Post-Dilatation in Balloon-Expandable TAVI Prostheses
ConditionAortic Valve Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorMedical University of Vienna
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Post-dilatation
Other interventionNominal post-dilatation using the original delivery balloon
Treatment groups
146 Participants
are divided into 2 treatment groupsGroup A: No post-dilatation after THV deploymentNo intervention 0 interventions
Group B: Nominal post-dilatation using the original delivery balloonExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
THV-asymmetry index
The THV-asymmetry index will be calculated from freeze-frame fluoroscopic images as: \[(longer THV height/shorter THV height) - 1\] × 100. Minimum value: 0 Maximum value: NA Higher values indicate more asymmetry.
Time frame
Peri-proceduralSecondary outcomes
1
THV diameters at inflow, midframe and outflow and THV heights at the inner and outer curve
THV diameters will be measured on freeze-frame fluoroscopic images. Minimum value: 0 Maximum value: NA Measured in millimeter. Higher values indicate better THV expansion. THV heights will be measured on freeze-frame fluoroscopic images. Minimum value: 0 Maximum value: NA Measured in millimeter. Lower values indicate better THV expansion.
Time frame
Peri-procedural2
THV asymmetry index from pre- to post-dilatation in the treatment group
The THV-asymmetry index will be calculated from freeze-frame fluoroscopic images as: \[(longer THV height/shorter THV height) - 1\] × 100; Minimum value: 0 Maximum value: NA; Higher values indicate more asymmetry.
Time frame
Peri-procedural3
THV diameters at inflow, midframe and outflow and THV heights at the inner and outer curve from pre- to post-dilatation in the treatment group.
THV diameters will be measured on freeze-frame fluoroscopic images. Minimum value: 0 Maximum value: NA Measured in millimeter. Higher values indicate better THV expansion. THV heights will be measured on freeze-frame fluoroscopic images. Minimum value: 0 Maximum value: NA Measured in millimeter. Lower values indicate better THV expansion.
Time frame
Peri-procedural4
Residual trans-prosthetic gradient
Residual trans-prosthetic gradient on transthoracic echocardiography; Minimum value: 0 Maximum value: NA; Measured in mmHg; Lower values indicate better THV hemodynamics.
Time frame
One day, one year and five yearsOther outcomes
1
Change from baseline in NT-proBNP
Time frame
One year and five years2
Change from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score
Kansas City Cardiomyopathy Questionnaire Overall Score: Minimum score: 0 Maximum score: 100 Higher scores indicate better cardiovascular health.
Time frame
One year and five yearsSponsors and contacts
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Source ClinicalTrials.gov