Impact of Transcatheter Aortic Valve Implantation and Mitral Valve Repair on Sleep-Disordered Breathing
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAristides Plaitis
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Adult patients undergoing TAVI or M-TEER
Ability to undergo polysomnography
Provision of written informed consent
Disqualifiers
Inability to undergo sleep study (polysomnography)
Inability to complete follow-up at 6 months
Cognitive impairment (e.g., dementia)
Refusal to participate
Trial population
Patients with severe aortic stenosis or severe mitral regurgitation undergoing transcatheter valve interventions (TAVI or M-TEER) at a tertiary care center.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 2 trial groupsGroup A: TAVI Group
Group B: M-TEER Group
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Aristides Plaitis
Lead sponsor
Hippocration General Hospital
Sponsor institution
Source ClinicalTrials.gov