Patent Foramen OvaleNCT00196027
Paradigm I Clinical Trial: Study of the PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemia Attack or Paradoxical Embolism
A study testing PFX Closure System in people with Patent Foramen Ovale, run by Cierra at 1 site in Germany.
Trial summary
The primary objective of this study is to demonstrate the safety of the PFX Closure System when utilized for patients with patent foramen ovale (PFO) suffering from cryptogenic stroke, transient ischemic attacks or paradoxical embolism. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Patent Foramen Ovale
- What is being tested?
- PFX Closure System
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2005to not given
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is between 18 and 65 years old.
- Documented patent foramen ovale as determined by positive micro bubble study demonstrating right to left shunt and/or anatomic detection and functional assessment by pre-operative TCD and peri-operative echocardiography or ultrasound.
- Subjects with a history of cryptogenic stroke, transient ischemic attack or paradoxical embolism due to presumed paradoxical embolism through a PFO.
- Negative pregnancy test in women who are of child-bearing potential.
- Signed Informed Consent form.
Who cannot join
- Presence of thrombus at the intended site of closure, in left atrial appendage, or documented evidence of venous thrombus in the vessels through which access to the PFO is gained.
- Active endocarditis, or other infections producing a bacteremia.
- Presence of atrial septal defects or fenestrations which allow right-to-left shunting.
- Presence of implanted cardiac valves, pacemaker, implantable cardioverters/defibrillators (ICDs) or vena cava filters.
- Subjects with an intra-cardiac mass, tumor, clot or vegetation.
- Large, redundant atrial septal aneurysm that would prohibit adequate device access to the PFO or closure of the PFO, in the judgment of the investigator. A coexisting redundant atrial septal aneurysm is considered large if it prohibits the ability of the operator to adequately achieve vacuum suction necessary to achieve PFO closure.
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- Presence of arrhythmia requiring pharmacologic or electrical therapy intervention or 1st degree block.
- Current enrollment in any investigational trial(s) using devices implanted in the vascular system or enrolled in any experimental drug study(ies) within three months of study entry.
- History of stroke or TIA within the past 14 days.
- Source of stroke other than paradoxical embolization.
- Hemodynamic instability or shock.
- Hypercoagulable disorder.
- Subjects with coagulation disorders who are unable to take antiplatelet or anticoagulant therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of the PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemia Attack or Paradoxical Embolism
The primary objective of this study is to demonstrate the safety of the PFX Closure System when utilized for patients with patent foramen ovale (PFO) suffering from cryptogenic stroke, transient ischemic attacks or paradoxical embolism.
Read the detailed description
Patent Foramen Ovale has been implicated in the etiology of paradoxical embolism, cryptogenic stroke, transient ischemic attack (TIA), 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; we propose to use a non-implantable system to safely effect closure.
- Conditions
- Patent Foramen Ovale
- Being tested
- PFX Closure System
- Medical subject headings
- Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFX Closure SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
PFO closure as measured by transesophageal echocardiography (TEE) or transcranial Doppler (TCD) acutely post procedure
Secondary outcomes (4)
PFO closure as measured by TEE or TCD at 30 days post procedure
Neurological death and adverse event (AE) rates for all subjects through 30 day follow-up
New arrhythmia rate through 30 day follow-up. For any subjects with new arrhythmia, arrhythmia status will also be evaluated at a follow-up visit from 3 to 6 months post procedure
PFO closure rate at 3 to 6 months for any subject not demonstrating complete closure at the 30 day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startApr 2005
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
- 40 participants
Sponsor and investigators
- Lead sponsor
- Cierra
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Horst Sievert, MD, Principal investigator, Cardio Vasculares Centrum - Sankt Katharien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196027
- Sponsor's protocol ID
- 2005-001 version 1
- Status last verified
- Nov 2006
- First submitted
- 12 Sep 2005
- Last updated
- 29 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemia Attack or Paradoxical Embolism
- ClinicalTrials.gov ID
- NCT00196027
- Acronym / sponsor ID
- 2005-001 version 1
- Conditions
- Patent Foramen Ovale
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- CierraIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- First posted
- 20 Sep 2005 (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 of the PFX Closure System when utilized for patients with patent foramen ovale (PFO) suffering from cryptogenic stroke, transient ischemic attacks or paradoxical embolism.
Detailed description
Patent Foramen Ovale has been implicated in the etiology of paradoxical embolism, cryptogenic stroke, transient ischemic attack (TIA), 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; we propose to use a non-implantable system to safely effect closure.
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
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is between 18 and 65 years old.
- Documented patent foramen ovale as determined by positive micro bubble study demonstrating right to left shunt and/or anatomic detection and functional assessment by pre-operative TCD and peri-operative echocardiography or ultrasound.
- Subjects with a history of cryptogenic stroke, transient ischemic attack or paradoxical embolism due to presumed paradoxical embolism through a PFO.
- Negative pregnancy test in women who are of child-bearing potential.
- Signed Informed Consent form.
Key exclusion criteria (13 listed)
- Presence of thrombus at the intended site of closure, in left atrial appendage, or documented evidence of venous thrombus in the vessels through which access to the PFO is gained.
- Active endocarditis, or other infections producing a bacteremia.
- Presence of atrial septal defects or fenestrations which allow right-to-left shunting.
- Presence of implanted cardiac valves, pacemaker, implantable cardioverters/defibrillators (ICDs) or vena cava filters.
- Subjects with an intra-cardiac mass, tumor, clot or vegetation.
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 Closure System | Device | – |
Primary outcome
PFO closure as measured by transesophageal echocardiography (TEE) or transcranial Doppler (TCD) acutely post procedure
4 secondary outcomes
PFO closure as measured by TEE or TCD at 30 days post procedure
Neurological death and adverse event (AE) rates for all subjects through 30 day follow-up
New arrhythmia rate through 30 day follow-up. For any subjects with new arrhythmia, arrhythmia status will also be evaluated at a follow-up visit from 3 to 6 months post procedure
PFO closure rate at 3 to 6 months for any subject not demonstrating complete closure at the 30 day follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2006.
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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.
Horst Sievert, MD principal investigator
Cardio Vasculares Centrum - Sankt Katharien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PFX Closure System in people with Patent Foramen Ovale, run by Cierra at 1 site in Germany.
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 5 inclusion and 13 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 29 Nov 2006. 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 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 as measured by transesophageal echocardiography (TEE) or transcranial Doppler (TCD) acutely post procedure. 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 29 Nov 2006.