Paradigm I Clinical Trial: Study of the PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemia Attack or Paradoxical Embolism

November 27, 2006 updated by: Cierra

Feasibility Study of the PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemia Attack or Paradoxical Embolism

The primary objective of this study is to demonstrate the safety of the PFX Closure System when utilized for patients with patent foramen ovale (PFO) suffering from cryptogenic stroke, transient ischemic attacks or paradoxical embolism.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patent Foramen Ovale has been implicated in the etiology of paradoxical embolism, cryptogenic stroke, transient ischemic attack (TIA), and right to left gas embolism in severe decompression illness. An association between patent foramen ovale and severe migraine headaches has also been reported. Several implantable devices are being used for percutaneous closure of patent foramen ovale; we propose to use a non-implantable system to safely effect closure.

Study Type

Interventional

Enrollment

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • FrankFurt/Main, Germany
        • CardioVascular Center, Sankt katharinen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is between 18 and 65 years old.
  • Documented patent foramen ovale as determined by positive micro bubble study demonstrating right to left shunt and/or anatomic detection and functional assessment by pre-operative TCD and peri-operative echocardiography or ultrasound.
  • Subjects with a history of cryptogenic stroke, transient ischemic attack or paradoxical embolism due to presumed paradoxical embolism through a PFO.
  • Negative pregnancy test in women who are of child-bearing potential.
  • Signed Informed Consent form.

Exclusion Criteria:

  • Presence of thrombus at the intended site of closure, in left atrial appendage, or documented evidence of venous thrombus in the vessels through which access to the PFO is gained.
  • Active endocarditis, or other infections producing a bacteremia.
  • Presence of atrial septal defects or fenestrations which allow right-to-left shunting.
  • Presence of implanted cardiac valves, pacemaker, implantable cardioverters/defibrillators (ICDs) or vena cava filters.
  • Subjects with an intra-cardiac mass, tumor, clot or vegetation.
  • Large, redundant atrial septal aneurysm that would prohibit adequate device access to the PFO or closure of the PFO, in the judgment of the investigator. A coexisting redundant atrial septal aneurysm is considered large if it prohibits the ability of the operator to adequately achieve vacuum suction necessary to achieve PFO closure.
  • Presence of arrhythmia requiring pharmacologic or electrical therapy intervention or 1st degree block.
  • Current enrollment in any investigational trial(s) using devices implanted in the vascular system or enrolled in any experimental drug study(ies) within three months of study entry.
  • History of stroke or TIA within the past 14 days.
  • Source of stroke other than paradoxical embolization.
  • Hemodynamic instability or shock.
  • Hypercoagulable disorder.
  • Subjects with coagulation disorders who are unable to take antiplatelet or anticoagulant therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
PFO closure as measured by transesophageal echocardiography (TEE) or transcranial Doppler (TCD) acutely post procedure

Secondary Outcome Measures

Outcome Measure
PFO closure as measured by TEE or TCD at 30 days post procedure
Neurological death and adverse event (AE) rates for all subjects through 30 day follow-up
New arrhythmia rate through 30 day follow-up. For any subjects with new arrhythmia, arrhythmia status will also be evaluated at a follow-up visit from 3 to 6 months post procedure
PFO closure rate at 3 to 6 months for any subject not demonstrating complete closure at the 30 day follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cierra

Investigators

  • Principal Investigator: Horst Sievert, MD, Cardio Vasculares Centrum - Sankt Katharien

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

November 29, 2006

Last Update Submitted That Met QC Criteria

November 27, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-001 version 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Patent Foramen Ovale

Clinical Trials on PFX Closure System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe