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

NCT06891079 | Enrolling By Invitation DMC

• 1 other identifier: OVAL GUIDE CHINA
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Aortic stenosis; transcatheter aortic valve implantation; videodensitometry; Paravalvular regurgitation

Outcome Measures

Primary Outcomes (1)

• CMR-derived regurgitation fraction

  The Cardiac magnetic resonance-derived regurgitation fraction at discharge.

  at discharge 1 day, an average of 7days

Secondary Outcomes (18)

• Medical cost

  at discharge 1 day, an average of 7days

• Radiation dose

  during the procedure

• Time in the Cathlab

  during the procedure

• Time for the TAVI procedure

  during the procedure

• All-cause mortality and its sub-categories

  at discharge 1 day, an average of 7days; 30-day; 1 year

Study Arms (2)

Experimental arm

EXPERIMENTAL

TAVI procedure guided by post-implantation aortographic quantitative videodensitometric assessment.

Diagnostic Test: Videodensitometric guided

Control arm

ACTIVE COMPARATOR

TAVI procedure guided by post-implantation standard of care according to local practice.

Diagnostic Test: Stand of care guided

Interventions

Videodensitometric guided DIAGNOSTIC_TEST

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

Experimental arm

Stand of care guided DIAGNOSTIC_TEST

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.

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has aortic stenosis with indication of TAVI implantation as determined by Heart Team.
• Patient is at least 18 years of age.
• Signed informed consent. The patient understands and accepts clinical follow-up.

You may not qualify if:

• Subject is not willing to provide an informed consent form, or whose legal heirs object to their participation in the study.
• If the patient is not suitable for participating in the study, based on the evaluation by the operators.
• Cardiogenic shock.
• Significant comorbidities precluding clinical follow-up (as judged by investigators).
• History of TAVI or SAVR.
• Renal insufficiency (GFR/MDRD \<45 ml/min), which precludes in operator's opinion contrast injection during repeat aortography.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (2)

Zhongshan hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Xijing hospital

Xi'an, Shannxi, 71000, China

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Ling Tao, PhD

  Xijing Hospital, Xi'an, Shannxi, China

  STUDY CHAIR

• Junbo Ge, PhD

  Zhongshan hospital, Fudan University, Shanghai, China

  PRINCIPAL INVESTIGATOR

• Patrick Washington Serruys, PhD

  National University of Ireland Galway, Galway, Ireland

  STUDY CHAIR

• Yoshinobu Onuma, Ph D

  National University of Ireland Galway, Galway, Ireland

  STUDY CHAIR

• Daxin Zhou, PhD

  Zhongshan hospital, Fudan University, Shanghai, China

  STUDY CHAIR

• Rutao Wang, PhD

  Xijing Hospital, Xi'an, Shannxi, China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: March 24, 2025
• Study Start: March 28, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)