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

Recruitingn/aAges 18 Years - anyAllAristides Plaitis
NCT07520656 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 outco

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

1 site
Hippocratio General Hospital of Athens
Athens, Greece
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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