Paradigm I Clinical Trial: Study of the PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemia Attack or Paradoxical Embolism
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by Cierra.
Recruitment status was Active, not recruiting
Information provided by:
First received: September 12, 2005
Last updated: November 27, 2006
Last verified: November 2006
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.
Patent Foramen Ovale
Device: PFX Closure System
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Feasibility Study of the PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemia Attack or Paradoxical Embolism
Primary Outcome Measures:
- PFO closure as measured by transesophageal echocardiography (TEE) or transcranial Doppler (TCD) acutely post procedure
Secondary Outcome Measures:
- 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
| Estimated Enrollment:
| Study Start Date:
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.
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00196027
|CardioVascular Center, Sankt katharinen
|FrankFurt/Main, Germany |
||Horst Sievert, MD
||Cardio Vasculares Centrum - Sankt Katharien
No publications provided
History of Changes
|Other Study ID Numbers:
||2005-001 version 1
|Study First Received:
||September 12, 2005
||November 27, 2006
||Germany: Federal Institute for Drugs and Medical Devices
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 17, 2013
Foramen Ovale, Patent
Heart Septal Defects, Atrial
Ischemic Attack, Transient
Embolism and Thrombosis
Heart Septal Defects
Heart Defects, Congenital
Central Nervous System Diseases
Nervous System Diseases