A feasibility study of 30-50 patients to evaluate the clinical response to Patent Foramen Ovale (PFO) closure using Coherex FlatStentTM EF PFO Closure System (EF is part of the trade mark name and stands for Enhanced Foam) in Obstructive Sleep Apnea (OSA) patients with significant right-to-left shunting and oxygen desaturation as demonstrated during sleep studies.

Coherex Medical Inc.0 sites50 target enrollmentMarch 2, 2010

ConditionsSignificant oxygen desaturation associated with right-to-left shunts through a PFO in Obstructive Sleep Apnea(OSA) patients Cardiovascular - Other cardiovascular diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Significant oxygen desaturation associated with right-to-left shunts through a PFO in Obstructive Sleep Apnea(OSA) patients
Sponsor: Coherex Medical Inc.
Enrollment: 50
Status: Recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 2, 2010

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Coherex Medical Inc.

Eligibility Criteria

Inclusion Criteria

•Diagnosis of OSA and a polysomnogram within the past year that demonstrated an apnea index \> 20 seconds (AI20\) of greater than 5 and an oxygen desaturation index \> 6% (ODI6\) of greater than 5 associated with apnic events. Patients willing to under go transcranial doppler (TCD) and demonstrates a Grade IV or Grade V right\-to\-left shunt. Patients must demonstrate a PFO amenable to transcatheter closure with the Coherex FlatStentTM EF PFO Closure System.

Exclusion Criteria

•Candidates will be excluded from the study if ANY of the following conditions apply: 1\. Long\-term requirement for anti\-platelet therapy, anticoagulation, or coagulopathy. 2\. Contraindication and/or allergy to aspirin, clopidogrel, Nitinol, Dacron, polyurethane, nickel, stainless steel or other stent materials. 3\. Concurrent enrollment in another clinical study. 4\. Body mass index \> 40\. 5\. Botox treatment within the past 90 days. 6\. Other known structural heart disease, coronary artery disease, or atrial fibrillation. 7\. Chronic liver disease, kidney disease, or organ failure. 8\. Auto\-immune disease. 9\. Psychiatric illness, which in the investigator’s opinion, will interfere with completion of the study. 10\. Degenerative neurologic disorders. 11\. Any known active bacterial infection. 12\. Malignancy or other illness with a life expectancy less than two years. 13\. Pregnancy or desire to become pregnant during course of study. 14\. Right\-to\-left shunt besides PFO detected prior to enrollment. 15\.Uncontrolled hypertension defined as blood pressure greater than140/90 mmHg. 16\. Immunosuppressive therapy. 17\.Diabetes requiring insulin or blood glucose greater than 200 mg/deciliter on oral diabetic medications. 18\. Concomitant pulmonary disorder (chronic obstructive pulmonary disorder \[COPD], asthma, etc.) requiring treatment. 19\. Any medical disorder that would interfere with study completion. 20\. Known severe pulmonary hypertension (requiring medication). 21\.Patients who have had a major stroke within the past two months or a minor stroke within the past two weeks (see National Institutes of Health (NIH) Stroke Scale). 22\. Patients who require a transseptal puncture to access the left atrium. 23\. Patients with known sustained arrhythmia.