[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659890":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":16,"studyPopulation":16,"armGroups":23,"interventions":32,"overallOfficials":16,"centralContacts":37,"locations":43,"responsibleParty":92,"collaborators":96,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":16,"enrollmentInfo":109,"targetDuration":16,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":121,"overallStatus":126,"whyStopped":16,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"Hypoattenuated Leaflet Thickening (HALT)","HALT (at least one thickened TAV leaflet involving \\> 25% of the leaflet curvilinear dimension as assessed at cardiac CT)","30 days",{"measure":14,"description":15,"timeFrame":12},"Co-primary (safety) endpoint","Composite of 1) freedom from all-cause mortality; 2) freedom from all new stroke; 3) freedom from VARC type 2 to 4 bleeding; 4) freedom from major vascular, access-related, or cardiac structural complications; 5) freedom from acute kidney injury stage 3 or 4; 6) freedom from moderate or severe aortic regurgitation; 7) freedom from new permanent pacemaker implantation caused by procedure related conduction abnormalities; and 8) freedom from surgery or intervention related to the device in accordance with the third Valve Academic Research Consortium (VARC-3) criteria at 30 days.",null,{"allocation":18,"interventionModel":19,"interventionModelDescription":16,"primaryPurpose":20,"observationalModel":16,"timePerspective":16,"maskingInfo":21},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":22,"maskingDescription":16,"whoMasked":16},"NONE",[24,29],{"label":25,"type":26,"description":16,"interventionNames":27},"Double-TAP post-dilatation","ACTIVE_COMPARATOR",[28],"Procedure: Double-TAP post-dilatation",{"label":30,"type":31,"description":16,"interventionNames":16},"No post-dilatation","NO_INTERVENTION",[33],{"type":34,"name":25,"description":35,"armGroupLabels":36,"otherNames":16},"PROCEDURE","If patient is randomized to treatment arm the TAVI delivery balloon is aligned at valve level and reinflated to nominal volume for 3 seconds under rapid pacing.",[25],[38],{"name":39,"role":40,"phone":41,"phoneExt":16,"email":42},"Rutger-Jan M Nuis, MD PhD","CONTACT","0031(0)107035260","r.nuis@erasmusmc.nl",[44,60,68,81],{"facility":45,"status":16,"city":46,"state":16,"zip":16,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Amsterdam University Medical Center","Amsterdam","Netherlands","NL",{"type":50,"coordinates":51},"Point",[52,53],4.88969,52.37403,{"lat":53,"lon":52},[56],{"name":57,"role":40,"phone":58,"phoneExt":16,"email":59},"Ronak Delewi, MD PhD","+31205669111","r.delewi@amsterdamumc.nl",{"facility":61,"status":16,"city":62,"state":16,"zip":16,"country":47,"countryCode":48,"cosmosGeoPoint":63,"geoPoint":67,"contacts":16},"Amphia Hospital","Breda",{"type":50,"coordinates":64},[65,66],4.77596,51.58656,{"lat":66,"lon":65},{"facility":69,"status":16,"city":70,"state":16,"zip":16,"country":47,"countryCode":48,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Maastricht University Medical Center","Maastricht",{"type":50,"coordinates":72},[73,74],5.68889,50.84833,{"lat":74,"lon":73},[77],{"name":78,"role":40,"phone":79,"phoneExt":16,"email":80},"Pieter Vriesendorp, MD PhD","+31433876543","pieter.vriesendorp@mumc.nl",{"facility":82,"status":16,"city":83,"state":16,"zip":16,"country":47,"countryCode":48,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Erasmus Medical Center Rotterdam","Rotterdam",{"type":50,"coordinates":85},[86,87],4.47917,51.9225,{"lat":87,"lon":86},[90],{"name":39,"role":40,"phone":91,"phoneExt":16,"email":42},"+31614858291",{"type":93,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"PRINCIPAL_INVESTIGATOR","Rutger-Jan Nuis","MD PhD",[97],{"name":98,"class":99},"Edwards