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

• ClinicalTrials.gov Identifier: NCT00465270
• Recruitment Status: Completed
• First Posted: April 24, 2007
• Results First Posted: September 4, 2018
• Last Update Posted: February 18, 2019
• Sponsor: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Cryptogenic Stroke	Device: AMPLATZER PFO Occluder; Other: Standard of Care - Medical Management	Not Applicable

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 980 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: AMPLATZER PFO Occluder
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT)
• Actual Study Start Date: August 2003
• Actual Primary Completion Date: May 2012
• Actual Study Completion Date: May 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Alabama

University of Alabama

Birmingham, Alabama, United States, 35249

United States, Arizona

Mayo Clinic

Scottsdale, Arizona, United States, 85259

United States, California

LAC + USC Medical Center

Los Angeles, California, United States, 90033

UCLA

Los Angeles, California, United States, 90095

Summit Medical Center

Oakland, California, United States, 94609

Sharp Memorial Hospital

San Diego, California, United States, 92123

Kaiser Permanente

San Francisco, California, United States, 94115

United States, Colorado

University of Colorado

Denver, Colorado, United States, 80262

South Denver Cardiology Associates

Littleton, Colorado, United States, 80120

Medical Center of the Rockies

Loveland, Colorado, United States, 80538

United States, District of Columbia

Washington Hospital Center

Washington, District of Columbia, United States, 20010

George Washington University Hospital

Washington, District of Columbia, United States, 20037

United States, Florida

St. Vincent's Medical Center

Jacksonville, Florida, United States, 32204

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611-3078

University of Chicago

Chicago, Illinois, United States, 60637-1470

Neurologic Associates Inc

Palos Heights, Illinois, United States, 60463

OSF St. Francis Medical Center

Peoria, Illinois, United States, 61637

Southern Illinois University Neurology

Springfield, Illinois, United States, 62702

United States, Indiana

Indiana Heart Physicians

Indianapolis, Indiana, United States, 46237

United States, Iowa

Ruan Neurology

Des Moines, Iowa, United States, 50314

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States, 52242

United States, Kansas

Kansas University Medical Center

Kansas City, Kansas, United States, 66160

United States, Kentucky

University of Kentucky

Lexington, Kentucky, United States, 40536

United States, Louisiana

Ochsner Clinic Foundation

New Orleans, Louisiana, United States, 70121

United States, Maryland

Midatlantic Cardiovascular Associates

Towson, Maryland, United States, 21014

United States, Massachusetts

Tufts Medical Center

Boston, Massachusetts, United States, 02111

United States, Michigan

University of Michigan Health System

Ann Arbor, Michigan, United States, 48109-0316

United States, Minnesota

St. Mary's Duluth Clinic

Duluth, Minnesota, United States, 55805

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States, 55407

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Methodist Hospital/Park Nicollet Medical Center

Saint Louis Park, Minnesota, United States, 55426

United States, Missouri

Washington University

Saint Louis, Missouri, United States, 63110

United States, Nebraska

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198-2045

United States, New Jersey

Our Lady of Lourdes Medical Center

Cherry Hill, New Jersey, United States, 08034

University of Medicine and Dentistry of New Jersy

Newark, New Jersey, United States, 07103

United States, New York

Albany Medical Center

Albany, New York, United States, 12208

DENT Neurologic Institute

Amherst, New York, United States, 14226

University of Rochester

Rochester, New York, United States, 14642

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710

Moses H. Cone Memorial Hospital

Greensboro, North Carolina, United States, 27410

United States, Ohio

Neurology and Neuroscience Associates

Akron, Ohio, United States, 44320

University Hospitals of Cleveland

Cleveland, Ohio, United States, 44106

Ohio State University

Columbus, Ohio, United States, 43210

United States, Oregon

Providence St. Vincent's Medical Center

Portland, Oregon, United States, 97225

Oregon Stroke Center, OHSU

Portland, Oregon, United States, 97329

United States, Pennsylvania

LeHigh Valley Hospital

Allentown, Pennsylvania, United States, 18105

Penn State Milton South Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

Lancaster General Hospital

Lancaster, Pennsylvania, United States, 17543

St. Mary's Medical Center

Langhorne, Pennsylvania, United States, 19067

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

United States, South Dakota

North Central Heart Institute

Sioux Falls, South Dakota, United States, 57108

United States, Tennessee

St. Thomas Neurology

Nashville, Tennessee, United States, 37205

Vanderbilt University

Nashville, Tennessee, United States, 37232-8802

United States, Texas

UT Southwestern Medical School

Dallas, Texas, United States, 75390-8897

University of Texas Houston Health Science Center

Houston, Texas, United States, 77030

United States, Virginia

Sentara Virginia Beach General Hospital

Virginia Beach, Virginia, United States, 23454

United States, Washington

UW Medicine Stroke Center

Seattle, Washington, United States, 98104

United States, West Virginia

Charleston Area Medical Center

Charleston, West Virginia, United States, 25304

United States, Wisconsin

University of Wisconsin Hospital

Madison, Wisconsin, United States, 53792

Marshfield Clinic

Marshfield, Wisconsin, United States, 54449

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Canada, Alberta

University of Calgary

Calgary, Alberta, Canada, T2N 2T9

University of Alberta

Edmonton, Alberta, Canada, T6G 2B7

Canada, British Columbia

Royal Columbian Hospital

New Westminster, British Columbia, Canada, V3L 3W5

Vancouver General Hospital

Vancouver, British Columbia, Canada, V5Z 1M9

St. Paul's Hospital

Vancouver, British Columbia, Canada, V5Z 1Y6

Canada, Ontario

Stroke Prevention & Atherosclerosis Research Center (SPARC) - Robarts Research Institute

London, Ontario, Canada, N6G 2V2

Toronto General Hospital

Toronto, Ontario, Canada, M5G 2C4

Canada, Quebec

Montreal Heart Institute

Montreal, Quebec, Canada, H1T 1C8

Sponsors and Collaborators

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

More Information

Additional Information:

Related Info 

Publications:

Saver JL, Carroll JD, Thaler DE, Smalling RW, MacDonald LA, Marks DS, Tirschwell DL; RESPECT Investigators. Long-Term Outcomes of Patent Foramen Ovale Closure or Medical Therapy after Stroke. N Engl J Med. 2017 Sep 14;377(11):1022-1032. doi: 10.1056/NEJMoa1610057.

Carroll JD, Saver JL, Thaler DE, Smalling RW, Berry S, MacDonald LA, Marks DS, Tirschwell DL; RESPECT Investigators. Closure of patent foramen ovale versus medical therapy after cryptogenic stroke. N Engl J Med. 2013 Mar 21;368(12):1092-100. doi: 10.1056/NEJMoa1301440.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT00465270
• Other Study ID Numbers: AGA-006; G990318
• First Posted: April 24, 2007
• Results First Posted: September 4, 2018
• Last Update Posted: February 18, 2019
• Last Verified: January 2019

Keywords provided by Abbott Medical Devices:

Cryptogenic; Stroke; PFO; Patent foramen ovale; AMPLATZER; Occluder

Additional relevant MeSH terms:

Stroke; Ischemic Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases