Videodensitometric Angiographic Assessment of AR in the Cath-lab for Intraprocedural Guidance of TAVI in CHINA

Summary

This clinical trial, a prospective, randomized, multicenter study, assigns patients to either videodensitometry-guided TAVI or conventional TTE/TEE-guided TAVI (stand of care), with the primary endpoint being regurgitation fraction measured by cardiac magnetic resonance (CMR) at discharge. Current AR assessment methods, like subjective visual grading or intraprocedural TTE, face limitations in objectivity and practicality, whereas videodensitometry offers real-time, quantitative feedback to guide corrective actions (e.g., post-dilation) during TAVI. If proven non-inferior, this approach could streamline workflows by reducing reliance on general anesthesia and complex imaging, potentially lowering complications and expanding accessibility, particularly in centers lacking advanced echocardiography resources.

Conditions

• Aortic Stenosis

Interventions

DIAGNOSTIC_TEST

Videodensitometric guided

In the experimental arm, a TAVI device is implanted according to the local practice. Immediately after implantation, aortography is performed to quantitatively assess the aortic regurgitation (qAR). The aortography is analyzed using CAAS A-Valve (Pie-Medical, Maastricht, The Netherlands). •If qAR is \>17%, we recommend that corrective post-TAVI manoeuvres (post-dilatation, valve-in-valve, etc.) will be performed and angiography is repeated for the assessment of aortic regurgitation. If the qAR ≤17%, whether corrective post-TAVI manoeuvres (post-dilatation, valve-in-valve, etc.) will be performed is left to the discretion of the operators. Inform operators of the results of qAR and the threshold criteria. Continuous qAR was stratified into categorical variables according to the following pre-determined threshold criteria: (1) none or trace (qAR \<6%); (2) mild (6% to ≤17%); and (3) moderate or severe (\>17%). At discharge, all the patients will undergo Cardiac magnetic resonance, the Car

DIAGNOSTIC_TEST

Stand of care guided

In the control arm, a TAVI device is implanted according to local practice. Immediately after implantation, TEE/TTE or aortography is performed as a part of usual practice. * The requirement of post-dilatation or any additional procedure is left to the discretion of the operator. * The operator judges the sufficient procedural outcome to end the procedure according to local practice. At discharge, all the patients will undergo Cardiac magnetic resonance, the Cardiac magnetic resonance-derived regurgitation fraction (CMR-RF) will be analyzed as the primary endpoint.

Sponsors & Collaborators

• Xijing Hospital

  lead OTHER

Principal Investigators

• Ling Tao, PhD · Xijing Hospital, Xi'an, Shannxi, China

• Junbo Ge, PhD · Zhongshan hospital, Fudan University, Shanghai, China

• Patrick Washington Serruys, PhD · National University of Ireland Galway, Galway, Ireland

• Yoshinobu Onuma, Ph D · National University of Ireland Galway, Galway, Ireland

• Daxin Zhou, PhD · Zhongshan hospital, Fudan University, Shanghai, China

• Rutao Wang, PhD · Xijing Hospital, Xi'an, Shannxi, China

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-28

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• China

Study Locations