Post-Dilatation Effect on TAVI Prostheses Expansion (DUOTAP)

Medical University of Vienna

Status

Enrolling

Conditions

Aortic Valve Stenosis

Treatments

Other: Post-dilatation

Study type

Interventional

Funder types

Other

Identifiers

NCT07477002

2329/2024

Details and patient eligibility

About

Asymmetrical and inadequate expansion of trans-catheter heart valves (THVs) have been described as a key predictor of impaired valve hemodynamic performance predisposing patients for bio-prosthetic 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 DUO-TAP trial aims to assess efficacy and safety of routine post-dilatation on THV expansion, asymmetry, hemodynamic, durability, and associated clinical outcomes in patients with severe aortic stenosis.

Full 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 DUO-TAP 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; V2 (Pre-discharge): Routine blood and urine analysis (Serum creatinine, NT-proBNP, electrolytes, full blood count, etc.), Echocardiography; V3 (3 months Post-TAVI): Assessment of cross-sectional area of implanted TAVI prostheses on computed tomography (CT); V4 (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; V5 (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 at discharge, Peri-procedural, at 3 months, at 1 year and at 5 years post TAVI.

Enrollment

146 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Severe AS
AS treatment by transfemoral TAVI as determined by an interdisciplinary heart team board
Anatomical feasibility to receive a balloon-expandable TAVI
Age 65 years or older
Subject or guardian agrees to all provisions of the protocol, including the possibility of randomization to the control group and returning for all required post-procedure follow up visits, and has provided written informed consent

Exclusion criteria

Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., non compliant, perforated)
Active infections requiring current antibiotic therapy
Bicuspid aortic valve anatomy
Pregnant or planning pregnancy within next 12 months
Severe calcification of the aortic annulus protruding in the left ventricular outflow tract (predisposing for annular rupture)
Significant coronary artery disease with substantial risk of hemodynamic instability during rapid ventricular pacing