Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (PFO) Closure Device and Its Application System - Full Text View

Sponsor:	pfm medical ag
Collaborator:	MDT Medical Device Testing GmbH
Information provided by:	pfm medical ag
ClinicalTrials.gov Identifier:	NCT00968032

Purpose

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	Intervention
Foramen Ovale, Patent Heart Catheterization Heart Septal Defects, Atrial	Device: Nit-Occlud® PFO

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Head Lice

U.S. FDA Resources

Further study details as provided by pfm medical ag:

Primary Outcome Measures:

Number of Participants With a Successful Implantation. [ Time Frame: 6 weeks ± 2 weeks ] [ Designated as safety issue: Yes ]
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.

Enrollment:	63
Study Start Date:	July 2009
Study Completion Date:	June 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Transcatheter implantation of a PFO occluder (Nitinol double Umbrella)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
Presenting with neurological symptoms and at least one of the following clinical circumstances:
- Diagnosis of cryptogenic stroke based on clinical neurological examination
- 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.

Exclusion Criteria:

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)
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00968032

Locations

Germany
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

More Information

No publications provided

Responsible Party:	Christof Schmeer head of quality assurance pfm group, pfm medical ag
ClinicalTrials.gov Identifier:	NCT00968032 History of Changes
Other Study ID Numbers:	09k003
Study First Received:	August 27, 2009
Results First Received:	January 27, 2011
Last Updated:	May 30, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by pfm medical ag:

PFO
Patent Foramen Ovale

Additional relevant MeSH terms:

Foramen Ovale, Patent
Heart Septal Defects
Heart Septal Defects, Atrial
Heart Defects, Congenital

Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on February 09, 2012