Aortic Valve Stenosis, Mitral Valve Regurgitation, Sleep-disordered Breathing (SDB)
Conditions
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
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.
Interventions
None listed
Sponsors
Aristides Plaitis
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in AHI | Baseline and 6 months | Assessment of change in AHI from baseline to 6 months after transcatheter valve intervention, as measured by full polysomnography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in central apnea index (CAI) | Baseline and 6 months | Assessment of change in CAI from baseline to 6 months after transcatheter valve intervention, as measured by full polysomnography. |
| Change in obstructive apnea index (OAI) | Baseline and 6 months | Assessment of change in OAI from baseline to 6 months after transcatheter valve intervention, as measured by full polysomnography. |
| Change in oxygen desaturation index (ODI) | Baseline and 6 months | Assessment of change in ODI from baseline to 6 months after transcatheter valve intervention, as measured by full polysomnography. |
| Change in Epworth Sleepiness Scale (ESS) score | 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. |
| Change in Pittsburgh Sleep Quality Index (PSQI) score | 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. |
| Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) index score | 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 |
| Change in EuroQol Visual Analogue Scale (EQ VAS) score | 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. |
| Change in left ventricular ejection fraction (LVEF) | 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. |
| Change in systolic pulmonary artery pressure | 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. |
| Occurrence of arrhythmic events | Up to 6 months | Assessment of arrhythmias using 24-hour Holter monitoring. |
| Number of participants with all-cause hospitalization | Up to 6 months | Number of participants with at least one hospitalization during follow-up after transcatheter valve intervention. |
| Number of participants with all-cause mortality | Up to 6 months | Number of participants who die from any cause during follow-up after transcatheter valve intervention. |
Countries
Greece
Contacts
CONTACTAristides Plaitis, MD, MSc
Outcome results
None listed