Clinical trial NCT01149447: Prospective Clinical Follow-up After the Percutaneous Closure of a Patent Foramen Ovale
Official title: Prospective Clinical Follow-up of Patients Presenting With Cryptogenic Stroke Treated With the Percutaneous Closure of a Patent Foramen Ovale
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Foramen Ovale, Patent
Keywords: cryptogenic stroke
percutaneous closure of PFO
follow-up exams
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2010-06-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all consecutive patients presenting with a cryptogenic stroke, in whom a successful percutaneous closure of their PFO is performed

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

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

Primary outcomes:
measure: residual shunt at 6-12 months follow-up
timeFrame: 6-12 months
measure: stroke recurrence
timeFrame: 6-12 months
measure: possible other aetiologies of the initial cryptogenic stroke
timeFrame: 6-12 months
Secondary outcomes:
measure: 6 months dual antiplatelet regimen safety and efficacy
timeFrame: 6 months
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University of Geneva
state: GE
Study officials:
affiliation: University of Geneva
name: Robert F Bonvini, MD
role: PRINCIPAL_INVESTIGATOR
References: