Transcatheter Aortic Valve Replacement (TAVR) Clinical Trials

Clinical trials related to Transcatheter Aortic Valve Replacement (TAVR) Procedure

Impact of Transcatheter Aortic Valve Implantation and Transcatheter Mitral Valve Edge-to-Edge Repair on Sleep-Disordered Breathing

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patients undergoing TAVI or M-TEER

• Ability to undergo polysomnography

• Provision of written informed consent

Locations
Other Locations
Greece
Hippocratio General Hospital of Athens
RECRUITING
Athens
Contact Information
Primary
Aristides Plaitis, MD, MSc
aris.plaitis@gmail.com
+306945023017
Time Frame
Start Date: 2025-07-20
Estimated Completion Date: 2029-09-01
Participants
Target number of participants: 150
Treatments
TAVI Group
Patients undergoing TAVI for severe aortic stenosis.
M-TEER Group
Patients undergoing M-TEER for severe mitral regurgitation.
Sponsors
Leads: Aristides Plaitis

This content was sourced from clinicaltrials.gov