for 5 years post implant.
Interim or Final Data Summary
Interim Safety Information Primary Safety Endpoint: The Safety hypothesis will be assessed once all eligible subjects have met 30-day follow-up. As of this report, 10 subjects have had a Serious Adverse Event (atrial fibrillation) that counts towards the primary safety endpoint.

Primary Effectiveness Endpoint: The Effectiveness hypothesis will be assessed once all eligible subjects have completed 5-year follow-up. As of this report, three subjects had an event that was adjudicated as an Ischemic Stroke. These events will count towards the primary effectiveness endpoint.

Serious Adverse Events: 73 events have been adjudicated as Serious Adverse Events, 26 of these were adjudicated as device-related. The device-related events were atrial fibrillation (n=10), atrial flutter (n=2), non-cardiac chest pain (n=1), chest pain (n=1), device embolization (n=1), ischemic stroke (n=2), migraine (n=1), paroxysmal supraventricular tachycardia (n=1), pulmonary embolism (n=4), Reintervention for Residual Shunt/device Removal (n=1), thrombus on device (n=1), and transient ischemic attack (n=1).
Actual Number of Patients Enrolled Subject enrollment is ongoing. 563 Subjects are enrolled. Subject enrollment is approximately 46% (563/1214) complete
Actual Number of Sites Enrolled Site enrollment is ongoing. 87 Sites have IRB approval and are activated, and 75 Sites are enrolling subjects. Site enrollment is 87% (87/100) complete.
Patient Follow-up Rate Subject follow-up is ongoing. The reported follow-up rate is currently 96% at the 1-month study visit, 87% at the 6-month study visit, 82% at the 12-month study visit, and 73% at the 24-month visit. Approximately one third of currently enrolled subjects have met the 2-year visit time point, but few have reached the 3-year visit time-point.
Study Strengths & Weaknesses Not yet applicable


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 04/27/2018 On Time
two year report 10/28/2018 10/26/2018 On Time
interim report 04/26/2019 04/26/2019 On Time
three year report 10/28/2019 10/25/2019 On Time
42 month report 04/27/2020 04/27/2020 On Time
four year report 10/28/2020 10/28/2020 On Time
54 month report 04/27/2021 04/27/2021 On Time
five year report 10/27/2021    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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