Aortic Valve StenosisDUOTAPNCT07477002
Post-Dilatation in Balloon-Expandable TAVI Prostheses
A study testing Post-dilatation in people with Aortic Valve Stenosis, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Post-dilatation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2025to Apr 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Post-Dilatation on THV Expansion, Hemodynamics, Durability, and Outcomes 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.
Read the detailed description
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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Post-dilatation
- Keywords
- Balloon-expandable TAVI prostheses, Fluoroscopic imaging, Computed tomography, Post-Dilatation, Double-Tap
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-dilatationOther
Nominal post-dilatation using the original delivery balloon
| Study group | Role | What they receive |
|---|---|---|
| No post-dilatation after THV deployment | No intervention | Not described |
| Nominal post-dilatation using the original delivery balloon | Experimental | Not described Receives: Other: Post-dilatation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Peri-procedural
Secondary outcomes (9)
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.
Measured: Peri-procedural
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.
Measured: 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.
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.
Measured: Peri-procedural
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.
Measured: One day, one year and five years
Doppler Velocity Index
Doppler Velocity Index assessed on transthoracic echocardiography; Minimum value: 0 Maximum value: 1; Higher values indicate better THV hemodynamics.
Measured: One day, one year and five years
Paravalvular Regurgitation
≥mild paravalvular regurgitation on transthoracic echocardiography
Measured: One day, one year and five years
Cross-sectional THV area
Cross-sectional THV area on cardiac CT scans; Minimum value: 0 Maximum value: NA; Measured in millimeter²; Higher values indicate better THV expansion
Measured: Three months
Hypo-attenuated leaflet thickening
Hypo-attenuated leaflet thickening on computed tomography
Measured: Three months
Major periprocedural complications
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Jan 2025
- Primary completion23 Apr 2026
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Nitsche, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477002
- Sponsor's protocol ID
- 2329/2024
- Acronym
- DUOTAP
- Status last verified
- Jul 2026
- First submitted
- 3 Mar 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Post-Dilatation on THV Expansion, Hemodynamics, Durability, and Outcomes in Balloon-Expandable TAVI Prostheses
- ClinicalTrials.gov ID
- NCT07477002
- Acronym / sponsor ID
- DUOTAP / 2329/2024
- Conditions
- Aortic Valve Stenosis
- Keywords
- Balloon-expandable TAVI prostheses, Fluoroscopic imaging, Computed tomography, Post-Dilatation, Double-Tap
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 23 Apr 2026 (actual)
- Study completion
- Apr 2031 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No post-dilatation after THV deployment | No intervention | – |
| Nominal post-dilatation using the original delivery balloon | Experimental | Other: Post-dilatation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post-dilatationNominal post-dilatation using the original delivery balloon | Other | Nominal post-dilatation using the original delivery balloon |
Primary outcome
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.
9 secondary outcomes
THV diameters at inflow, midframe and outflow and THV heights at the inner and outer curve
Time frame: Peri-procedural
THV asymmetry index from pre- to post-dilatation in the treatment group
Time frame: 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.
Time frame: Peri-procedural
Residual trans-prosthetic gradient
Time frame: One day, one year and five years
Doppler Velocity Index
Time frame: One day, one year and five years
Paravalvular Regurgitation
Time frame: One day, one year and five years
Cross-sectional THV area
Time frame: Three months
Hypo-attenuated leaflet thickening
Time frame: Three months
Major periprocedural complications
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-dilatation in people with Aortic Valve Stenosis, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
THV-asymmetry index (time frame: Peri-procedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.