Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Adult patients undergoing TAVI or M-TEER
- Ability to undergo polysomnography
- Provision of written informed consent
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
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Trial Site Locations
Total: 1 location
1
Hippocratio General Hospital of Athens
Athens, Attica, Greece, 11527
Actively Recruiting
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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