RecruitingNCT07520656

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

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


Sponsor

Aristides Plaitis

Enrollment

150 participants

Start Date

Jul 20, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria3

  • Adult patients undergoing TAVI or M-TEER
  • Ability to undergo polysomnography
  • Provision of written informed consent

Exclusion Criteria4

  • Inability to undergo sleep study (polysomnography)
  • Inability to complete follow-up at 6 months
  • Cognitive impairment (e.g., dementia)
  • Refusal to participate

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Locations(1)

Hippocratio General Hospital of Athens

Athens, Attica, Greece

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NCT07520656


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