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

NCT ID: NCT01149447

Last Updated: 2012-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-01-31

Brief Summary

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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

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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

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Stroke Foramen Ovale, Patent

Keywords

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cryptogenic stroke percutaneous closure of PFO follow-up exams

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Robert F Bonvini

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert F Bonvini, MD

Role: PRINCIPAL_INVESTIGATOR

University of Geneva

Locations

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University of Geneva

Geneva, Canton of Geneva, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Robert F Bonvini, MD

Role: CONTACT

Phone: 004122372727200

Email: [email protected]

Facility Contacts

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Robert F Bonvini, MD

Role: primary

Related Links

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http://www.hug-ge.ch

university of geneva web site

Other Identifiers

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PFO-HUG-Study

Identifier Type: -

Identifier Source: org_study_id