Actively Recruiting

Age: 18Years +
All Genders
NCT07520656

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

Led by Aristides Plaitis · Updated on 2026-04-09

150

Participants Needed

1

Research Sites

214 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients undergoing TAVI or M-TEER
  • Ability to undergo polysomnography
  • Provision of written informed consent
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hippocratio General Hospital of Athens

Athens, Attica, Greece, 11527

Actively Recruiting

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Research Team

A

Aristides Plaitis, MD, MSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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