Sleep-disordered Breathing (SDB)SLEEP-VALVENCT07520656
Impact of Transcatheter Aortic Valve Implantation and Mitral Valve Repair on Sleep-Disordered Breathing
An observational study of Sleep-disordered Breathing (SDB) and Aortic Valve Stenosis, run by Aristides Plaitis at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep-disordered Breathing (SDB), Aortic Valve Stenosis, Mitral Valve Regurgitation
- How many people
- 150 participants
- Where
- 1 siteGreece
- Study dates
- 20 Jul 2025to 1 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe aortic stenosis or severe mitral regurgitation undergoing transcatheter valve interventions (TAVI or M-TEER) at a tertiary care center.
Who may be able to join
- Adult patients undergoing TAVI or M-TEER
- Ability to undergo polysomnography
- Provision of written informed consent
Who cannot join
- Inability to undergo sleep study (polysomnography)
- Inability to complete follow-up at 6 months
- Cognitive impairment (e.g., dementia)
- Refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Hippocratio General Hospital of Athens
Athens, Attica, 11527
Aristides Plaitis, MD, MSc, +306945023017, aris.plaitis@gmail.com
About this study
Official title: Impact of Transcatheter Aortic Valve Implantation and Transcatheter Mitral Valve Edge-to-Edge Repair on Sleep-Disordered Breathing
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.
- Keywords
- tavi, m-teer, sleep apnea, sleep disordered breathing, aortic stenosis, aortic valve, mitral regurgitation, AS, MR, mitral valve, transcatheter, sdb, sleep-disordered breathing, obstructive sleep apnea, osa, central sleep apnea, csa, transcatheter aortic valve implantation, mitral valve repair, MitraClip
- Medical subject headings
- Sleep Apnea Syndromes, Aortic Valve Stenosis, Mitral Valve Insufficiency, Sleep Apnea, Obstructive, Sleep Apnea, Central, Cockayne Syndrome, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TAVI Group | Patients undergoing TAVI for severe aortic stenosis. | |
| M-TEER Group | Patients undergoing M-TEER for severe mitral regurgitation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in AHI
Assessment of change in AHI from baseline to 6 months after transcatheter valve intervention, as measured by full polysomnography.
Measured: Baseline and 6 months
Secondary outcomes (12)
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.
Measured: Baseline and 6 months
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months, and 6 months
Occurrence of arrhythmic events
Assessment of arrhythmias using 24-hour Holter monitoring.
Measured: 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.
Measured: 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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start20 Jul 2025
- Primary completion20 Jul 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep-disordered Breathing (SDB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristides Plaitis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aristides Plaitis, Hippocration General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520656
- Sponsor's protocol ID
- SLEEP-VALVE-STUDY-2025
- Acronym
- SLEEP-VALVE
- Status last verified
- Apr 2026
- First submitted
- 29 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Transcatheter Aortic Valve Implantation and Transcatheter Mitral Valve Edge-to-Edge Repair on Sleep-Disordered Breathing
- ClinicalTrials.gov ID
- NCT07520656
- Acronym / sponsor ID
- SLEEP-VALVE / SLEEP-VALVE-STUDY-2025
- Keywords
- tavi, m-teer, sleep apnea, sleep disordered breathing, aortic stenosis, aortic valve, mitral regurgitation, AS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Aristides PlaitisUniversity, hospital or other
- Study start
- 20 Jul 2025 (actual)
- Primary completion
- 20 Jul 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAVI Group | – | –Patients undergoing TAVI for severe aortic stenosis. |
| M-TEER Group | – | –Patients undergoing M-TEER for severe mitral regurgitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe aortic stenosis or severe mitral regurgitation undergoing transcatheter valve interventions (TAVI or M-TEER) at a tertiary care center.
Key inclusion criteria (3 listed)
- Adult patients undergoing TAVI or M-TEER
- Ability to undergo polysomnography
- Provision of written informed consent
Key exclusion criteria (4 listed)
- Inability to undergo sleep study (polysomnography)
- Inability to complete follow-up at 6 months
- Cognitive impairment (e.g., dementia)
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in AHI
Time frame: Baseline and 6 months
Assessment of change in AHI from baseline to 6 months after transcatheter valve intervention, as measured by full polysomnography.
12 secondary outcomes
Change in central apnea index (CAI)
Time frame: Baseline and 6 months
Change in obstructive apnea index (OAI)
Time frame: Baseline and 6 months
Change in oxygen desaturation index (ODI)
Time frame: Baseline and 6 months
Change in Epworth Sleepiness Scale (ESS) score
Time frame: Baseline and 6 months
Change in Pittsburgh Sleep Quality Index (PSQI) score
Time frame: Baseline and 6 months
Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) index score
Time frame: Baseline and 6 months
Change in EuroQol Visual Analogue Scale (EQ VAS) score
Time frame: Baseline and 6 months
Change in left ventricular ejection fraction (LVEF)
Time frame: Baseline, 3 months, and 6 months
Change in systolic pulmonary artery pressure
Time frame: Baseline, 3 months, and 6 months
Occurrence of arrhythmic events
Time frame: Up to 6 months
Number of participants with all-cause hospitalization
Time frame: Up to 6 months
Number of participants with all-cause mortality
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep-disordered Breathing (SDB) and Aortic Valve Stenosis, run by Aristides Plaitis at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aristides Plaitis, MD, MSc (+306945023017, aris.plaitis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in AHI (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.