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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAristides Plaitis

About this trial

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.

Eligibility criteria

Qualifiers

Adult patients undergoing TAVI or M-TEER

Ability to undergo polysomnography

Provision of written informed consent

Disqualifiers

Inability to undergo sleep study (polysomnography)

Inability to complete follow-up at 6 months

Cognitive impairment (e.g., dementia)

Refusal to participate

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

150 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Aristides Plaitis

Lead sponsor

Hippocration General Hospital

Sponsor institution