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

Primary Purpose

Cryptogenic Stroke

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
AMPLATZER PFO Occluder
Standard of Care - Medical Management
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cryptogenic Stroke focused on measuring Cryptogenic, Stroke, PFO, Patent foramen ovale, AMPLATZER, Occluder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama
  • Mayo Clinic
  • LAC + USC Medical Center
  • UCLA
  • Summit Medical Center
  • Sharp Memorial Hospital
  • Kaiser Permanente
  • University of Colorado
  • South Denver Cardiology Associates
  • Medical Center of the Rockies
  • Washington Hospital Center
  • George Washington University Hospital
  • St. Vincent's Medical Center
  • Northwestern University
  • University of Chicago
  • Neurologic Associates Inc
  • OSF St. Francis Medical Center
  • Southern Illinois University Neurology
  • Indiana Heart Physicians
  • Ruan Neurology
  • University of Iowa Hospitals and Clinics
  • Kansas University Medical Center
  • University of Kentucky
  • Ochsner Clinic Foundation
  • Midatlantic Cardiovascular Associates
  • Tufts Medical Center
  • University of Michigan Health System
  • St. Mary's Duluth Clinic
  • Abbott Northwestern Hospital
  • University of Minnesota
  • Methodist Hospital/Park Nicollet Medical Center
  • Washington University
  • University of Nebraska Medical Center
  • Our Lady of Lourdes Medical Center
  • University of Medicine and Dentistry of New Jersy
  • Albany Medical Center
  • DENT Neurologic Institute
  • University of Rochester
  • Duke University Medical Center
  • Moses H. Cone Memorial Hospital
  • Neurology and Neuroscience Associates
  • University Hospitals of Cleveland
  • Ohio State University
  • Providence St. Vincent's Medical Center
  • Oregon Stroke Center, OHSU
  • LeHigh Valley Hospital
  • Penn State Milton South Hershey Medical Center
  • Lancaster General Hospital
  • St. Mary's Medical Center
  • Medical University of South Carolina
  • North Central Heart Institute
  • St. Thomas Neurology
  • Vanderbilt University
  • UT Southwestern Medical School
  • University of Texas Houston Health Science Center
  • Sentara Virginia Beach General Hospital
  • UW Medicine Stroke Center
  • Charleston Area Medical Center
  • University of Wisconsin Hospital
  • Marshfield Clinic
  • Medical College of Wisconsin
  • University of Calgary
  • University of Alberta
  • Royal Columbian Hospital
  • Vancouver General Hospital
  • St. Paul's Hospital
  • Stroke Prevention & Atherosclerosis Research Center (SPARC) - Robarts Research Institute
  • Toronto General Hospital
  • Montreal Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Device

Standard or Care - Medical Management

Arm Description

AMPLATZER PFO Occluder

Medical treatment with Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 23, 2007
Last Updated
January 31, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00465270
Brief Title
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 2003 (Actual)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cryptogenic Stroke
Keywords
Cryptogenic, Stroke, PFO, Patent foramen ovale, AMPLATZER, Occluder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
AMPLATZER PFO Occluder
Masking
None (Open Label)
Allocation
Randomized
Enrollment
980 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device
Arm Type
Experimental
Arm Description
AMPLATZER PFO Occluder
Arm Title
Standard or Care - Medical Management
Arm Type
Active Comparator
Arm Description
Medical treatment with Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole.
Intervention Type
Device
Intervention Name(s)
AMPLATZER PFO Occluder
Intervention Description
patent foramen ovale closure device
Intervention Type
Other
Intervention Name(s)
Standard of Care - Medical Management
Intervention Description
Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole
Primary Outcome Measure Information:
Title
Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization
Description
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 Outcome Measure Information:
Title
Rate of Complete PFO Closure (Assessed by TEE Bubble Study) at the 6-month Follow-up in the Device Group
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Saver, MD
Organizational Affiliation
UCLA Stroke Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John D Carroll, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Smalling, MD
Organizational Affiliation
University of Texas Houston Health Science Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Thaler, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
LAC + USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Summit Medical Center
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Kaiser Permanente
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
South Denver Cardiology Associates
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Medical Center of the Rockies
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
George Washington University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
St. Vincent's Medical Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3078
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Neurologic Associates Inc
City
Palos Heights
State/Province
Illinois
ZIP/Postal Code
60463
Country
United States
Facility Name
OSF St. Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Southern Illinois University Neurology
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Indiana Heart Physicians
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Ruan Neurology
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Midatlantic Cardiovascular Associates
City
Towson
State/Province
Maryland
ZIP/Postal Code
21014
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0316
Country
United States
Facility Name
St. Mary's Duluth Clinic
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Methodist Hospital/Park Nicollet Medical Center
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-2045
Country
United States
Facility Name
Our Lady of Lourdes Medical Center
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08034
Country
United States
Facility Name
University of Medicine and Dentistry of New Jersy
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
DENT Neurologic Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Moses H. Cone Memorial Hospital
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27410
Country
United States
Facility Name
Neurology and Neuroscience Associates
City
Akron
State/Province
Ohio
ZIP/Postal Code
44320
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Providence St. Vincent's Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Oregon Stroke Center, OHSU
City
Portland
State/Province
Oregon
ZIP/Postal Code
97329
Country
United States
Facility Name
LeHigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18105
Country
United States
Facility Name
Penn State Milton South Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17543
Country
United States
Facility Name
St. Mary's Medical Center
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19067
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
North Central Heart Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
St. Thomas Neurology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-8802
Country
United States
Facility Name
UT Southwestern Medical School
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8897
Country
United States
Facility Name
University of Texas Houston Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Sentara Virginia Beach General Hospital
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
UW Medicine Stroke Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Charleston Area Medical Center
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
University of Wisconsin Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Marshfield Clinic
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Royal Columbian Hospital
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W5
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1Y6
Country
Canada
Facility Name
Stroke Prevention & Atherosclerosis Research Center (SPARC) - Robarts Research Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 2V2
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
28902590
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.
Results Reference
background
PubMed Identifier
23514286
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.
Results Reference
background
Links:
URL
http://www.respectstudy.com
Description
Related Info

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

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