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Close Obstructive Sleep Apnea (OSA) Trial

NCT06113562 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-03-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

PFO closure

The participants will receive a onetime closure of a small hole in heart. The procedure usually takes up to an hour. The procedure is done with local anesthesia and conscious sedation. A catheter is inserted into a vein in upper thigh and threaded to heart to deploy the closure device. Either Gore septal occluder or Amplatzer PFO occluder

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Eduardo de Marchena, MD · University of Miami

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2025-02-11
Completion
2025-02-11

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06113562 on ClinicalTrials.gov