09k003: Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (PFO) Closure Device and Its Application System
Study Details
Study Description
Brief 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). 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Outcome Measures
Primary Outcome Measures
- Number of Participants With a Successful Implantation. [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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
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Presenting with neurological symptoms and at least one of the following clinical circumstances:
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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
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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
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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.
Exclusion Criteria:
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PFO dimensions exceeding Inclusion criterium 5)
-
Active endocarditis
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Presence of an infectious disease
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Vascular anatomy unable to accommodate the appropriate-sized sheath for device introduction
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Current arrhythmia, or history of arrhythmia
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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)
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Heart abnormality other than PFO
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Accessory atrial defects
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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
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Known allergy to nickel
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Known allergy to contrast agents
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Cancerogenic disease or malignant tumor, or other severe disease
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Intracardiac mass or vegetation
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Thrombus at the intended site of implant or documented evidence of venous thrombus in the vessel to which access to the defect is gained
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Unable to tolerate Aspirin or Clopidogrel, and/or antibiotic prophylaxis for at least three months following the procedure
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Pregnant or breast feeding female patients
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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
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Subjects who are imprisoned (according to MPG § 20.3)
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Patients who are lawfully kept in an institution
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cardio-Vascular Centre, Sankt Kathrinen | Frankfurt | Germany | 60389 |
Sponsors and Collaborators
- pfm medical ag
- MDT Medical Device Testing GmbH
Investigators
- Principal Investigator: Horst Sievert, Prof. Dr., Cardio-Vascular Centre, Sankt Kathrinen, Frankfurt, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 09k003
Study Results
Participant Flow
| Recruitment Details | The recruitment period was set between June 2009 and July 2010 at a single medical clinic. |
|---|---|
| Pre-assignment Detail | No enrolled participants were excluded from the trial. |
| Arm/Group Title | Nit-Occlud® PFO Implantation Group |
|---|---|
| Arm/Group Description | Patients suffering from PFO and suitable for closure of the defect with the Nit-Occlud® PFO Closure Device |
| Period Title: Overall Study | |
| STARTED | 63 |
| COMPLETED | 61 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | Nit-Occlud® PFO |
|---|---|
| Arm/Group Description | |
| Overall Participants | 63 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
61
96.8%
|
| >=65 years |
2
3.2%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
45.7
(11.2)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
26
41.3%
|
| Male |
37
58.7%
|
| Region of Enrollment (participants) [Number] | |
| Germany |
63
100%
|
Outcome Measures
| Title | Number of Participants With a Successful Implantation. |
|---|---|
| Description | 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. |
| Time Frame | 6 weeks ± 2 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Nit-Occlud® PFO |
|---|---|
| Arm/Group Description | |
| Measure Participants | 63 |
| Number [participants] |
62
98.4%
|
Adverse Events
| Time Frame | Adverse Events were observed for each patient during a 6 week FU period (6 weeks +- 2 weeks). Adverse events were judged by the relationship to the investigational device | |
|---|---|---|
| Adverse Event Reporting Description | No AE led to discontinuation of the study. Causal relationship to the device was not ruled out in 19 AEs. Within these, for 15 AEs the relationship was recorded as unknown, 2 AEs were recorded as possibly related, and 2 AEs were recorded as related. All device related AEs were reported as of mild intensity. | |
| Arm/Group Title | Nit-Occlud® PFO | |
| Arm/Group Description | ||
All Cause Mortality |
||
| Nit-Occlud® PFO | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Nit-Occlud® PFO | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/63 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Nit-Occlud® PFO | ||
| Affected / at Risk (%) | # Events | |
| Total | 19/63 (30.2%) | |
| Cardiac disorders | ||
| Cardiac General | 5/63 (7.9%) | 5 |
| Cardiac Arrhythmia | 3/63 (4.8%) | 3 |
| Other | 2/63 (3.2%) | 2 |
| General disorders | ||
| Constitutional Symptoms | 3/63 (4.8%) | 3 |
| Pain | 1/63 (1.6%) | 1 |
| Nervous system disorders | ||
| Neurology | 4/63 (6.3%) | 4 |
| Respiratory, thoracic and mediastinal disorders | ||
| Pulmonary/Upper respiratory | 1/63 (1.6%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Christof Schmeer |
|---|---|
| Organization | pfm medical ag |
| Phone | +49 6873 9011 ext 41 |
| christof.schmeer@pfmmedical.com |
- 09k003