Actively Recruiting
Post-Dilatation in Balloon-Expandable TAVI Prostheses
Led by Medical University of Vienna · Updated on 2026-05-12
146
Participants Needed
1
Research Sites
330 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post-Dilatation in Balloon-Expandable TAVI Prostheses
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Severe aortic stenosis
- Treatment planned by transfemoral TAVI as decided by a heart team
- Anatomical suitability for balloon-expandable transcatheter heart valve
- Age 65 years or older
- Provided informed consent
You will not qualify if you...
- Active endocarditis or active rheumatic heart disease affecting valve leaflets
- Bicuspid aortic valve anatomy
- Valve-in-valve procedure
- Severe calcification of the aortic annulus risking annular rupture
- Significant narrowing of left main or proximal left anterior descending artery causing risk during rapid ventricular pacing
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Medical University of Vienna
Vienna, State of Vienna, Austria, 1090
Actively Recruiting
Research Team
C
Christian Nitsche, MD, PhD
CONTACT
P
Philipp E Bartko, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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