Impact Of Closure Of Patent Foramen Ovale On Apnoea-Hypopnoea-Index, Nocturnal Hypoxemia And Systemic Vascular Function In Patients With Obstructive Sleep Apnoea

Insel Gruppe AG, University Hospital Bern

Status

Completed

Conditions

Obstructive Sleep Apnea

Treatments

Device: PFO Closure

Study type

Interventional

Funder types

Other

Identifiers

NCT01780207

066/10

Details and patient eligibility

About

The purpose of this study in patients with obstructive sleep apnoea (OSA) and concomitant patent foramen ovale (PFO) is to assess the impact of percutaneous PFO closure on nocturnal hypoxemia and apnea/hypopnea, pulmonary and systemic artery pressure, endothelial function and arterial stiffness.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with newly diagnosed moderate to severe OSA
Age > 17 years
Written informed consent for study participation.

Exclusion criteria

Patients with other pulmonary disease associated with oxygen desaturation (other than obesity-associated pulmonary restriction)
Patients with central sleep apnea syndrome
Patients with other causes of pulmonary hypertension
Intracardiac shunt other than via PFO
Severe valvular heart disease
Abnormal left ventricular (LV) systolic function (ejection fraction <50%)
Obesity with BMI > 40
Contraindication to TOE
Severe pulmonary arterial hypertension (mean pulmonary artery pressure > 45 mmHg)