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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01149447

Acronym

PFO-HUG

Enrollment

200

Registered

2010-06-23

Start date

2001-01-31

Completion date

Unknown

Last updated

2012-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foramen Ovale, Patent, Stroke

Keywords

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

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
residual shunt at 6-12 months follow-up	6-12 months	incidence and clinical relevance of right to left residual shunts at 6-12 months after the successful closure of the PFO
stroke recurrence	6-12 months	incidence and clinical predictors of stroke recurrence at 6-12 months
possible other aetiologies of the initial cryptogenic stroke	6-12 months	during the 12 months follow-up all other possible aetiologies explaining the initial cryptogenic stroke will be taken into consideration

Secondary

Measure	Time frame	Description
6 months dual antiplatelet regimen safety and efficacy	6 months	confirm the safety and efficacy of the adopted 6 months dual antiplatelet regimen

Countries

Switzerland

Contacts

Primary ContactRobert F Bonvini, MD

robert.bonvini@hcuge.ch004122372727200

Outcome results