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

• Conditions: Stroke; Foramen Ovale, Patent

• Registration Number: NCT01149447
• Lead Sponsor: University Hospital, Geneva

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

Study Timeline

• Study Start: 2001-01
• Study First Submitted: 2010-06-22
• Study First Submitted QC: 2010-06-22
• Study First Posted: 2010-06-23
• Status Verified: 2011-08
• Last Update Submitted: 2012-08-15
• Last Update Posted: 2012-08-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
residual shunt at 6-12 months follow-up	6-12 months	incidence and clinical relevance of right to left residual shunts at 6-12 months after the successful closure of the PFO
possible other aetiologies of the initial cryptogenic stroke	6-12 months	during the 12 months follow-up all other possible aetiologies explaining the initial cryptogenic stroke will be taken into consideration
stroke recurrence	6-12 months	incidence and clinical predictors of stroke recurrence at 6-12 months

Secondary Outcome Measures

Name	Time	Method
6 months dual antiplatelet regimen safety and efficacy	6 months	confirm the safety and efficacy of the adopted 6 months dual antiplatelet regimen

Trial Locations

Locations (1)

University of Geneva; 🇨🇭 Geneva, GE, Switzerland