[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632974":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":21,"responsibleParty":38,"collaborators":10,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":44,"sex":50,"minAge":51,"maxAge":10,"enrollmentInfo":52,"targetDuration":10,"studyType":55,"phases":10,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":24,"whyStopped":10,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Hippocration General Hospital","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"TAVI Group",null,"Patients undergoing TAVI for severe aortic stenosis.",{"label":13,"type":10,"description":14,"interventionNames":10},"M-TEER Group","Patients undergoing M-TEER for severe mitral regurgitation.",[16],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"Aristides Plaitis, MD, MSc","CONTACT","+306945023017","aris.plaitis@gmail.com",[22],{"facility":23,"status":24,"city":25,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Hippocratio General Hospital of Athens","RECRUITING","Athens","Attica","11527","Greece","GR",{"type":31,"coordinates":32},"Point",[33,34],23.72784,37.98376,{"lat":34,"lon":33},[37],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Aristides Plaitis","Principal Investigator","100632974","impact-of-transcatheter-aortic-valve-implantation-and-mitral-valve-repair-on-sleep-disordered-breathing-100632974",false,"NCT07520656","Impact of Transcatheter Aortic Valve Implantation and Mitral Valve Repair on Sleep-Disordered Breathing","Impact of Transcatheter Aortic Valve Implantation and Transcatheter Mitral Valve Edge-to-Edge Repair on Sleep-Disordered Breathing","SLEEP-VALVE","Inclusion Criteria:\n\n* Adult patients undergoing TAVI or M-TEER\n* Ability to undergo polysomnography\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Inability to undergo sleep study (polysomnography)\n* Inability to complete follow-up at 6 months\n* Cognitive impairment (e.g., dementia)\n* Refusal to participate","ALL","18 Years",{"count":53,"type":54},150,"ESTIMATED","OBSERVATIONAL","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.",[58,59,60],"Sleep-disordered Breathing (SDB)","Aortic Valve Stenosis","Mitral Valve Regurgitation",[62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82],"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","valvular heart disease","2026-04-02",{"date":85,"type":86},"2026-04-09","ACTUAL",{"date":88,"type":86},"2025-07-20",{"date":90,"type":54},"2029-09-01",{"name":40,"class":6},1]