Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (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.

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Key information

Conditions

Foramen Ovale, Patent Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Catheterization Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardio-Vascular Centre, Sankt Kathrinen

Frankfurt, 60389, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nit-Occlud® PFO

Device

Transcatheter implantation of a PFO occluder (Nitinol double Umbrella)

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

pfm medical gmbh

Industry

Collaborators

MDT Medical Device Testing GmbH

Registry information

Official study 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.

Acronym: 09k003

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Aug 28, 2009
Registry last updated: Jun 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed