Impact of Transcatheter Aortic Valve Implantation and Mitral Valve Repair on Sleep-Disordered Breathing

N/ARecruitingNCT07520656

Aristides Plaitis150 enrolled

Overview

This prospective observational study aims to investigate the impact of transcatheter aortic valve implantation (TAVI) and transcatheter mitral valve edge-to-edge repair (M-TEER) on sleep-disordered breathing (SDB) in patients with significant valvular heart disease. Patients undergoing TAVI or M-TEER will be evaluated with full polysomnography prior to the intervention and at 6 months follow-up. Changes in sleep parameters, including apnea-hypopnea index (AHI), central and obstructive apnea indices, oxygen desaturation, and sleep architecture, will be assessed. In addition, the study will explore the association between changes in SDB and echocardiographic as well as arrhythmic parameters. The findings are expected to improve the understanding of the interaction between valvular heart disease and SDB and to identify potential benefits of transcatheter interventions on sleep-related outcomes.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Sleep-disordered Breathing (SDB)Aortic Valve Stenosis Mitral Valve Regurgitation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients undergoing TAVI or M-TEER * Ability to undergo polysomnography * Provision of written informed consent Exclusion Criteria: * Inability to undergo sleep study (polysomnography) * Inability to complete follow-up at 6 months * Cognitive impairment (e.g., dementia) * Refusal to participate

Outcomes

Primary Outcomes

Change in AHI

Assessment of change in AHI from baseline to 6 months after transcatheter valve intervention, as measured by full polysomnography.