PFOParadigm IVNCT00529945
PFx Closure System in Subjects With Cryptogenic Stroke, TIA, Migraine or Decompression Illness
A study testing PFx Closure System in people with PFO and Stroke, run by Cierra at 1 site in Germany.
Trial summary
The primary object of this study is to demonstrate the continued 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
- PFO, Stroke, Transient Ischemic Attack
- What is being tested?
- PFx Closure System
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2007to 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 18 to 65 years old
- PFO with one or more of:
- Cryptogenic stroke,
- TIA or embolism,
- History of severe migraine headaches, or
- History of severe decompression illness.
Who cannot join
- In appropriate anatomy (vascular or cardiac) or inappropriate medical condition for PFO closure and study medications.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Cardiovascular Center Frankfurt Sankt katharinen
Frankfurt, 60389
About this study
Official title: The Paradigm IV Trial - PFx Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness
The primary object of this study is to demonstrate the continued 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.
- Conditions
- PFO, Stroke, Transient Ischemic Attack, Migraine, Decompression Illness
- Being tested
- PFx Closure System
- Keywords
- PFO, Stroke, Transient Ischemic Attack, Migraine, Decompression Illness
- Medical subject headings
- Stroke, Ischemic Attack, Transient, Migraine Disorders
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 at 6 months post procedure.
Measured: 6 months post procedure
Secondary outcomes (1)
PFO closure at 30 days and 12 months post procedure. AE event rate for all subjects. Measurement of migraine severity or frequency at 6 and 12 months post procedure for subjects enrolled due to diagnosis of migraine.
Measured: 30 days; 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 posted14 Sep 2007 (estimated)
- Study startAug 2007
- 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 PFOStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cierra
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Horst Sievert, MD, Principal investigator, Cardiovascular Center Frankfurt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529945
- Sponsor's protocol ID
- CA0012
- Acronym
- Paradigm IV
- Status last verified
- Dec 2007
- First submitted
- 12 Sep 2007
- Last updated
- 21 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Paradigm IV Trial - PFx Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness
- ClinicalTrials.gov ID
- NCT00529945
- Acronym / sponsor ID
- Paradigm IV / CA0012
- Conditions
- PFO, Stroke, Transient Ischemic Attack, Migraine, Decompression Illness
- Keywords
- PFO, Stroke, Transient Ischemic Attack, Migraine, Decompression Illness
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- CierraIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Study completion
- Dec 2007 (estimated)
- First posted
- 14 Sep 2007 (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 object of this study is to demonstrate the continued 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.
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 (6 listed)
- Age 18 to 65 years old
- PFO with one or more of:
Key exclusion criteria (1 listed)
- In appropriate 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 Closure System | Device | – |
Primary outcome
PFO closure at 6 months post procedure.
Time frame: 6 months post procedure
1 secondary outcome
PFO closure at 30 days and 12 months post procedure. AE event rate for all subjects. Measurement of migraine severity or frequency at 6 and 12 months post procedure for subjects enrolled due to diagnosis of migraine.
Time frame: 30 days; 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 21 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
Cardiovascular Center Frankfurt, Germany
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 PFO and Stroke, 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 6 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 21 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?
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 at 6 months post procedure. (time frame: 6 months 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 21 Dec 2007.