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NCT Number: NCT07477002

Post-Dilatation in Balloon-Expandable TAVI Prostheses

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

About this study

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.

Methods:

The DUOTAP 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.

Pre-specified study visits:

V0 (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, diameters and heights; V2 (Pre-discharge): Routine blood and urine analysis, Echocardiography; V3 (1 month Post-TAVI): Assessment of safety endpoints via phone follow-up; V4 (3 months Post-TAVI): Assessment of cross-sectional THV area on computed tomography (CT); V5 (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; V6 (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

Outcome:

Outcomes (see below) will be assessed peri-procedural, at 1 month, at 3 months, at 1 year and at 5 years post TAVI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Post-dilatation

Other

Nominal post-dilatation using the original delivery balloon

Primary outcomes

  1. THV-asymmetry index

    Time frame: Peri-procedural

    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.

Secondary outcomes

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

    Time frame: Peri-procedural

    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.

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

    Time frame: Peri-procedural

    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.

  3. 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.

    Time frame: Peri-procedural

    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.

  4. Residual trans-prosthetic gradient

    Time frame: One day, one year and five years

    Residual trans-prosthetic gradient on transthoracic echocardiography; Minimum value: 0 Maximum value: NA; Measured in mmHg; Lower values indicate better THV hemodynamics.

  5. Doppler Velocity Index

    Time frame: One day, one year and five years

    Doppler Velocity Index assessed on transthoracic echocardiography; Minimum value: 0 Maximum value: 1; Higher values indicate better THV hemodynamics.

  6. Paravalvular Regurgitation

    Time frame: One day, one year and five years

    ≥mild paravalvular regurgitation on transthoracic echocardiography

  7. Cross-sectional THV area

    Time frame: Three months

    Cross-sectional THV area on cardiac CT scans; Minimum value: 0 Maximum value: NA; Measured in millimeter²; Higher values indicate better THV expansion

  8. Hypo-attenuated leaflet thickening

    Time frame: Three months

    Hypo-attenuated leaflet thickening on computed tomography

  9. Major periprocedural complications

    Time frame: 30 days

    Assessment of:

    • periprocedural death;
    • any type of stroke;
    • procedure- or valve related hospitalization;
    • type ≥2 bleeding;
    • major vascular complication;
    • new conduction system disorders requiring pacemaker implantation;
    • major cardiac structural complication;
    • other acute procedural and technical valve related complications (conversion to open surgery, unplanned use of mechanical circulatory support, implantation of multiple THV valves during the index hospitalization, valve malposition).

    All defined according to the Valve Academic Research Consortium 3 criteria

Other outcomes

  1. Change from baseline in NT-proBNP

    Time frame: One year and five years

  2. Change from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score

    Time frame: One year and five years

    Kansas City Cardiomyopathy Questionnaire Overall Score:

    Minimum score: 0 Maximum score: 100 Higher scores indicate better cardiovascular health.

  3. Composite of aortic valve re-intervention, cardiovascular hospitalization and all-cause mortality

    Time frame: One year and five years

    Time-to-first-event of either aortic valve re-intervention, unplanned cardiovascular hospitalization and all-cause mortality

  4. Aortic valve re-intervention

    Time frame: One year and five years

    Time to first aortic valve reintervention

  5. Cardiovascular hospitalization

    Time frame: One year and five years

    Time to first unplanned cardiovascular hospitalization

  6. All-cause mortality

    Time frame: One year and five years

    Time to all-cause mortality

  7. Bioprosthetic valve dysfunction

    Time frame: One year and five years

    Bioprosthetic valve dysfunction including assessment of structural and non structural valve deterioration (i.e., leaflet thrombosis, endocarditis) on transthoracic echocardiography.

    Bioprosthetic valve dysfunction will be defined according to the Valve Academic Research Consortium 3 criteria.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Effects of Post-Dilatation on THV Expansion, Hemodynamics, Durability, and Outcomes in Balloon-Expandable TAVI Prostheses

Acronym: DUOTAP

Important dates

Study start
2025
Primary completion
2026
Study completion
2031
First posted
Mar 17, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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