Foramen Ovale, Patent09k003NCT00968032
Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (PFO) Closure Device and Its Application System
A study testing Nit-Occlud® PFO in people with Foramen Ovale, Patent and Heart Catheterization, run by pfm medical gmbh at 1 site in Germany.
Trial summary
The foramen ovale is an opening in the interatrial septum. It results from an incomplete coverage of the ostium secundum. In 10 to 24% of the general population incomplete fibrosis of the interatrial septum is a clinical finding and is defined as a patent foramen ovale (PFO). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Foramen Ovale, Patent, Heart Catheterization, Heart Septal Defects, Atrial
- What is being tested?
- Nit-Occlud® PFO
- Type of treatment
- Medical device
- How many people
- 63 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis of patent foramen ovale (PFO)
- Age between 18 and 65 years of both gender
- Ability to give written informed consent after being told the potential benefits and risks of entering the trial to understand the planned clinical study and able to participate in all follow-up procedures
- Signed informed consent
- Presenting with neurological symptoms and at least one of the following clinical circumstances:
- Diagnosis of cryptogenic stroke based on clinical neurological examination
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- Diagnosis of a transient ischemic attack (TIA) based on clinical neurological examination
- PFO defect with or without atrial septal aneurysm of a balloon stretched diameter less than 18 mm. PFO tunnel length less than 10 mm in TEE
- Mental and physical ability of patient to follow the protocol according to compliance to time schedule, treatment plan,completion of CRF pages and further study procedures.
Who cannot join
- PFO dimensions exceeding Inclusion criterium 5)
- Active endocarditis
- Presence of an infectious disease
- Vascular anatomy unable to accommodate the appropriate-sized sheath for device introduction
- Current arrhythmia, or history of arrhythmia
- Prior cardiac surgery, including implantation of active and non-active cardiac device (coronary stent is allowed)
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- Confinement to bed (because of higher potential for clot formation)
- Heart abnormality other than PFO
- Accessory atrial defects
- Participation in an investigational drug or device trial within 30 days prior to selection, or current inclusion in any other clinical trial or research project
- Known allergy to nickel
- Known allergy to contrast agents
- Cancerogenic disease or malignant tumor, or other severe disease
- Intracardiac mass or vegetation
- Thrombus at the intended site of implant or documented evidence of venous thrombus in the vessel to which access to the defect is gained
- Unable to tolerate Aspirin or Clopidogrel, and/or antibiotic prophylaxis for at least three months following the procedure
- Pregnant or breast feeding female patients
- Subjects who, in the opinion of the investigator, will be inappropriate for inclusion into this trial or will not comply with requirements of the study
- Subjects who are imprisoned (according to MPG § 20.3)
- Patients who are lawfully kept in an institution
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center Non-comparative, Prospective Interventional Clinical Investigation on the Procedural Success and Safety of the Nit-Occlud® PFO Closure Device and Its Application System.
The foramen ovale is an opening in the interatrial septum. It results from an incomplete coverage of the ostium secundum. In 10 to 24% of the general population incomplete fibrosis of the interatrial septum is a clinical finding and is defined as a patent foramen ovale (PFO). The Nit-Occlud® PFO umbrella is a permanent implant for closing PFOs that is implanted in the PFO using minimally invasive catheter technology. The umbrella is made from Nitinol, a material with superelastic properties, which, in its relaxed state, has the form of a double umbrella. This is a single-center, non-comparative, prospective interventional clinical investigation involving 1 center in Germany to assess the effectiveness, safety and practicability of implantation of the Nit-Occlud PFO® Closure Device.
- Being tested
- Nit-Occlud® PFO
- Keywords
- PFO, Patent Foramen Ovale
- Medical subject headings
- Foramen Ovale, Patent, Heart Septal Defects, Atrial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nit-Occlud® PFODevice
Transcatheter implantation of a PFO occluder (Nitinol double Umbrella)
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Successful Implantation.
The implantation of the device under investigation in a single patient is defined as successful if delivery, placement and release of the device in a stable position is successful. The value will be compared to the number of patient enrolled.
Measured: 6 weeks ± 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- pfm medical gmbh
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MDT Medical Device Testing GmbH
- Investigators
- Horst Sievert, Prof. Dr., Principal investigator, Cardio-Vascular Centre, Sankt Kathrinen, Frankfurt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968032
- Sponsor's protocol ID
- 09k003
- Acronym
- 09k003
- Status last verified
- May 2011
- First submitted
- 27 Aug 2009
- Last updated
- 2 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Non-comparative, Prospective Interventional Clinical Investigation on the Procedural Success and Safety of the Nit-Occlud® PFO Closure Device and Its Application System.
- ClinicalTrials.gov ID
- NCT00968032
- Acronym / sponsor ID
- 09k003 / 09k003
- Keywords
- PFO, Patent Foramen Ovale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- pfm medical gmbhIndustry (pharma, biotech, devices)
- Collaborators
- MDT Medical Device Testing GmbH
- Study start
- Jul 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 28 Aug 2009 (estimated)
- Results
- Posted 9 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The foramen ovale is an opening in the interatrial septum. It results from an incomplete coverage of the ostium secundum. In 10 to 24% of the general population incomplete fibrosis of the interatrial septum is a clinical finding and is defined as a patent foramen ovale (PFO). The Nit-Occlud® PFO umbrella is a permanent implant for closing PFOs that is implanted in the PFO using minimally invasive catheter technology. The umbrella is made from Nitinol, a material with superelastic properties, which, in its relaxed state, has the form of a double umbrella. This is a single-center, non-comparative, prospective interventional clinical investigation involving 1 center in Germany to assess the effectiveness, safety and practicability of implantation of the Nit-Occlud PFO® Closure Device.
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 (9 listed)
- Diagnosis of patent foramen ovale (PFO)
- Age between 18 and 65 years of both gender
- Ability to give written informed consent after being told the potential benefits and risks of entering the trial to understand the planned clinical study and able to participate in all follow-up procedures
- Signed informed consent
- Presenting with neurological symptoms and at least one of the following clinical circumstances:
Key exclusion criteria (20 listed)
- PFO dimensions exceeding Inclusion criterium 5)
- Active endocarditis
- Presence of an infectious disease
- Vascular anatomy unable to accommodate the appropriate-sized sheath for device introduction
- Current arrhythmia, or history of arrhythmia
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 |
|---|---|---|
| Nit-Occlud® PFOTranscatheter implantation of a PFO occluder (Nitinol double Umbrella) | Device | – |
Primary outcome
Number of Participants With a Successful Implantation.
Time frame: 6 weeks ± 2 weeks
The implantation of the device under investigation in a single patient is defined as successful if delivery, placement and release of the device in a stable position is successful. The value will be compared to the number of patient enrolled.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, Prof. Dr. principal investigator
Cardio-Vascular Centre, Sankt Kathrinen, 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 Nit-Occlud® PFO in people with Foramen Ovale, Patent and Heart Catheterization, run by pfm medical gmbh 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 9 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 2 Jun 2011. 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?
Yes. Results are posted in the registry (first posted 9 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With a Successful Implantation. (time frame: 6 weeks ± 2 weeks). 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 2 Jun 2011.