Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07520656

Impact of Transcatheter Aortic Valve Implantation and Mitral Valve 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Sleep-disordered Breathing (SDB) Abnormalities, Multiple Aortic Valve Disease Aortic Valve Stenosis Apnea Bone Diseases Bone Diseases, Developmental Cardiovascular Diseases Cockayne Syndrome Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Repair-Deficiency Disorders Dwarfism Dyssomnias Genetic Diseases, Inborn Heart Diseases Heart Valve Diseases Heredodegenerative Disorders, Nervous System Metabolic Diseases Mitral Valve Insufficiency Mitral Valve Regurgitation Musculoskeletal Diseases Nervous System Diseases Neurodegenerative Diseases Nutritional and Metabolic Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Central Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hippocratio General Hospital of Athens

Athens, Attica, 11527, Greece

Location status: Recruiting

Location contact

Aristides Plaitis, MD, MSc

CONTACT

[email protected]

+306945023017

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in AHI

    Time frame: Baseline and 6 months

    Assessment of change in AHI from baseline to 6 months after transcatheter valve intervention, as measured by full polysomnography.

Secondary outcomes

  1. Change in central apnea index (CAI)

    Time frame: Baseline and 6 months

    Assessment of change in CAI from baseline to 6 months after transcatheter valve intervention, as measured by full polysomnography.

  2. Change in obstructive apnea index (OAI)

    Time frame: Baseline and 6 months

    Assessment of change in OAI from baseline to 6 months after transcatheter valve intervention, as measured by full polysomnography.

  3. Change in oxygen desaturation index (ODI)

    Time frame: Baseline and 6 months

    Assessment of change in ODI from baseline to 6 months after transcatheter valve intervention, as measured by full polysomnography.

  4. Change in Epworth Sleepiness Scale (ESS) score

    Time frame: Baseline and 6 months

    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.

  5. Change in Pittsburgh Sleep Quality Index (PSQI) score

    Time frame: Baseline and 6 months

    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.

  6. Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) index score

    Time frame: Baseline and 6 months

    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

  7. Change in EuroQol Visual Analogue Scale (EQ VAS) score

    Time frame: Baseline and 6 months

    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.

  8. Change in left ventricular ejection fraction (LVEF)

    Time frame: Baseline, 3 months, and 6 months

    Evaluation of change in LVEF, as assessed by transthoracic echocardiography, from baseline to 3 months and 6 months after transcatheter valve intervention.

  9. Change in systolic pulmonary artery pressure

    Time frame: Baseline, 3 months, and 6 months

    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.

  10. Occurrence of arrhythmic events

    Time frame: Up to 6 months

    Assessment of arrhythmias using 24-hour Holter monitoring.

  11. Number of participants with all-cause hospitalization

    Time frame: Up to 6 months

    Number of participants with at least one hospitalization during follow-up after transcatheter valve intervention.

  12. Number of participants with all-cause mortality

    Time frame: Up to 6 months

    Number of participants who die from any cause during follow-up after transcatheter valve intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Aristides Plaitis, MD, MSc

CONTACT

[email protected]

+306945023017

Sponsors and collaborators

Lead sponsor

Aristides Plaitis

Other

Registry information

Official study title

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

Acronym: SLEEP-VALVE

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.