NCT07477002 Post-Dilatation in Balloon-Expandable TAVI Prostheses
| NCT ID | NCT07477002 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Vienna |
| Condition | Aortic Valve Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 146 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 146 participants in total. It began in 2025-01-01 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Asymmetrical and inadequate expansion of transcatheter heart valves (THVs) have been described as a key predictor of impaired valve hemodynamic performance predisposing patients for bioprosthetic 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 DUOTAP trial aims to assess efficacy and safety of routine post-dilatation on THV expansion, hemodynamics, durability, and associated clinical outcomes in patients with severe aortic stenosis.
Eligibility Criteria
Inclusion Criteria: * Severe AS * AS treatment by transfemoral TAVI as determined by an interdisciplinary heart team board * Anatomical feasibility to receive a balloon-expandable THV * Age 65 years or older * Informed consent Exclusion Criteria: * Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., non compliant, perforated) * Bicuspid aortic valve anatomy * Valve-in-valve procedure * Severe calcification of the aortic annulus protruding into the left ventricular outflow tract and predisposing for annular rupture * Significant stenosis of the left main or proximal left anterior descending artery with substantial risk of hemodynamic instability during rapid ventricular pacing
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07477002 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Aortic Valve Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07477002 currently recruiting?
Yes, NCT07477002 is actively recruiting participants. Contact the research team at christian.nitsche@meduniwien.ac.at for enrollment information.
Where is the NCT07477002 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT07477002 clinical trial?
NCT07477002 is sponsored by Medical University of Vienna. The trial plans to enroll 146 participants.