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

Study acronym: SLEEP-VALVE
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07520656
Lead Sponsor Aristides Plaitis
Conditions
(from sponsor)		 Sleep-disordered Breathing (SDB), Aortic Valve Stenosis, Mitral Valve Regurgitation
Related terms Aortic Valve Stenosis, Cockayne Syndrome, Heart Valve Diseases, Mitral Valve Insufficiency, Sleep Apnea Syndromes, Sleep Apnea, Central, Sleep Apnea, Obstructive
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov