NCT07477002

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
60mo left

Started Jan 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
Jan 2025May 2031

Study Start

First participant enrolled

January 1, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2031

Expected
Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

1.3 years

First QC Date

March 3, 2026

Last Update Submit

May 7, 2026

Conditions

Aortic Valve Stenosis

Keywords

Balloon-expandable TAVI prosthesesFluoroscopic imagingComputed tomographyPost-DilatationDouble-Tap

Outcome Measures

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.

    Peri-procedural

Secondary Outcomes (13)

  • THV diameters at inflow, midframe and outflow and THV heights at the inner and outer curve

    Peri-procedural

  • THV asymmetry index from pre- to post-dilatation in the treatment group

    Peri-procedural

  • 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.

    Peri-procedural

  • Residual trans-prosthetic gradient

    One day, one year and five years

  • Doppler Velocity Index

    One day, one year and five years

  • +8 more secondary outcomes

Other Outcomes (2)

  • Change from baseline in NT-proBNP

    One year and five years

  • Change from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score

    One year and five years

Study Arms (2)

No post-dilatation after THV deployment

NO INTERVENTION

Nominal post-dilatation using the original delivery balloon

EXPERIMENTAL
Other: Post-dilatation

Interventions

Post-dilatationOTHER

Nominal post-dilatation using the original delivery balloon

Nominal post-dilatation using the original delivery balloon

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Central Study Contacts

Christian Nitsche, MD, PhD

CONTACT

+43-1-40400-48590christian.nitsche@meduniwien.ac.at

Philipp E Bartko, MD, PhD

CONTACT

+43-1-40400-48590philippemanuel.bartko@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 17, 2026

Study Start

January 1, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

May 1, 2031

Last Updated

May 12, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)