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PC-Trial: Patent Foramen Ovale and Cryptogenic Embolism

Primary Purpose

Embolism, Paradoxical, Heart Septal Defects, Atrial

Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Percutaneous closure of patent foramen ovale
Medical antitrhombotic treatment
Sponsored by
Foundation for Cardiovascular Research, Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Embolism, Paradoxical focused on measuring Paradoxical embolism, Patent foramen ovale,

Eligibility Criteria

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

Inclusion Criteria: Age below 60 years Ischemic stroke or peripheral thromboembolism, radiologically verified Absence of an identifiable cause of embolism Echocardiographically verified patent foramen ovale Sufficient recovery from index event to allow independent daily activities Exclusion Criteria: Any identifiable cause for thromboembolic event other than PFO Cardiac diseases: mural thrombus, dilated cardiomyopathy, prosthetic heart valve or mitral stenosis, endocarditis, atrial fibrillation Vascular system: significant atherosclerosis or dissection of the aorta, collagen vascular disease, arteritis, vasculitis Pre-existing neurologic disorders or intracranial disease, e.g., multiple sclerosis, arteriovenous malformations, previous hemorrhage Contraindications for antithrombotic or anticoagulant therapy Patients already on chronic anticoagulant therapy for another disease Previous surgical or percutaneous PFO-closure Drug or alcohol abuse Pregnancy Septicemia or severe infectious disease Severe CNS disease No informed consent Foreseen difficulties with study compliance, especially the long-term follow-up

Sites / Locations

  • Monash Medical Centre
  • Sir Charles Gairdner Hospital
  • Alfred Hospital
  • Universitätsklinik für Innere Medizin II
  • A.Z. Sint-Jan AV
  • University Hospital / Inselspital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Medical antitrhombotic treatment

Device Implant

Arm Description

Percutaneous closure of patent foramen ovale

Outcomes

Primary Outcome Measures

Time to death (Fatal stroke, cardiovascular, non-CV),
non-fatal cerebrovascular event,
peripheral embolism

Secondary Outcome Measures

New arrhythmias,
myocardial infarction
rehospitalization related to PFO or its treatment
device problems
bleeding complications

Full Information

First Posted
September 9, 2005
Last Updated
May 26, 2009
Sponsor
Foundation for Cardiovascular Research, Zurich
Collaborators
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00166257
Brief Title
PC-Trial: Patent Foramen Ovale and Cryptogenic Embolism
Official Title
Randomized Clinical Trial Comparing the Efficacy of Percutaneous Closure of Patent Foramen Ovale (PFO) With Medical Treatment in Patients With Cryptogenic Embolism
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2000 (undefined)
Primary Completion Date
February 2011 (Anticipated)
Study Completion Date
May 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Foundation for Cardiovascular Research, Zurich
Collaborators
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare two treatments strategies to prevent further attacks in patients who have suffered an stroke or occlusion of a major artery with no obvious reason other than a persistent small opening between the upper heart chambers
Detailed Description
In patients who have suffered a stroke or occlusion of a large artery in another body part of unknown origin a possible cause is a small opening between the upper heart chambers (patent foramen ovale, it is called). After birth this opening closes in 75% of the population, while it persists in 25% of people. It may allow a small blood clot to pass from the veins of the legs through the heart into the brain or other parts of the body. In order to reduce the risk for a further attack we have today more therapeutic options to choose from but it is unclear which strategy have the best outcome. This study is created to compare the effect of two treatment strategies: Medical treatment The purpose of medical treatment is to dilute the blood to a degree, that no thrombus formation occurs. Since the opening in the heart persists, treatment is usually recommended lifelong. And patients treated with coumadin must undergo regular blood tests to ensure an adequate effect of the drug. Catheter closure of patent foramen ovale An alternative method developed to close the small opening in the heart utilizes catheters which are introduced in a blood vessel in the groin and from there advanced to the heart. An umbrella device is then delivered through the catheter, positioned within the small defect and released. The umbrella is overgrown with own tissue within weeks to months and closes the small defect for ever.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Embolism, Paradoxical, Heart Septal Defects, Atrial
Keywords
Paradoxical embolism, Patent foramen ovale,

