Prospective Clinical Follow-up After the Percutaneous Clo... | NCT01149447

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

NCT01149447

Sponsor

University Hospital, Geneva

Status

Unknown status

Last Update Posted

Aug 16, 2012Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Stroke
Foramen Ovale, Patent

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2001

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 22, 2010

First Submission Date that Met QC Criteria

Jun 22, 2010

First Posted Date

Jun 23, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2012

Last Update Posted Date

Aug 16, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

all consecutive patients presenting with a cryptogenic stroke, in whom a successful percutaneous closure of their PFO is performed

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Robert F Bonvini, MD	Contact	004122372727200		robert.bonvini@hcuge.ch

Overall Officials

Name	Affiliation	Role
Robert F Bonvini, MD	University of Geneva, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Geneva	Recruiting	Geneva	Canton of Geneva	1211	Switzerland

Label	URL
university of geneva web site	View source

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D054092	Foramen Ovale, Patent
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

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Browse Branches

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