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

Stroke Clinical Trial

— PFO-HUG  

Official title:

Prospective Clinical Follow-up of Patients Presenting With Cryptogenic Stroke Treated With the Percutaneous Closure of a Patent Foramen Ovale

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01149447
• Other study ID #: PFO-HUG-Study
• Status: Recruiting
• Phase: N/A
• First received: June 22, 2010
• Last updated: August 15, 2012
• Start date: January 2001

Study information

• Verified date: August 2011
• Source: University Hospital, Geneva
• Contact: Robert F Bonvini, MD
• Phone: 004122372727200
• Email: robert.bonvini[@]hcuge.ch
• Is FDA regulated: No
• Health authority: Commision d'éthique central:Hopitaux Universitaires de Genève:Rue Gabrielle-Perret-Gentil 4:1211 Genève 14:
• Study type: Observational

Clinical Trial 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, ....).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Stroke

Locations

Country	Name	City	State
Switzerland	University of Geneva	Geneva	GE

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	residual shunt at 6-12 months follow-up	incidence and clinical relevance of right to left residual shunts at 6-12 months after the successful closure of the PFO	6-12 months	No
Primary	stroke recurrence	incidence and clinical predictors of stroke recurrence at 6-12 months	6-12 months	Yes
Primary	possible other aetiologies of the initial cryptogenic stroke	during the 12 months follow-up all other possible aetiologies explaining the initial cryptogenic stroke will be taken into consideration	6-12 months	No
Secondary	6 months dual antiplatelet regimen safety and efficacy	confirm the safety and efficacy of the adopted 6 months dual antiplatelet regimen	6 months	Yes

External Links

•   university of geneva web site