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)

This study is testing whether closing a small hole in the heart called a patent foramen ovale (PFO) — a natural opening between the upper chambers of the heart that normally closes after birth but sometimes stays open — can improve oxygen levels during sleep in people with obstructive sleep apnoea (OSA). OSA causes people to repeatedly stop breathing during sleep, and a PFO may worsen the drop in oxygen levels that occurs during these episodes. You may be eligible if: - You are between 18 and 65 years old - You have a confirmed diagnosis of obstructive sleep apnoea with significant oxygen drops during sleep - A special ultrasound test (transcranial Doppler) has shown you have a Grade IV or V right-to-left shunt through a PFO - You have a PFO that can be closed with the specific device used in this study You may NOT be eligible if: - You require long-term blood thinners or have a clotting disorder - You are allergic to aspirin, clopidogrel, or materials in the device (such as nickel or Dacron) - Your BMI is over 40 - You have other significant heart disease, coronary artery disease, or atrial fibrillation - You have chronic liver or kidney disease - You are pregnant or wish to become pregnant during the study - You have had a major stroke in the past 2 months or a minor stroke in the past 2 weeks - You have uncontrolled high blood pressure, insulin-dependent diabetes, or significant lung disease Talk to your doctor about whether this trial might be right for you.