Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAVI Group | Patients undergoing TAVI for severe aortic stenosis. | ||
| M-TEER Group | Patients undergoing M-TEER for severe mitral regurgitation. |
Not provided
| 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 |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with severe aortic stenosis or severe mitral regurgitation undergoing transcatheter valve interventions (TAVI or M-TEER) at a tertiary care center.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aristides Plaitis, MD, MSc | Contact | +306945023017 | aris.plaitis@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hippocratio General Hospital of Athens | Recruiting | Athens | Attica | 11527 | Greece |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001024 | Aortic Valve Stenosis |
| D008944 | Mitral Valve Insufficiency |
| D020181 | Sleep Apnea, Obstructive |
| D020182 | Sleep Apnea, Central |
| D003057 | Cockayne Syndrome |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D000082862 | Aortic Valve Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D049914 | DNA Repair-Deficiency Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |