[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypoattenuated-leaflet-thickening\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypoattenuated-leaflet-thickening":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"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":19,"type":20},422,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29],"Aortic Valve Stenosis and\u002For Insufficiency","Hypoattenuated Leaflet Thickening","Valve Expansion","Transcatheter Aortic Valve Replacement",[31,32,33,34],"Aortic valve stenosis","Aortic valve regurgitation","Post-dilatation","Balloon-expandable valves","NOT_YET_RECRUITING","2026-10-07",{"date":38,"type":39},"2026-10-13","ACTUAL",{"date":41,"type":20},"2026-11-01",{"date":43,"type":20},"2033-11-01",{"name":45,"class":46},"Erasmus Medical Center","OTHER",4]