Overview

This trial is active, not recruiting.

Conditions embolism, paradoxical, heart septal defects, atrial
Treatments percutaneous closure of patent foramen ovale, medical antitrhombotic treatment
Phase phase 4
Sponsor Foundation for Cardiovascular Research, Zurich
Collaborator AGA Medical Corporation
Start date February 2000
End date February 2011
Trial size 414 participants
Trial identifier NCT00166257, ICN98008

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
medical antitrhombotic treatment
Investigator's choice: Anticoagulation to INR 2.0 - 3.0 OR Aspirin 100-325 mg/d OR Clopidogrel 75-150 mg/d
(Experimental)
Percutaneous closure of patent foramen ovale
percutaneous closure of patent foramen ovale
Percutaneous implantation of an AMPLATZER® PFO Occluder

Primary Outcomes

Measure
Time to death (Fatal stroke, cardiovascular, non-CV),
time frame: continuosly
non-fatal cerebrovascular event,
time frame: continuosly
peripheral embolism
time frame: continuosly

Secondary Outcomes

Measure
New arrhythmias,
time frame: continuosly
myocardial infarction
time frame: continuosly
rehospitalization related to PFO or its treatment
time frame: continuosly
device problems
time frame: continuosly
bleeding complications
time frame: continuosly

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Randomized Clinical Trial Comparing the Efficacy of Percutaneous Closure of Patent Foramen Ovale (PFO) With Medical Treatment in Patients With Cryptogenic Embolism
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: 1. 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. 2. 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2009.
Information provided to ClinicalTrials.gov by Foundation for Cardiovascular Research, Zurich.