Lifesciences","INDUSTRY","100659890","symmetric-valve-frame-expansion-to-reduce-hypoattenuated-leaflet-thickening-after-balloon-expandable-tavi-the-symmetry-trial-100659890",false,"NCT07872020","SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial","SYMMETRY","Inclusion Criteria:\n\n* Age ≥ 70 years\n* Patients with severe aortic stenosis undergoing TAVI with a balloon-expandable valve\n* Written informed consent\n\nExclusion Criteria:\n\n* Significant valve frame under-expansion and\u002For ≥ moderate paravalvular leakage warranting post-dilatation at the discretion of the treating physician\n* Shallow implantation depth with increased risk of valve embolization upon post-dilatation\n* Sievers type 1 bicuspid aortic valve with calcified raphe\n* Indication for oral anticoagulant therapy\n* Estimated glomerular filtration rate \\\u003C30 ml\u002Fmin\n* Iodine contrast allergy","ALL","70 Years",{"count":110,"type":111},422,"ESTIMATED","INTERVENTIONAL",[114],"NA","Rationale: Transcatheter aortic valve implantation (TAVI) has become the standard of care for aortic stenosis across all surgical risk categories, including low-risk, younger patients (≥70 years). As many of these patients are expected to outlive their prosthetic valves, the durability of the valve becomes an increasingly critical factor. Hypoattenuated leaflet thickening (HALT), a finding on post-TAVI computed tomography (CT), occurs in approximately 20% of patients and is associated with bioprosthetic valve dysfunction. Balloon-expandable valves seem more susceptible to HALT with an occurrence rate of 21%, compared to 16% for self-expanding valves.\n\nA recent study identified underexpansion of the transcatheter heart valve prosthesis as a key predictor of HALT at 30 days, which in turn was associated with a sixfold increase in cardiovascular mortality and a threefold increase in all-cause mortality at 1 year. Moreover, data suggest that, in the absence of post-dilatation, more than 95% of balloon-expandable valve implants exhibit some degree of underexpansion. In contrast, routine post-dilatation enhances valve expansion and hemodynamic performance without significantly increasing adverse events. The double-TAP technique-re-inflation of the TAVI delivery balloon after initial valve deployment-achieves a 9-10% increase in valve frame expansion, potentially reducing HALT risk and improving long-term outcomes.\n\nObjective: To determine whether routine double-TAP post-dilatation after balloon-expandable TAVI is safe and can reduce the incidence of HALT.\n\nStudy design: Investigator-initiated, multicenter, open-label, randomized trial with 1:1 allocation to routine post-dilatation using double-TAP versus no post-dilatation immediately after balloon expandable valve deployment.\n\nStudy population: 422 Patients undergoing balloon-expandable TAVI for native aortic valve stenosis Investigational intervention: TAVI with a balloon-expandable valve followed by double-TAP post-dilatation.\n\nStudy design: Investigator-initiated, multicenter, open-label, randomized trial with 1:1 allocation to routine post-dilatation using double-TAP versus no post-dilatation immediately after balloon expandable valve deployment.\n\nStudy population: 422 Patients undergoing balloon-expandable TAVI for native aortic valve stenosis\n\nInvestigational intervention: TAVI with a balloon-expandable valve followed by double-TAP post-dilatation.",[117,118,119,120],"Aortic Valve Stenosis and\u002For Insufficiency","Hypoattenuated Leaflet Thickening","Valve Expansion","Transcatheter Aortic Valve Replacement",[122,123,124,125],"Aortic valve stenosis","Aortic valve regurgitation","Post-dilatation","Balloon-expandable valves","NOT_YET_RECRUITING","2026-10-07",{"date":129,"type":130},"2026-10-13","ACTUAL",{"date":132,"type":111},"2026-11-01",{"date":134,"type":111},"2033-11-01",{"name":5,"class":6},4]