Actively Recruiting
Impact of Transcatheter Aortic Valve Implantation and Transcatheter Mitral Valve Edge-to-Edge Repair on Sleep-Disordered Breathing
Led by Aristides Plaitis · Updated on 2026-04-09
150
Participants Needed
1
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring how transcatheter aortic valve implantation (TAVI) and transcatheter mitral valve edge-to-edge repair (M-TEER) affect sleep-disordered breathing (SDB) in adults with serious heart valve problems like aortic stenosis and mitral regurgitation. This observational study aims to understand the relationship between these heart conditions and sleep issues by assessing sleep patterns before and after these interventions. Participants are divided into two groups based on their treatment: those receiving TAVI for severe aortic stenosis and those receiving M-TEER for severe mitral regurgitation. Both groups undergo full overnight sleep studies called polysomnography before their procedure and again six months later to track changes in breathing patterns during sleep. During the study, participants will have various assessments including sleep studies measuring apnea-hypopnea index and oxygen levels, heart function evaluations using echocardiography, and checks for irregular heart rhythms. Researchers will also collect data on sleep quality, daytime sleepiness, hospitalization, and overall health status over six months to understand how these heart treatments may influence sleep and heart health.
CONDITIONS
Brief 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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants who undergo routine care for transcatheter aortic valve implantation (TAVI) or mitral valve edge-to-edge repair (M-TEER) are observed to assess changes in sleep-disordered breathing and cardiac function.
Visits at baseline, 3 months, and 6 months
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
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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