Coherex-PFO-Sleep Hypoxia: A multi-center study to determine the response to closure of patent foramen ovale (PFO) with the Coherex FlatStentTM EF PFO Closure System (EF is part of the trade mark name and stands for Enhanced Foam) in patients diagnosed with PFO and significant oxygen desaturation in obstructive sleep apnea (OSA)

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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000184077

Acronym

COHEREX-PFO-SLEEP-HYPOXIA

Enrollment

Registered

2010-03-02

Start date

2009-08-12

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The Coherex-PFO-Sleep Hypoxia is a multi-center study for up to 50 patients to determine the response to closure of patent foramen ovale (PFO) with the Coherex FlatStentTM EF PFO Closure System in patients diagnosed with PFO and significant oxygen desaturation in obstructive sleep apnea (OSA)

Interventions

Coherex FlatStentTM EF Patent Foramen Ovale (PFO) Closure System is a permanent implant placed percutaneously by an interventional cardiologist into a patent foramen ovale to close the congenital defect. The procedure takes approximately 30 minutes. Patients will be observed for 6 months after the permanent device placement.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

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.

Outcome results