Impact of Transcatheter Aortic Valve Implantation and Mitral Valve Repair on Sleep-Disordered Breathing (SLEEP-VALVE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis; Mitral Valve Regurgitation; Sleep-disordered Breathing (SDB)

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Aristides Plaitis, MD, MSc; Phone Number: +306945023017; Email: aris.plaitis@gmail.com

Study Locations

• Greece
  • Attica
    • Athens, Attica, Greece, 11527
      • Recruiting
      • Hippocratio General Hospital of Athens
      • Contact: Aristides Plaitis, MD, MSc; Phone Number: +306945023017; Email: aris.plaitis@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with severe aortic stenosis or severe mitral regurgitation undergoing transcatheter valve interventions (TAVI or M-TEER) at a tertiary care center.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
TAVI Group; Patients undergoing TAVI for severe aortic stenosis.
M-TEER Group; Patients undergoing M-TEER for severe mitral regurgitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in AHI	Assessment of change in AHI from baseline to 6 months after transcatheter valve intervention, as measured by full polysomnography.	Baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in central apnea index (CAI)	Assessment of change in CAI from baseline to 6 months after transcatheter valve intervention, as measured by full polysomnography.	Baseline and 6 months
Change in obstructive apnea index (OAI)	Assessment of change in OAI from baseline to 6 months after transcatheter valve intervention, as measured by full polysomnography.	Baseline and 6 months
Change in oxygen desaturation index (ODI)	Assessment of change in ODI from baseline to 6 months after transcatheter valve intervention, as measured by full polysomnography.	Baseline and 6 months
Change in Epworth Sleepiness Scale (ESS) score	Assessment of change in the ESS score from baseline to 6 months after transcatheter valve intervention. The ESS is a self-administered questionnaire measuring daytime sleepiness, with scores ranging from 0 to 24; higher scores indicate worse daytime sleepiness.	Baseline and 6 months
Change in Pittsburgh Sleep Quality Index (PSQI) score	Assessment of change in the PSQI global score from baseline to 6 months after transcatheter valve intervention. The PSQI is a self-administered questionnaire assessing sleep quality, with scores ranging from 0 to 21; higher scores indicate worse sleep quality.	Baseline and 6 months
Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) index score	Assessment of change in the EQ-5D-5L index score from baseline to 6 months after transcatheter valve intervention. The EQ-5D-5L index score is a standardized measure of health-related quality of life derived from the five EQ-5D dimensions; higher scores indicate better health	Baseline and 6 months
Change in EuroQol Visual Analogue Scale (EQ VAS) score	Assessment of change in the EQ VAS score from baseline to 6 months after transcatheter valve intervention. The EQ VAS records the patient's self-rated health on a scale from 0 to 100, where higher scores indicate better health status.	Baseline and 6 months
Change in left ventricular ejection fraction (LVEF)	Evaluation of change in LVEF, as assessed by transthoracic echocardiography, from baseline to 3 months and 6 months after transcatheter valve intervention.	Baseline, 3 months, and 6 months
Change in systolic pulmonary artery pressure	Evaluation of change in systolic pulmonary artery pressure, as assessed by transthoracic echocardiography, from baseline to 3 months and 6 months after transcatheter valve intervention.	Baseline, 3 months, and 6 months
Occurrence of arrhythmic events	Assessment of arrhythmias using 24-hour Holter monitoring.	Up to 6 months
Number of participants with all-cause hospitalization	Number of participants with at least one hospitalization during follow-up after transcatheter valve intervention.	Up to 6 months
Number of participants with all-cause mortality	Number of participants who die from any cause during follow-up after transcatheter valve intervention.	Up to 6 months

Collaborators and Investigators

• Sponsor: Aristides Plaitis

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2025
• Primary Completion (Estimated): July 20, 2028
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: March 29, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: mitral valve repair; obstructive sleep apnea; osa; mitral regurgitation; MitraClip; aortic stenosis; MR; transcatheter aortic valve implantation; sleep apnea; central sleep apnea; sleep disordered breathing; mitral valve; sdb; aortic valve; AS; valvular heart disease; sleep-disordered breathing; transcatheter; tavi; m-teer; csa
• Additional Relevant MeSH Terms: Aortic Valve Disease; Bone Diseases; Musculoskeletal Diseases; Nervous System Diseases; Cardiovascular Diseases; Heart Diseases; Genetic Diseases, Inborn; Metabolic Diseases; Respiratory Tract Diseases; Respiration Disorders; Neurodegenerative Diseases; Ventricular Outflow Obstruction; Sleep Wake Disorders; Congenital Abnormalities; Abnormalities, Multiple; Heredodegenerative Disorders, Nervous System; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; DNA Repair-Deficiency Disorders; Bone Diseases, Developmental; Dwarfism; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Aortic Valve Stenosis; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Mitral Valve Insufficiency; Heart Valve Diseases; Sleep Apnea, Central; Cockayne Syndrome
• Other Study ID Numbers: SLEEP-VALVE-STUDY-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No