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Prospective Clinical Follow-up After the Percutaneous Closure of a Patent Foramen Ovale (PFO-HUG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01149447
Recruitment Status : Unknown
Verified August 2011 by Robert F Bonvini, University Hospital, Geneva.
Recruitment status was:  Recruiting
First Posted : June 23, 2010
Last Update Posted : August 16, 2012
Sponsor:
Information provided by (Responsible Party):
Robert F Bonvini, 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, ....).


Condition or disease
Stroke Foramen Ovale, Patent

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

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Clinical Follow-up of Patients Presenting With Cryptogenic Stroke Treated With the Percutaneous Closure of a Patent Foramen Ovale
Study Start Date : January 2001



Primary Outcome Measures :
  1. residual shunt at 6-12 months follow-up [ Time Frame: 6-12 months ]
    incidence and clinical relevance of right to left residual shunts at 6-12 months after the successful closure of the PFO

  2. stroke recurrence [ Time Frame: 6-12 months ]
    incidence and clinical predictors of stroke recurrence at 6-12 months

  3. possible other aetiologies of the initial cryptogenic stroke [ Time Frame: 6-12 months ]
    during the 12 months follow-up all other possible aetiologies explaining the initial cryptogenic stroke will be taken into consideration


Secondary Outcome Measures :
  1. 6 months dual antiplatelet regimen safety and efficacy [ Time Frame: 6 months ]
    confirm the safety and efficacy of the adopted 6 months dual antiplatelet regimen



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01149447


Contacts
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Contact: Robert F Bonvini, MD 004122372727200 robert.bonvini@hcuge.ch

Locations
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Switzerland
University of Geneva Recruiting
Geneva, GE, Switzerland, 1211
Contact: Robert F Bonvini, MD    0041223727200    robert.bonvini@hcuge.ch   
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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Principal Investigator: Robert F Bonvini, MD University of Geneva
Additional Information:
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Responsible Party: Robert F Bonvini, MD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01149447    
Other Study ID Numbers: PFO-HUG-Study
First Posted: June 23, 2010    Key Record Dates
Last Update Posted: August 16, 2012
Last Verified: August 2011
Keywords provided by Robert F Bonvini, University Hospital, Geneva:
cryptogenic stroke
percutaneous closure of PFO
follow-up exams
Additional relevant MeSH terms:
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Stroke
Foramen Ovale, Patent
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities