How TAVI and M‑TEER affect sleep‑disordered breathing
Impact of Transcatheter Aortic Valve Implantation and Transcatheter Mitral Valve Edge-to-Edge Repair on Sleep-Disordered Breathing
Hippocration General Hospital · NCT07520656
This will see if adults with aortic stenosis or mitral regurgitation who undergo TAVI or M‑TEER have improvements in sleep‑disordered breathing six months after their procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hippocration General Hospital (other) |
| Locations | 1 site (Athens, Attica) |
| Trial ID | NCT07520656 on ClinicalTrials.gov |
What this trial studies
This prospective observational study enrolls adults undergoing transcatheter aortic valve implantation (TAVI) or transcatheter mitral valve edge‑to‑edge repair (M‑TEER) at Hippocratio General Hospital in Athens. Participants complete full in‑lab polysomnography before the procedure and again at six months to measure apnea–hypopnea index, central and obstructive apnea indices, oxygen desaturation, and sleep architecture. The study will correlate changes in sleep parameters with echocardiographic measurements and arrhythmic findings collected around the time of the intervention. No experimental treatments are assigned; researchers observe whether routine transcatheter valve procedures are associated with changes in sleep‑disordered breathing.
Who should consider this trial
Good fit: Adults scheduled for TAVI or M‑TEER who can undergo polysomnography and commit to a six‑month follow‑up visit are ideal candidates.
Not a fit: Patients who cannot complete polysomnography, cannot attend six‑month follow‑up, have significant cognitive impairment, or whose sleep apnea is unrelated to cardiac hemodynamics may not benefit from the findings.
Why it matters
Potential benefit: If successful, the findings could show that transcatheter valve procedures improve sleep‑disordered breathing and related symptoms, guiding more integrated cardiac and sleep care.
How similar studies have performed: Small observational reports have suggested that correcting cardiac hemodynamics can improve central sleep apnea, but data specifically on TAVI and M‑TEER are limited and mainly exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Athens, Attica
- Hippocratio General Hospital of Athens — Athens, Attica, Greece (RECRUITING)
Study contacts
- Study coordinator: Aristides Plaitis, MD, MSc
- Email: aris.plaitis@gmail.com
- Phone: +306945023017
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sleep-disordered Breathing, Aortic Valve Stenosis, Mitral Valve Regurgitation, tavi, m-teer, sleep apnea, sleep disordered breathing, aortic stenosis