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
414 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medical antitrhombotic treatment
Arm Type
Active Comparator
Arm Title
Device Implant
Arm Type
Experimental
Arm Description
Percutaneous closure of patent foramen ovale
Intervention Type
Device
Intervention Name(s)
Percutaneous closure of patent foramen ovale
Intervention Description
Percutaneous implantation of an AMPLATZER® PFO Occluder
Intervention Type
Drug
Intervention Name(s)
Medical antitrhombotic treatment
Intervention Description
Investigator's choice: Anticoagulation to INR 2.0 - 3.0 OR Aspirin 100-325 mg/d OR Clopidogrel 75-150 mg/d
Primary Outcome Measure Information:
Title
Time to death (Fatal stroke, cardiovascular, non-CV),
Time Frame
continuosly
Title
non-fatal cerebrovascular event,
Time Frame
continuosly
Title
peripheral embolism
Time Frame
continuosly
Secondary Outcome Measure Information:
Title
New arrhythmias,
Time Frame
continuosly
Title
myocardial infarction
Time Frame
continuosly
Title
rehospitalization related to PFO or its treatment
Time Frame
continuosly
Title
device problems
Time Frame
continuosly
Title
bleeding complications
Time Frame
continuosly

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: Age below 60 years Ischemic stroke or peripheral thromboembolism, radiologically verified Absence of an identifiable cause of embolism Echocardiographically verified patent foramen ovale Sufficient recovery from index event to allow independent daily activities Exclusion Criteria: Any identifiable cause for thromboembolic event other than PFO Cardiac diseases: mural thrombus, dilated cardiomyopathy, prosthetic heart valve or mitral stenosis, endocarditis, atrial fibrillation Vascular system: significant atherosclerosis or dissection of the aorta, collagen vascular disease, arteritis, vasculitis Pre-existing neurologic disorders or intracranial disease, e.g., multiple sclerosis, arteriovenous malformations, previous hemorrhage Contraindications for antithrombotic or anticoagulant therapy Patients already on chronic anticoagulant therapy for another disease Previous surgical or percutaneous PFO-closure Drug or alcohol abuse Pregnancy Septicemia or severe infectious disease Severe CNS disease No informed consent Foreseen difficulties with study compliance, especially the long-term follow-up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernhard Meier, MD
Organizational Affiliation
Dept. Cardiology, University Hospital Insel, Berne, Switzerland
Official's Role
Study Chair
Facility Information:
Facility Name
Monash Medical Centre
City
Melbourne
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
Country
Australia
Facility Name
Alfred Hospital
City
Prahan
Country
Australia
Facility Name
Universitätsklinik für Innere Medizin II
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
A.Z. Sint-Jan AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
University Hospital / Inselspital
City
Bern
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
23514285
Citation
Meier B, Kalesan B, Mattle HP, Khattab AA, Hildick-Smith D, Dudek D, Andersen G, Ibrahim R, Schuler G, Walton AS, Wahl A, Windecker S, Juni P; PC Trial Investigators. Percutaneous closure of patent foramen ovale in cryptogenic embolism. N Engl J Med. 2013 Mar 21;368(12):1083-91. doi: 10.1056/NEJMoa1211716.
Results Reference
derived
PubMed Identifier
21356042
Citation
Khattab AA, Windecker S, Juni P, Hildick-Smith D, Dudek D, Andersen HR, Ibrahim R, Schuler G, Walton AS, Wahl A, Mattle HP, Meier B. Randomized clinical trial comparing percutaneous closure of patent foramen ovale (PFO) using the Amplatzer PFO Occluder with medical treatment in patients with cryptogenic embolism (PC-Trial): rationale and design. Trials. 2011 Feb 28;12:56. doi: 10.1186/1745-6215-12-56.
Results Reference
derived

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PC-Trial: Patent Foramen Ovale and Cryptogenic Embolism

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