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

NCT ID: NCT06891079

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-28
• Study Completion Date: 2026-12-31

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.

Detailed Description

As the transcatheter aortic valve implantation (TAVI) procedure matures, complications such as paravalvular regurgitation (PVR), stroke, conduction disturbances, vascular complications, and annular rupture have been targeted for further improving the long-term outcome of TAVI. Paravalvular regurgitation (PVR) is associated with mortality following TAVI, even in those with mild PVR. Accurate procedural assessment of AR-critical for successful TAVI. Aortic root angiography, typically using Seller's visual grading, is the first screening tool used in most laboratories for the detection of post-implantation AR and guidance of timely corrective measures (e.g. post-dilation, valve-in-valve and, most recently, retrieval and reposition of the valve). However, the Sellers classification of aortic regurgitation (AR) is subjective. Some centers use transthoracic echo to confirm residual AR. However, performing transthoracic echo in the Cath-lab in a prone position is challenging. Previous studies have demonstrated that TAVI performed exclusively under angiographic guidance with backup TTE is feasible and associated with reasonably good outcomes, similar to those of angiography and TEE-guided procedures. Quantitative aortographic assessment of AR is important for procedural TAVI guidance to facilitate timely decision-making to avert AR using balloon post-dilatation, retrieval-reposition, or valve-in-valve implantation.

CAAS A-Valve (quantitative assessment of regurgitation with videodensitometry in the left ventricle outflow tract) is a new tool to quantify AR developed by Pie Medical. This tool is an angiographic methodology that proved to be accurate, feasible, reproducible, and predictive of outcomes after TAVI. After extensive validation of this new technology in two different cohorts (from the Brazilian TAVI registry and Bad-Segeberg, Germany), hereby we propose to apply this currently off-line technology to guide decision making in the Cath-lab during TAVI.

The present trial is a prospective, randomized, controlled, open-label, multi-center, non-inferiority trial. The primary objective of this trial is to determine whether TAVI procedure guided by videodensitometric assessment of aortography is non-inferior to TAVI implantation guided by Standard of care (usual practice) in terms of postprocedural quantitative aortic regurgitation. The primary endpoint of the study will be the Cardiac magnetic resonance-derived regurgitation fraction at discharge. This project is the first study to investigate the clinical utility of using video-densitometry in a randomized, controlled clinical trial to guide TAVI procedure. In centers with no current CAAS-A Valve software, Pie Medical will provide a research lease during the study period.

Conditions

Aortic Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Experimental arm

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

Group Type: EXPERIMENTAL

Videodensitometric guided

Intervention Type: 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

Control arm

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

Group Type: ACTIVE_COMPARATOR

Stand of care guided

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Subject has aortic stenosis with indication of TAVI implantation as determined by Heart Team.

2. Patient is at least 18 years of age.

3. Signed informed consent. The patient understands and accepts clinical follow-up.

Exclusion Criteria

1. Subject is not willing to provide an informed consent form, or whose legal heirs object to their participation in the study.

2. If the patient is not suitable for participating in the study, based on the evaluation by the operators.

3. Cardiogenic shock.

4. Significant comorbidities precluding clinical follow-up (as judged by investigators).

5. History of TAVI or SAVR.

6. Renal insufficiency (GFR/MDRD <45 ml/min), which precludes in operator's opinion contrast injection during repeat aortography.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ling Tao, MD, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ling Tao, PhD

Role: STUDY_CHAIR

Xijing Hospital, Xi'an, Shannxi, China

Junbo Ge, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhongshan hospital, Fudan University, Shanghai, China

Patrick Washington Serruys, PhD

Role: STUDY_CHAIR

National University of Ireland Galway, Galway, Ireland

Yoshinobu Onuma, Ph D

Role: STUDY_CHAIR

National University of Ireland Galway, Galway, Ireland

Daxin Zhou, PhD

Role: STUDY_CHAIR

Zhongshan hospital, Fudan University, Shanghai, China

Rutao Wang, PhD

Role: STUDY_CHAIR

Xijing Hospital, Xi'an, Shannxi, China

Locations

Zhongshan hospital, Fudan University

Shanghai, Shanghai Municipality, China

Xijing hospital

Xi'an, Shannxi, China

Countries

China

Other Identifiers

OVAL GUIDE CHINA

Identifier Type: -

Identifier Source: org_study_id