Prospective Clinical Follow-up After the Percutaneous Closure of a Patent Foramen Ovale

NCT ID: NCT01149447

Last Updated: 2012-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2001-01-31

Brief Summary

Following a cryptogenic stroke, many patients are nowadays treated with the percutaneous closure of a patent foramen ovale (PFO), assuming that the aetiology of the stroke is secondary to a paradoxical embolism. After the PFO closure procedure a dual antiplatelet regimen is often prescribed for 3-6 months and several cardiologic and neurologic follow-up exams are scheduled in the first 12 months of follow-up. Usually a transthoracic +/- transoesophageal echocardiography (TTE +/- TEE) are performed at 6 months, however this kind of control is not systematically performed. In order to improve the clinical outcomes in this young patients' population, the investigators prospectively perform a complete cardiologic and neurologic follow-up program to all patients undergoing a successful percutaneous closure of a PFO.

The aim of these controls is to confirm the good position of the PFO-device, to confirm the absence of any residual right to left shunt or any significant atrial arrhythmias Furthermore this prospective follow-up will analyze the possible mechanisms leading to a cerebral stroke recurrence (e.g. size of the PFO, presence of an atrial septal aneurysm, presence of a residual shunt, size of the utilized closure device, ....).

Detailed Description

At follow-up the following exams will be performed:

• at hospital discharge: chest X-ray +/- TTE + 7-days event loop record (ELR)
• at 6 months: clinical cardiologic and neurologic examination + TTE + TEE + 7-days ELR + trans-cranial doppler (TCD) with micro bubbles detection.
• at 1 year: clinical cardiologic and neurologic examination + TTE +/- TEE + 7-days ELR + trans-cranial doppler (TCD) with micro bubbles detection +/- cerebral MRI

Conditions

Stroke; Foramen Ovale, Patent

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 18 years old patients
• signed informed consent
• all consecutive patients undergoing a successful percutaneous closure of a PFO secondary to a cryptogenic stroke

Exclusion Criteria

• all patients with an alternative aetiology of the initial stroke
• all patients in whom the percutaneous closure of the PFO is contraindicated
• all patients with a known allergy to aspirin and or clopidogrel

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Robert F Bonvini

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert F Bonvini, MD

Role: PRINCIPAL_INVESTIGATOR

University of Geneva

Locations

University of Geneva

Geneva, Canton of Geneva, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Robert F Bonvini, MD

Role: CONTACT

robert.bonvini@hcuge.ch

004122372727200

Facility Contacts

Robert F Bonvini, MD

Role: primary

robert.bonvini@hcuge.ch

0041223727200

Related Links

http://www.hug-ge.ch

university of geneva web site

Other Identifiers

PFO-HUG-Study

Identifier Type: -

Identifier Source: org_study_id