Impact of Transcatheter Aortic Valve Implantation and Mitral Valve Repair on Sleep-Disordered Breathing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Sleep-disordered Breathing (SDB), Aortic Valve Stenosis, Mitral Valve Regurgitation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Transcatheter Aortic Valve Implantation and Transcatheter Mitral Valve Edge-to-Edge Repair on Sleep-Disordered Breathing
Overview
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.
Primary outcome measures
- Change in AHI [Time frame: Baseline and 6 months]
Secondary outcome measures (12)
- Change in central apnea index (CAI) [Time frame: Baseline and 6 months]
- Change in obstructive apnea index (OAI) [Time frame: Baseline and 6 months]
- Change in oxygen desaturation index (ODI) [Time frame: Baseline and 6 months]
- Change in Epworth Sleepiness Scale (ESS) score [Time frame: Baseline and 6 months]
- Change in Pittsburgh Sleep Quality Index (PSQI) score [Time frame: Baseline and 6 months]
- Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) index score [Time frame: Baseline and 6 months]
- Change in EuroQol Visual Analogue Scale (EQ VAS) score [Time frame: Baseline and 6 months]
- Change in left ventricular ejection fraction (LVEF) [Time frame: Baseline, 3 months, and 6 months]
- Change in systolic pulmonary artery pressure [Time frame: Baseline, 3 months, and 6 months]
- Occurrence of arrhythmic events [Time frame: Up to 6 months]
- Number of participants with all-cause hospitalization [Time frame: Up to 6 months]
- Number of participants with all-cause mortality [Time frame: Up to 6 months]
Eligibility criteria
Inclusion criteria
- Adult patients undergoing TAVI or M-TEER
- Ability to undergo polysomnography
- Provision of written informed consent
Exclusion criteria
- Inability to undergo sleep study (polysomnography)
- Inability to complete follow-up at 6 months
- Cognitive impairment (e.g., dementia)
- Refusal to participate
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Greece · 1 center
- Hippocratio General Hospital of Athens — Athens
Identifiers
NCT: NCT07520656 · SLEEP-VALVE-STUDY-2025