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Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (PFO) Closure Device and Its Application System (09k003)

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Nit-Occlud® PFO
Sponsored by
pfm medical ag
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Foramen Ovale, Patent focused on measuring PFO, Patent Foramen Ovale

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of patent foramen ovale (PFO)

  1. Age between 18 and 65 years of both gender
  2. 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
  3. Signed informed consent

  4. 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
  5. 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
  6. 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:

  1. PFO dimensions exceeding Inclusion criterium 5)
  2. Active endocarditis
  3. Presence of an infectious disease
  4. Vascular anatomy unable to accommodate the appropriate-sized sheath for device introduction
  5. Current arrhythmia, or history of arrhythmia
  6. Prior cardiac surgery, including implantation of active and non-active cardiac device (coronary stent is allowed)
  7. Confinement to bed (because of higher potential for clot formation)
  8. Heart abnormality other than PFO
  9. Accessory atrial defects
  10. 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
  11. Known allergy to nickel
  12. Known allergy to contrast agents
  13. Cancerogenic disease or malignant tumor, or other severe disease
  14. Intracardiac mass or vegetation
  15. Thrombus at the intended site of implant or documented evidence of venous thrombus in the vessel to which access to the defect is gained
  16. Unable to tolerate Aspirin or Clopidogrel, and/or antibiotic prophylaxis for at least three months following the procedure
  17. Pregnant or breast feeding female patients
  18. 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
  19. Subjects who are imprisoned (according to MPG § 20.3)
  20. Patients who are lawfully kept in an institution

Sites / Locations

  • Cardio-Vascular Centre, Sankt Kathrinen

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 27, 2009
Last Updated
May 30, 2011
Sponsor
pfm medical ag
Collaborators
MDT Medical Device Testing GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00968032
Brief Title
Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (PFO) Closure Device and Its Application System
Acronym
09k003
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
pfm medical ag
Collaborators
MDT Medical Device Testing GmbH

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foramen Ovale, Patent, Heart Catheterization, Heart Septal Defects, Atrial
Keywords
PFO, Patent Foramen Ovale

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Nit-Occlud® PFO
Intervention Description
Transcatheter implantation of a PFO occluder (Nitinol double Umbrella)
Primary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Horst Sievert, Prof. Dr.
Organizational Affiliation
Cardio-Vascular Centre, Sankt Kathrinen, Frankfurt, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardio-Vascular Centre, Sankt Kathrinen
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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