An observational study in Sleep-disordered Breathing (SDB), Aortic Valve Stenosis and Mitral Valve Regurgitation, sponsored by Aristides Plaitis. Recruiting at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by Aristides Plaitis · Observational
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.
1,084 studies on the registry are indexed under Sleep Apnea Syndromes; 171 are open to participants now.
This study's planned enrollment of 150 is close to the median of 150 across 343 observational studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →This is the only study on the registry with Aristides Plaitis as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients with severe aortic stenosis or severe mitral regurgitation undergoing transcatheter valve interventions (TAVI or M-TEER) at a tertiary care center.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing TAVI for severe aortic stenosis.
Patients undergoing M-TEER for severe mitral regurgitation.
Change in AHI
Assessment of change in AHI from baseline to 6 months after transcatheter valve intervention, as measured by full polysomnography.
Time frame: Baseline and 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 3 months, and 6 months
Occurrence of arrhythmic events
Assessment of arrhythmias using 24-hour Holter monitoring.
Time frame: 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.
Time frame: 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.
Time frame: Up to 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Jul 2028, 36 months after the start.
Of 130 non-industry observational studies under Sleep Apnea Syndromes, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 83. This study's planned 36 months is below that.
Counting every sponsor, half of 149 studies reached it within 43 months; a quarter within 15 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
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