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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No post-dilatation after THV deployment | No Intervention | ||
| Nominal post-dilatation using the original delivery balloon | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Post-dilatation | Other | Nominal post-dilatation using the original delivery balloon |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in NT-proBNP | One year and five years | |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | State of Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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. | 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. | 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. | 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. | One day, one year and five years |
| Paravalvular Regurgitation | ≥mild paravalvular regurgitation on transthoracic echocardiography | 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 | Three months |
| Hypo-attenuated leaflet thickening | Hypo-attenuated leaflet thickening on computed tomography | Three months |
| Major periprocedural complications | Assessment of:
All defined according to the Valve Academic Research Consortium 3 criteria | 30 days |
| One year and five years |
| Composite of aortic valve re-intervention, cardiovascular hospitalization and all-cause mortality | Time-to-first-event of either aortic valve re-intervention, unplanned cardiovascular hospitalization and all-cause mortality | One year and five years |
| Aortic valve re-intervention | Time to first aortic valve reintervention | One year and five years |
| Cardiovascular hospitalization | Time to first unplanned cardiovascular hospitalization | One year and five years |
| All-cause mortality | Time to all-cause mortality | One year and five years |
| Bioprosthetic valve dysfunction | 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. | One year and five years |
| D014694 |
| Ventricular Outflow Obstruction |