Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 12:14 AM
Study NCT ID:
NCT07477002
Status:
RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Dilatation Effect on TAVI Prostheses Expansion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 146}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2031-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2026-03-03', 'studyFirstSubmitQcDate': '2026-03-12', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline in NT-proBNP', 'timeFrame': 'At year 1 and year 5 post THV-Implantation'}, {'measure': 'Change from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score', 'timeFrame': 'At year 1 and year 5 post THV-Implantation', 'description': 'Kansas City Cardiomyopathy Questionnaire Overall Score:\n\nMinimum score: 0 Maximum score: 100 Higher scores indicate better cardiovascular health.'}], 'primaryOutcomes': [{'measure': 'TAVI asymmetry index on freeze-frame fluoroscopic images', 'timeFrame': 'Peri-procedural', 'description': 'The TAVI asymmetry will be calculated as: longer THV height/shorter THV height) - 1\\] × 100.\n\nThe TAVI asymmetry index:\n\nMinimum value: 0 Maximum value: NA Higher values indicate more asymmetry.'}], 'secondaryOutcomes': [{'measure': 'Cross-sectional area of implanted THV on CT scans', 'timeFrame': 'At 3 months post THV-Implantation'}, {'measure': 'Major periprocedural complications', 'timeFrame': 'At 2 weeks post THV-Implantation'}, {'measure': 'Mean residual trans-prosthetic gradient', 'timeFrame': 'At year 1 and year 5 post THV-Implantation'}, {'measure': 'Prevalence of bioprosthetic valve degeneration according to the Aortic Valve Academic Research Consortium criteria', 'timeFrame': 'At year 1 and year 5 post THV-Implantation'}, {'measure': 'All-cause mortality', 'timeFrame': 'At year 1 and year 5 post THV-Implantation'}, {'measure': 'Cumulative frequency of CV-related hospitalizations', 'timeFrame': 'At year 1 and year 5 post THV-Implantation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Balloon-expandable TAVI prostheses', 'Fluoroscopic imaging', 'Computed tomography', 'Post-Dilatation', 'Double-Tap'], 'conditions': ['Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'Asymmetrical and inadequate expansion of trans-catheter heart valves (THVs) have been described as a key predictor of impaired valve hemodynamic performance predisposing patients for bio-prosthetic valve dysfunction (BVD) and death. Post-dilatation using the original delivery system balloon at the identical filling volume after deployment of balloon-expandable THVs represents an invasive strategy to potentially optimize expansion and reduce asymmetry of balloon-expandable THVs. Currently, the efficacy and safety of routine post-dilatation has never been assessed in a randomized controlled fashion. The present randomized controlled DUO-TAP trial aims to assess efficacy and safety of routine post-dilatation on THV expansion, asymmetry, hemodynamic, durability, and associated clinical outcomes in patients with severe aortic stenosis.', 'detailedDescription': 'This study is a randomized controlled trial investigating the effect of routine post-dilatation, using the original delivery balloon at nominal volume, in patients scheduled for and receiving a balloon-expandable THV at the Medical University of Vienna. Consecutive adult patients with severe degenerative AS scheduled for a balloon expandable THV will be prospectively enrolled at a university-affiliated tertiary center in Austria. Eligibility and decision for TAVI will be determined by a multidisciplinary Heart Team. All patients who are willing to participate will then be randomly assigned in a 1:1 ratio to undergo a) routine post-dilatation using the original delivery balloon at nominal volumes or b) no post-dilatation after THV deployment.\n\nMethods:\n\nThe DUO-TAP trial is an investigator-driven, prospective, single-blinded, randomized, controlled trial performed at the Medical University of Vienna. In patients assigned to the intervention group post-dilatation will be performed right after deployment of the THV. The balloon will be re-inserted into the deployed THV and after initiation of rapid ventricular pacing the balloon will be inflated at the level of the deployed TAVI prosthesis and then will be immediately deflated again. The duration of rapid ventricular pacing and additional balloon deployment is in the range of a few seconds.