Heart Hole Closure for Obstructive Sleep Apnea

Overseen By Eduardo de Marchena, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Trial Summary

What is the purpose of this trial?

The aim of this study is to evaluate the benefits of patent foramen ovale (PFO) closure on patients with obstructive sleep apnea (OSA) and persistent hypoxia despite optimal therapy.

Research Team

Eduardo de Marchena, MD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for people with severe obstructive sleep apnea (OSA) who still have low oxygen levels at night even after the best standard treatments. They must also have a heart condition called patent foramen ovale (PFO), confirmed by a special heart ultrasound.

Inclusion Criteria

I have severe sleep apnea with an AHI over 30 and low oxygen levels at night.

My heart has a hole between its upper chambers, confirmed by an echo.

Exclusion Criteria

Pregnant individuals or those who become pregnant during the course of the study will be automatically withdrawn.

You are not able to take aspirin, clopidogrel, or ticagrelor.

Treatment Details

Interventions

• PFO closure

Trial Overview The study is testing if closing the PFO in the heart can help improve OSA symptoms and nighttime oxygen levels in patients who haven't gotten better with usual treatments.

Participant Groups

Group I: Persistent hypoxemia after Obstructive sleep apnea group Experimental Treatment 1 Intervention

Participants will receive Patent Foramen Ovale (PFO) closure and followed until repeat sleep apnea testing up to 6 months.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+