Clinical trial NCT00465270: Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial
Official title: Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cryptogenic Stroke
Keywords: Cryptogenic
Stroke
PFO
Patent foramen ovale
AMPLATZER
Occluder
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2007-04-24
Enrollment: 980
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: AMPLATZER PFO Occluder
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization
timeFrame: 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:
measure: Rate of Complete PFO Closure (Assessed by TEE Bubble Study) at the 6-month Follow-up in the Device Group
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Los Angeles
country: United States
facility: LAC + USC Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Oakland
country: United States
facility: Summit Medical Center
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente
state: California
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Littleton
country: United States
facility: South Denver Cardiology Associates
state: Colorado
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Washington
country: United States
facility: George Washington University Hospital
state: District of Columbia
city: Jacksonville
country: United States
facility: St. Vincent's Medical Center
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Palos Heights
country: United States
facility: Neurologic Associates Inc
state: Illinois
city: Peoria
country: United States
facility: OSF St. Francis Medical Center
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University Neurology
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Heart Physicians
state: Indiana
city: Des Moines
country: United States
facility: Ruan Neurology
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Towson
country: United States
facility: Midatlantic Cardiovascular Associates
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Duluth
country: United States
facility: St. Mary's Duluth Clinic
state: Minnesota
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Louis Park
country: United States
facility: Methodist Hospital/Park Nicollet Medical Center
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Cherry Hill
country: United States
facility: Our Lady of Lourdes Medical Center
state: New Jersey
city: Newark
country: United States
facility: University of Medicine and Dentistry of New Jersy
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Amherst
country: United States
facility: DENT Neurologic Institute
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: Moses H. Cone Memorial Hospital
state: North Carolina
city: Akron
country: United States
facility: Neurology and Neuroscience Associates
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: Providence St. Vincent's Medical Center
state: Oregon
city: Portland
country: United States
facility: Oregon Stroke Center, OHSU
state: Oregon
city: Allentown
country: United States
facility: LeHigh Valley Hospital
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton South Hershey Medical Center
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Langhorne
country: United States
facility: St. Mary's Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Sioux Falls
country: United States
facility: North Central Heart Institute
state: South Dakota
city: Nashville
country: United States
facility: St. Thomas Neurology
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical School
state: Texas
city: Houston
country: United States
facility: University of Texas Houston Health Science Center
state: Texas
city: Virginia Beach
country: United States
facility: Sentara Virginia Beach General Hospital
state: Virginia
city: Seattle
country: United States
facility: UW Medicine Stroke Center
state: Washington
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
city: Madison
country: United States
facility: University of Wisconsin Hospital
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: London
country: Canada
facility: Stroke Prevention & Atherosclerosis Research Center (SPARC) - Robarts Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: UCLA Stroke Center
name: Jeffrey Saver, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: John D Carroll, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Houston Health Science Center
name: Richard Smalling, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tufts Medical Center
name: David Thaler, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.