StrokePFO-HUGNCT01149447
Prospective Clinical Follow-up After the Percutaneous Closure of a Patent Foramen Ovale
An observational study of Stroke and Foramen Ovale, Patent, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Foramen Ovale, Patent
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2001to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all consecutive patients presenting with a cryptogenic stroke, in whom a successful percutaneous closure of their PFO is performed
Who may be able to join
- 18 years old patients
- signed informed consent
- all consecutive patients undergoing a successful percutaneous closure of a PFO secondary to a cryptogenic stroke
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University of Geneva
Geneva, Canton of Geneva, 1211
Robert F Bonvini, MD, 0041223727200, robert.bonvini@hcuge.ch
About this study
Official title: Prospective Clinical Follow-up of Patients Presenting With Cryptogenic Stroke Treated With the Percutaneous Closure of a Patent Foramen Ovale
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, ....).
Read the 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
- Conditions
- Stroke, Foramen Ovale, Patent
- Keywords
- cryptogenic stroke, percutaneous closure of PFO, follow-up exams
- Medical subject headings
- Stroke, Foramen Ovale, Patent, Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6-12 months
stroke recurrence
incidence and clinical predictors of stroke recurrence at 6-12 months
Measured: 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
Measured: 6-12 months
Secondary outcomes (1)
6 months dual antiplatelet regimen safety and efficacy
confirm the safety and efficacy of the adopted 6 months dual antiplatelet regimen
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2010 (estimated)
- Study startJan 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert F Bonvini, University Hospital, Geneva
- Investigators
- Robert F Bonvini, MD, Principal investigator, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01149447
- Sponsor's protocol ID
- PFO-HUG-Study
- Acronym
- PFO-HUG
- Status last verified
- Aug 2011
- First submitted
- 22 Jun 2010
- Last updated
- 16 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Follow-up of Patients Presenting With Cryptogenic Stroke Treated With the Percutaneous Closure of a Patent Foramen Ovale
- ClinicalTrials.gov ID
- NCT01149447
- Acronym / sponsor ID
- PFO-HUG / PFO-HUG-Study
- Conditions
- Stroke, Foramen Ovale, Patent
- Keywords
- cryptogenic stroke, percutaneous closure of PFO, follow-up exams
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Jan 2001
- First posted
- 23 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all consecutive patients presenting with a cryptogenic stroke, in whom a successful percutaneous closure of their PFO is performed
Key inclusion criteria (3 listed)
- 18 years old patients
- signed informed consent
- all consecutive patients undergoing a successful percutaneous closure of a PFO secondary to a cryptogenic stroke
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
stroke recurrence
Time frame: 6-12 months
incidence and clinical predictors of stroke recurrence at 6-12 months
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
1 secondary outcome
6 months dual antiplatelet regimen safety and efficacy
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2012.
- university of geneva web siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert F Bonvini, MD principal investigator
University of Geneva, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Foramen Ovale, Patent, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert F Bonvini, MD (004122372727200, robert.bonvini@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
residual shunt at 6-12 months follow-up (time frame: 6-12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2012; AzTrials last refreshed its copy on 8 Nov 2026.