Foramen Ovale, PatentNCT00196040
The Paradigm II Trial: PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness
A study testing PFX Closure System in people with Foramen Ovale, Patent, run by Cierra at 1 site in Germany.
Trial summary
The primary objective of this study is to demonstrate the safety and efficacy of the PFX Closure System when utilized for patent foramen ovale (PFO) in patients suffering from cryptogenic stroke (undetermined cause of stroke), transient ischemic attack (brief neurological dysfunction), migraine or decompression… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Foramen Ovale, Patent
- What is being tested?
- PFX Closure System
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2005to Nov 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
- 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 transcranial Doppler (TCD) and peri-operative echocardiography or ultrasound.
- Subjects with one or more of the following:
- history of cryptogenic stroke, transient ischemic attack (TIA) or embolism due to presumed paradoxical embolism through a PFO; or
- history of severe migraine headaches, despite attempted treatment with available migraine medications, for whom other specific causes of migraine headache, such as underlying disease or medications, have been ruled out; or
- history of severe decompression illness.
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- Negative pregnancy test in women who are of child-bearing potential
- Signed Informed Consent form
- Additional Inclusion Criteria for Migraine Subjects:
- Onset of migraine before age of 50 years
- History of migraine > 1 year
- Migraine frequency greater than 1 migraine per month
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 defect(s) or fenestrations which allow shunting
- Presence of implanted cardiac valves, pacemakers, cardioverters/defibrillators (ICDs) or vena cava filters.
- Subjects with coagulation disorders or bleeding disorders including gastric ulcers, who are unable to take antiplatelet or anticoagulant therapy
- Subjects with an intra-cardiac mass, tumor, clots or vegetation
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- 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.
- Presence of conduction abnormality 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
- Religious or other beliefs which would prevent subjects from following all physician directed instructions or prevent compliance with protocol required medications and follow-ups.
- Hemodynamic instability or shock
- History of diabetes requiring treatment with insulin
- Additional Exclusion Criteria for Cryptogenic Stroke Subjects:
- History of stroke or TIA within the past 14 days
- Source of stroke other than paradoxical embolization
- Additional Exclusion Criteria for Migraine Subjects:
- Seizure disorder
- Other organic central nervous system disease
- Headache as a result of traumatic head or neck injury
- Evidence of alcohol, drug or substance abuse within the previous year
Trial locations and contacts
1 site in 1 country.
Germany1 site
Cardiovascular Center Frankfurt Sankt katharinen
Frankfurt, 60389
About this study
Official title: Feasibility Study of the 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 efficacy of the PFX Closure System when utilized for patent foramen ovale (PFO) in patients suffering from cryptogenic stroke (undetermined cause of stroke), transient ischemic attack (brief neurological dysfunction), 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; we propose to use a non-implantable system to safely effect closure.
- Conditions
- Foramen Ovale, Patent
- 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 intracardiac echocardiography (ICE) acutely post procedure
Secondary outcomes (4)
PFO closure as measured by TEE or transthoracic echocardiography (TTE) at 30 days, 3 or 6 months and 12 months post procedure
Adverse event (AE) rates for all subjects
New conduction abnormality rate through final follow-up
Measurement of migraine severity or frequency at 6 and 12 months post procedure for subjects enrolled due to diagnosis of migraine
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 startOct 2005
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foramen Ovale, PatentStudies 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
- 60 participants
Sponsor and investigators
- Lead sponsor
- Cierra
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Horst Sievert, MD, Principal investigator, Cardio Vasculares Centrum - Sankt Katharinen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196040
- Sponsor's protocol ID
- 2005-002
- Status last verified
- Dec 2007
- First submitted
- 12 Sep 2005
- 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
- Feasibility Study of the PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness
- ClinicalTrials.gov ID
- NCT00196040
- Acronym / sponsor ID
- 2005-002
- Conditions
- Foramen Ovale, Patent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- CierraIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Study completion
- Nov 2007 (actual)
- 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 and efficacy of the PFX Closure System when utilized for patent foramen ovale (PFO) in patients suffering from cryptogenic stroke (undetermined cause of stroke), transient ischemic attack (brief neurological dysfunction), 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; 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
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 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 transcranial Doppler (TCD) and peri-operative echocardiography or ultrasound.
- Subjects with one or more of the following:
- Negative pregnancy test in women who are of child-bearing potential
- Signed Informed Consent form
Key exclusion criteria (20 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 defect(s) or fenestrations which allow shunting
- Presence of implanted cardiac valves, pacemakers, cardioverters/defibrillators (ICDs) or vena cava filters.
- Subjects with coagulation disorders or bleeding disorders including gastric ulcers, who are unable to take antiplatelet or anticoagulant therapy
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 intracardiac echocardiography (ICE) acutely post procedure
4 secondary outcomes
PFO closure as measured by TEE or transthoracic echocardiography (TTE) at 30 days, 3 or 6 months and 12 months post procedure
Adverse event (AE) rates for all subjects
New conduction abnormality rate through final follow-up
Measurement of migraine severity or frequency at 6 and 12 months post procedure for subjects enrolled due to diagnosis of migraine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2007.
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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 Katharinen
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 Foramen Ovale, Patent, 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 12 inclusion and 20 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: finished, 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 intracardiac echocardiography (ICE) 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 24 Dec 2007.