Patent Foramen OvaleNCT00335296
PFx Closure System in Subjects With Cryptogenic Stroke,Transient Ischemic Attack,Migraine or Decompression Illness(PFO)
A study testing PFx catheter in people with Patent Foramen Ovale, run by Cierra at 4 sites in 3 countries.
Trial summary
The primary objective of this study is to demonstrate the safety and performance of the PFx Closure System when utilized for patients with PFOs suffering from cryptogenic stroke, transient ischemic attack, migraine or decompression illness. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patent Foramen Ovale
- What is being tested?
- PFx catheter
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 4 sitesin 3 countries
- Study dates
- May 2006to Dec 2007
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years old
- Documented PFO
- Subjects with one or more of the following:cryptogenic stroke, transient ischemic attack, embolism, migraine headaches, decompression illness
Who cannot join
- Inappropriate anatomy (vascular or cardiac) or inappropriate medical condition for PFO closure and study medications.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
France2 sites
Institut Hospitalier Jacques Carter
Massy
Bichat Hospital
Paris, 75877
Germany1 site
Cardiovascular Center Frankfurt Sankt katharinen
Frankfurt, 60389
About this study
Official title: The Paradigm IIca/III Trial: PFx Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness
The primary objective of this study is to demonstrate the safety and performance of the PFx Closure System when utilized for patients with PFOs suffering from cryptogenic stroke, transient ischemic attack, migraine or decompression illness.
Read the detailed description
Patent Foramen Ovale has been implicated in the etiology of paradoxical embolism, cryptogenic stroke, transient ischemic attack, and right to left gas embolism in severe decompression illness. An association between patent foramen ovale and severe migraine headaches has also been reported. Several implantable devices are being used for percutaneous closure of patent foramen ovale; this study uses a non-implantable system to safely effect closure with the application of radiofrequency energy.
- Conditions
- Patent Foramen Ovale
- Being tested
- PFx catheter
- Keywords
- PFO, Migraine, Stroke, TIA (transient ischemic attack), Decompression Illness
- Medical subject headings
- Foramen Ovale, Patent, Migraine Disorders, Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFx catheterDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
PFO closure 6 months post procedure
Measured: 6 months
Secondary outcomes (3)
PFO closure at 30 days and 12 months post procedure
Measured: 30 days, 12 months
AE event rates for all subjects
Measured: 30 days, 6 and 12 months
Migraine severity
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2006 (estimated)
- Study startMay 2006
- Study completionDec 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Foramen OvaleStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cierra
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alec Vahanian, MD, Principal investigator, Bichat Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335296
- Sponsor's protocol ID
- CA0005/09
- Status last verified
- Dec 2007
- First submitted
- 8 Jun 2006
- Last updated
- 24 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Paradigm IIca/III Trial: PFx Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness
- ClinicalTrials.gov ID
- NCT00335296
- Acronym / sponsor ID
- CA0005/09
- Conditions
- Patent Foramen Ovale
- Keywords
- PFO, Migraine, Stroke, TIA (transient ischemic attack), Decompression Illness
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CierraIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Study completion
- Dec 2007 (estimated)
- First posted
- 9 Jun 2006 (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.
The primary objective of this study is to demonstrate the safety and performance of the PFx Closure System when utilized for patients with PFOs suffering from cryptogenic stroke, transient ischemic attack, migraine or decompression illness.
Detailed description
Patent Foramen Ovale has been implicated in the etiology of paradoxical embolism, cryptogenic stroke, transient ischemic attack, and right to left gas embolism in severe decompression illness. An association between patent foramen ovale and severe migraine headaches has also been reported. Several implantable devices are being used for percutaneous closure of patent foramen ovale; this study uses a non-implantable system to safely effect closure with the application of radiofrequency energy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 65 years old
- Documented PFO
- Subjects with one or more of the following:cryptogenic stroke, transient ischemic attack, embolism, migraine headaches, decompression illness
Key exclusion criteria (1 listed)
- Inappropriate anatomy (vascular or cardiac) or inappropriate medical condition for PFO closure and study medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PFx catheter | Device | – |
Primary outcome
PFO closure 6 months post procedure
Time frame: 6 months
3 secondary outcomes
PFO closure at 30 days and 12 months post procedure
Time frame: 30 days, 12 months
AE event rates for all subjects
Time frame: 30 days, 6 and 12 months
Migraine severity
Time frame: 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2007.
- Related InfoLink provided by the sponsor.
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Active Surveillance and Safety/Efficacy Evaluation of Innovative Devices for Structural Heart Disease Intervention
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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.
Alec Vahanian, MD principal investigator
Bichat Hospital
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PFx catheter in people with Patent Foramen Ovale, run by Cierra at 4 sites in 3 countries.
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 1 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: paused, as of the sponsor's last update on 24 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Belgium, Germany. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFO closure 6 months post procedure (time frame: 6 months). 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 24 Dec 2007; AzTrials last refreshed its copy on 3 Nov 2026.