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

Cryptogenic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00465270
• Other study ID #: AGA-006
• Secondary ID: G990318
• Status: Completed
• Phase: N/A
• Start date: August 2003
• Est. completion date: May 2016

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 980
• Est. completion date: May 2016
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cryptogenic Stroke
• Foramen Ovale, Patent
• Stroke

Intervention

Device:
• AMPLATZER PFO Occluder
patent foramen ovale closure device

Other:
• Standard of Care - Medical Management
Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	Stroke Prevention & Atherosclerosis Research Center (SPARC) - Robarts Research Institute	London	Ontario
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Royal Columbian Hospital	New Westminster	British Columbia
Canada	Toronto General Hospital	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
United States	Neurology and Neuroscience Associates	Akron	Ohio
United States	Albany Medical Center	Albany	New York
United States	LeHigh Valley Hospital	Allentown	Pennsylvania
United States	DENT Neurologic Institute	Amherst	New York
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	University of Alabama	Birmingham	Alabama
United States	Tufts Medical Center	Boston	Massachusetts
United States	Charleston Area Medical Center	Charleston	West Virginia
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Our Lady of Lourdes Medical Center	Cherry Hill	New Jersey
United States	Northwestern University	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	UT Southwestern Medical School	Dallas	Texas
United States	University of Colorado	Denver	Colorado
United States	Ruan Neurology	Des Moines	Iowa
United States	St. Mary's Duluth Clinic	Duluth	Minnesota
United States	Duke University Medical Center	Durham	North Carolina
United States	Moses H. Cone Memorial Hospital	Greensboro	North Carolina
United States	Penn State Milton South Hershey Medical Center	Hershey	Pennsylvania
United States	University of Texas Houston Health Science Center	Houston	Texas
United States	Indiana Heart Physicians	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	St. Vincent's Medical Center	Jacksonville	Florida
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	St. Mary's Medical Center	Langhorne	Pennsylvania
United States	University of Kentucky	Lexington	Kentucky
United States	South Denver Cardiology Associates	Littleton	Colorado
United States	LAC + USC Medical Center	Los Angeles	California
United States	UCLA	Los Angeles	California
United States	Medical Center of the Rockies	Loveland	Colorado
United States	University of Wisconsin Hospital	Madison	Wisconsin
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	University of Minnesota	Minneapolis	Minnesota
United States	St. Thomas Neurology	Nashville	Tennessee
United States	Vanderbilt University	Nashville	Tennessee
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	University of Medicine and Dentistry of New Jersy	Newark	New Jersey
United States	Summit Medical Center	Oakland	California
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Neurologic Associates Inc	Palos Heights	Illinois
United States	OSF St. Francis Medical Center	Peoria	Illinois
United States	Oregon Stroke Center, OHSU	Portland	Oregon
United States	Providence St. Vincent's Medical Center	Portland	Oregon
United States	University of Rochester	Rochester	New York
United States	Washington University	Saint Louis	Missouri
United States	Methodist Hospital/Park Nicollet Medical Center	Saint Louis Park	Minnesota
United States	Sharp Memorial Hospital	San Diego	California
United States	Kaiser Permanente	San Francisco	California
United States	Mayo Clinic	Scottsdale	Arizona
United States	UW Medicine Stroke Center	Seattle	Washington
United States	North Central Heart Institute	Sioux Falls	South Dakota
United States	Southern Illinois University Neurology	Springfield	Illinois
United States	Midatlantic Cardiovascular Associates	Towson	Maryland
United States	Sentara Virginia Beach General Hospital	Virginia Beach	Virginia
United States	George Washington University Hospital	Washington	District of Columbia
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	Rate of Complete PFO Closure (Assessed by TEE Bubble Study) at the 6-month Follow-up in the Device Group		6 months

External Links

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