Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial

Abbott Medical Devices980 enrolled

Overview

The purpose of this study is to investigate whether percutaneous Patent Foramen Ovale (PFO) closure, using the AMPLATZER PFO Occluder, is superior to current standard of care medical treatment in the prevention of recurrent embolic stroke.

The AMPLATZER PFO Occluder is a percutaneous, transcatheter occlusion device intended for the non-surgical closure of patent foramen ovale in subjects who have had a cryptogenic stroke due to presumed paradoxical embolism within the last 270 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

980

Conditions

Cryptogenic Stroke

Interventions

AMPLATZER PFO OccluderDEVICE

patent foramen ovale closure device

Standard of Care - Medical ManagementOTHER

Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who have had a cryptogenic stroke within the last 270 days * Subjects who have been diagnosed with a Patent Foramen Ovale (PFO) * Subjects willing to participate in follow-up visits Exclusion Criteria: * Subjects with intracardiac thrombus or tumor * Subjects who have an acute or recent (within 6 months) myocardial infarction or unstable angina * Subjects with left ventricular aneurysm or akinesis * Subjects with atrial fibrillation/atrial flutter (chronic or intermittent) * Subjects with another source of right to left shunt identified at baseline, including an atrial septal defect and/or fenestrated septum * Subjects with contraindication to aspirin or Clopidogrel therapy * Pregnant or desire to become pregnant within the next year

Locations (69)

Outcomes

Primary Outcomes

Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization

Nonfatal stroke is defined as: 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 imaging findings of a new, neuroanatomically relevent, cergral infarct. Post-randomization death is defined as: in the MM group as all-cause mortality within 45 days after randomization, and in the device group as all-cause mortality 30 days after implant or 45 days after randomizaiton, whichever occurs last.

Time frame: Trial enrollment was stopped once 25 unique subjects were mutually adjudicated by the CEC and DSMB as having experienced a primary endpoint event. This occurred on December 20, 2011. The mean follow-up time was 2.6 years.

Secondary Outcomes

Rate of Complete PFO Closure (Assessed by TEE Bubble Study) at the 6-month Follow-up in the Device Group

Time frame: 6 months

Data from ClinicalTrials.gov

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