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

January 31, 2019 updated by: Abbott Medical Devices

Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

980

Phase

  • Not Applicable

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • University of Calgary
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W5
        • Royal Columbian Hospital
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
      • Vancouver, British Columbia, Canada, V5Z 1Y6
        • St. Paul's Hospital
    • Ontario
      • London, Ontario, Canada, N6G 2V2
        • Stroke Prevention & Atherosclerosis Research Center (SPARC) - Robarts Research Institute
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic
    • California
      • Los Angeles, California, United States, 90095
        • UCLA
      • Los Angeles, California, United States, 90033
        • LAC + USC Medical Center
      • Oakland, California, United States, 94609
        • Summit Medical Center
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
      • San Francisco, California, United States, 94115
        • Kaiser Permanente
    • Colorado
      • Denver, Colorado, United States, 80262
        • University of Colorado
      • Littleton, Colorado, United States, 80120
        • South Denver Cardiology Associates
      • Loveland, Colorado, United States, 80538
        • Medical Center of the Rockies
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
      • Washington, District of Columbia, United States, 20037
        • George Washington University Hospital
    • Florida
      • Jacksonville, Florida, United States, 32204
        • St. Vincent's Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago
      • Chicago, Illinois, United States, 60611-3078
        • Northwestern University
      • Palos Heights, Illinois, United States, 60463
        • Neurologic Associates Inc
      • Peoria, Illinois, United States, 61637
        • OSF St. Francis Medical Center
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University Neurology
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Indiana Heart Physicians
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Ruan Neurology
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Kansas University Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University Of Kentucky
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Towson, Maryland, United States, 21014
        • Midatlantic Cardiovascular Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0316
        • University of Michigan Health System
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • St. Mary's Duluth Clinic
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hospital
      • Saint Louis Park, Minnesota, United States, 55426
        • Methodist Hospital/Park Nicollet Medical Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • Nebraska
      • Omaha, Nebraska, United States, 68198-2045
        • University of Nebraska Medical Center
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08034
        • Our Lady of Lourdes Medical Center
      • Newark, New Jersey, United States, 07103
        • University of Medicine and Dentistry of New Jersy
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
      • Amherst, New York, United States, 14226
        • Dent Neurologic Institute
      • Rochester, New York, United States, 14642
        • University of Rochester
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Greensboro, North Carolina, United States, 27410
        • Moses H. Cone Memorial Hospital
    • Ohio
      • Akron, Ohio, United States, 44320
        • Neurology and Neuroscience Associates
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97225
        • Providence St. Vincent's Medical Center
      • Portland, Oregon, United States, 97329
        • Oregon Stroke Center, OHSU
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18105
        • Lehigh Valley Hospital
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton South Hershey Medical Center
      • Lancaster, Pennsylvania, United States, 17543
        • Lancaster General Hospital
      • Langhorne, Pennsylvania, United States, 19067
        • St. Mary's Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • North Central Heart Institute
    • Tennessee
      • Nashville, Tennessee, United States, 37232-8802
        • Vanderbilt University
      • Nashville, Tennessee, United States, 37205
        • St. Thomas Neurology
    • Texas
      • Dallas, Texas, United States, 75390-8897
        • UT Southwestern Medical School
      • Houston, Texas, United States, 77030
        • University of Texas Houston Health Science Center
    • Virginia
      • Virginia Beach, Virginia, United States, 23454
        • Sentara Virginia Beach General Hospital
    • Washington
      • Seattle, Washington, United States, 98104
        • UW Medicine Stroke Center
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Charleston Area Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University Of Wisconsin Hospital
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Device
AMPLATZER PFO Occluder
Device: AMPLATZER PFO Occluder
patent foramen ovale closure device
Active Comparator: Standard or Care - Medical Management
Medical treatment with Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole.
Other: Standard of Care - Medical Management
Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization
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.

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.
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 Outcome Measures

Outcome Measure
Time Frame
Rate of Complete PFO Closure (Assessed by TEE Bubble Study) at the 6-month Follow-up in the Device Group
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Jeffrey Saver, MD, UCLA Stroke Center
  • Principal Investigator: John D Carroll, MD, University of Colorado, Denver
  • Principal Investigator: Richard Smalling, MD, University of Texas Houston Health Science Center
  • Principal Investigator: David Thaler, MD, Tufts Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2003

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

April 23, 2007

First Submitted That Met QC Criteria

April 23, 2007

First Posted (Estimate)

April 24, 2007

Study Record Updates

Last Update Posted (Actual)

February 18, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGA-006
  • G990318

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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