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

NCT01149447 | Unknown DMC

• 1 other identifier: PFO-HUG-Study
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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, ....).

Conditions

Stroke; Foramen Ovale, Patent

Keywords

cryptogenic stroke; percutaneous closure of PFO; follow-up exams

Outcome Measures

Primary Outcomes (3)

• 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

• stroke recurrence

  incidence and clinical predictors of stroke recurrence at 6-12 months

  6-12 months

• 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

Secondary Outcomes (1)

• 6 months dual antiplatelet regimen safety and efficacy

  6 months

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• years old patients
• signed informed consent
• all consecutive patients undergoing a successful percutaneous closure of a PFO secondary to a cryptogenic stroke

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

University of Geneva

Geneva, Canton of Geneva, 1211, Switzerland

RECRUITING

Related Links

• university of geneva web site

MeSH Terms

Conditions

Stroke; Foramen Ovale, Patent; Ischemic Stroke

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Robert F Bonvini, MD

  University of Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert F Bonvini, MD

CONTACT

004122372727200; robert.bonvini@hcuge.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 22, 2010
• First Posted: June 23, 2010
• Study Start: January 1, 2001
• Last Updated: August 16, 2012

Record last verified: 2011-08

Locations

CH (1)