How TAVI and M‑TEER affect sleep‑disordered breathing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hippocratio General Hospital of Athens
  Athens, Attica, Greece Recruiting

Study contacts

• Study coordinator: Aristides Plaitis, MD, MSc
• Email: aris.plaitis@gmail.com
• Phone: +306945023017

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Transcatheter Aortic Valve Replacement Registry for Outcomes and Quality Monitoring

  This registry collects information from hospitals about patients undergoing TAVR to see how care and outcomes compare to guidelines and nationwide data.

  Recruiting American College of Cardiology · Washington D.C., District of Columbia · NCT07908355

• Sleep problems in PAH patients: how sleep breathing relates to PAH outcomes

  This study tests how sleep-disordered breathing and nocturnal oxygen changes relate to outcomes in adults with pulmonary arterial hypertension.

  Recruiting Chinese Pulmonary Vascular Disease Research Group · Beijing · NCT07852403

• Vericiguat to slow calcific aortic valve narrowing

  This trial tests whether vericiguat can slow the progression of mild-to-moderate calcific aortic valve stenosis compared with placebo.

  Recruiting Phase 2 West China Hospital · Chengdu, Sichuan · NCT07715279

• CHATEAU Registry: Real-world outcomes after TAVR

  This registry collects real-world data from adults who had TAVR between 2021 and 2025 to see how they do over time and how valve performance holds up.

  Recruiting Eunpyeong St. Mary's Hospital · Seoul · NCT07709858

• Impact of TAVR on kidney function in people with aortic valve disease

  This registry tests how trans-catheter aortic valve implantation affects kidney function and the risk of kidney injury in adults with aortic stenosis.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma, RM · NCT07626710

• Early screening for sleep-disordered breathing in kids at the dentist

  This study tests whether a simple kid-friendly questionnaire can flag risk for sleep-disordered breathing in children aged 8–13 when checked during a dental visit.

  Recruiting University of North Carolina, Chapel Hill · Chapel Hill, North Carolina · NCT07581938

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.