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

NCT07520656 | Recruiting

• 1 other identifier: SLEEP-VALVE-STUDY-2025
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Sleep-disordered Breathing (SDB); Aortic Valve Stenosis; Mitral Valve Regurgitation

Keywords

tavi; m-teer; sleep apnea; sleep disordered breathing; aortic stenosis; aortic valve; mitral regurgitation; AS; MR; mitral valve; transcatheter; sdb; sleep-disordered breathing; obstructive sleep apnea; osa; central sleep apnea; csa; transcatheter aortic valve implantation; mitral valve repair; MitraClip; valvular heart disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Change in central apnea index (CAI)

  Baseline and 6 months

• Change in obstructive apnea index (OAI)

  Baseline and 6 months

• Change in oxygen desaturation index (ODI)

  Baseline and 6 months

• Change in Epworth Sleepiness Scale (ESS) score

  Baseline and 6 months

• Change in Pittsburgh Sleep Quality Index (PSQI) score

  Baseline and 6 months

Study Arms (2)

TAVI Group

Patients undergoing TAVI for severe aortic stenosis.

M-TEER Group

Patients undergoing M-TEER for severe mitral regurgitation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult patients undergoing TAVI or M-TEER
• Ability to undergo polysomnography
• Provision of written informed consent

You may not qualify if:

• Inability to undergo sleep study (polysomnography)
• Inability to complete follow-up at 6 months
• Cognitive impairment (e.g., dementia)
• Refusal to participate

Sponsors & Collaborators

• Aristides Plaitis: lead

Study Sites (1)

Hippocratio General Hospital of Athens

Athens, Attica, 11527, Greece

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes; Aortic Valve Stenosis; Mitral Valve Insufficiency; Sleep Apnea, Obstructive; Sleep Apnea, Central; Cockayne Syndrome; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Aortic Valve Disease; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Aristides Plaitis, MD, MSc

CONTACT

+306945023017; aris.plaitis@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: April 9, 2026
• Study Start: July 20, 2025
• Primary Completion (Estimated): July 20, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)