\n\nPre-specified study visits:\n\nV0 (Pre-TAVI): Medical history and physical evaluation (concomitant diseases, risk factors, medication, EuroSCORE-II, height, weight, age, sex, blood pressure, heart rate, ECG, symptoms), Routine blood and urine analysis (serum creatinine, NT-proBNP, electrolytes, full blood count, etc.), Echocardiography, KCCQ overall score; V1 (TAVI): Fluoroscopic assessment of THV asymmetry; V2 (Pre-discharge): Routine blood and urine analysis (Serum creatinine, NT-proBNP, electrolytes, full blood count, etc.), Echocardiography; V3 (3 months Post-TAVI): Assessment of cross-sectional area of implanted TAVI prostheses on computed tomography (CT); V4 (1 year Post-TAVI): Medical history and physical evaluation (concomitant diseases, risk factors, medication, EuroSCORE-II, height, weight, age, sex, blood pressure, heart rate, ECG, symptoms), Routine blood and urine analysis (Serum creatinine, NT-proBNP, electrolytes, full blood count, etc.), Echocardiography, KCCQ overall score; V5 (5 years Post-TAVI): Medical history and physical evaluation (concomitant diseases, risk factors, medication, EuroSCORE-II, height, weight, age, sex, blood pressure, heart rate, ECG, symptoms), Routine blood and urine analysis (Serum creatinine, NT-proBNP, electrolytes, full blood count, etc.), Echocardiography, KCCQ overall score\n\nOutcome:\n\nOutcomes (see below) will be assessed at discharge, Peri-procedural, at 3 months, at 1 year and at 5 years post TAVI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe AS\n* AS treatment by transfemoral TAVI as determined by an interdisciplinary heart team board\n* Anatomical feasibility to receive a balloon-expandable TAVI\n* Age 65 years or older\n* Subject or guardian agrees to all provisions of the protocol, including the possibility of randomization to the control group and returning for all required post-procedure follow up visits, and has provided written informed consent\n\nExclusion Criteria:\n\n* Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., non compliant, perforated)\n* Active infections requiring current antibiotic therapy\n* Bicuspid aortic valve anatomy\n* Pregnant or planning pregnancy within next 12 months\n* Severe calcification of the aortic annulus protruding in the left ventricular outflow tract (predisposing for annular rupture)\n* Significant coronary artery disease with substantial risk of hemodynamic instability during rapid ventricular pacing'}, 'identificationModule': {'nctId': 'NCT07477002', 'acronym': 'DUOTAP', 'briefTitle': 'Post-Dilatation Effect on TAVI Prostheses Expansion', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Effects of Post-Dilatation on Valve Hemodynamics, Durability and Outcome in Balloon-Expandable TAVI Prostheses (The Randomized-Controlled DUOTAP Trial).', 'orgStudyIdInfo': {'id': '2329/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No post-dilatation after THV deployment'}, {'type': 'EXPERIMENTAL', 'label': 'Nominal post-dilatation using the original delivery balloon', 'interventionNames': ['Other: Post-dilatation']}], 'interventions': [{'name': 'Post-dilatation', 'type': 'OTHER', 'description': 'Nominal post-dilatation using the original delivery balloon', 'armGroupLabels': ['Nominal post-dilatation using the original delivery balloon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Christian Nitsche, MD, PhD', 'role': 'CONTACT', 'email': 'christian.nitsche@meduniwien.ac.at', 'phone': '+43-1-40400-48590'}, {'name': 'Philipp E Bartko, MD, PhD', 'role': 'CONTACT', 'email': 'philippemanuel.bartko@meduniwien.ac.at', 'phone': '+43-1-40400-48590'}, {'name': 'Christian Nitsche, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Christian Nitsche, MD, PhD', 'role': 'CONTACT', 'email': 'christian.nitsche@meduniwien.ac.at', 'phone': '+43-1-40400-48590'}, {'name': 'Philipp E Bartko, MD, PhD', 'role': 'CONTACT', 'email': 'philippemanuel.bartko@meduniwien.ac.at', 'phone': '+43-1-40400-48590'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Christian Nitsche', 'investigatorAffiliation': 'Medical University of Vienna'}}}}