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

Videodensitometric Angiographic Assessment of AR in the Cath-lab for Intraprocedural Guidance of TAVI in CHINA-A Prospective, Randomized, Controlled, Open-label, Multi-centre, Non-inferiority Trial

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Aortic Stenosis
• Intervention / Treatment: Diagnostic test: Videodensitometric guided; Diagnostic test: Stand of care guided

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.

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital, Fudan University
  • Shannxi
    • Xi'an, Shannxi, China, 71000
      • Xijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental arm; TAVI procedure guided by post-implantation aortographic quantitative videodensitometric assessment.	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
Active Comparator: Control arm; TAVI procedure guided by post-implantation standard of care according to local practice.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CMR-derived regurgitation fraction	The Cardiac magnetic resonance-derived regurgitation fraction at discharge.	at discharge 1 day, an average of 7days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical cost	Direct medical cost at discharge	at discharge 1 day, an average of 7days
Radiation dose	Amount of radiation dose	during the procedure
Time in the Cathlab	Time in the Cathlab	during the procedure
Time for the TAVI procedure	Time for the TAVI procedure	during the procedure
All-cause mortality and its sub-categories	All-cause mortality and its sub-categories defined by VARC 3	at discharge 1 day, an average of 7days; 30-day; 1 year
All strokes	All strokes	at discharge 1 day, an average of 7days;30-day; 1 year
Any hospitalization and its sub-categories	Any hospitalization and its sub-categories defined by VARC 3	30-day, 1 year
Acute Kidney Injury (AKI)	Acute Kidney Injury (AKI)(VARC 3 criteria: use the widely recognized kidney disease: Improving Global Outcomes (KDIGO) definition of AKI)	at discharge 1 day, an average of 7days; 30-day
Type 3 (life-threatening) or Type 4 (leading to death) bleeding	Type 3 (life-threatening) or Type 4 (leading to death) bleeding (VARC-3 criteria)	at discharge 1 day, an average of 7days; 30-day; 1 year
Mild or more prosthetic valve regurgitation	Mild or more prosthetic valve regurgitation [TTE assessment	30-day, 1 year
New permanent pacemaker implantation	New permanent pacemaker implantation [VARC-3 criteria]	at discharge 1 day, an average of 7days; 30-day, 1 year
Conduction disturbances and arrhythmias	Conduction disturbances and arrhythmias according to VARC-3	at discharge 1 day, an average of 7days; 30-day; 1 year
Technical success:	Freedom from mortality; Successful access, delivery of the device, and retrieval of the delivery system; Correct positioning of a single prosthetic heart valve into the proper anatomical location; Freedom from surgery or intervention related to the devicea or to a major vascular or access-related, or cardiac structural complication	patient exit from procedure room,whichever came first,assessed up to 30 minutes
Device success	Technical success; Freedom from mortality; Freedom from surgery or intervention related to the devicea or to a major vascular or access-related or cardiac structural complication; Intended performance of the valvec (mean gradient <20 mmHg, peak velocity <3 m/s, Doppler velocity index >_0.25, and less than moderate aortic regurgitation)	30-day
Myocardial infarction	Myocardial infarction (VARC-3 criteria)	at discharge 1 day, an average of 7days; 30-day; 1 year
Vascular and access-related complications	Vascular and access-related complications (VARC-3 criteria)	at discharge 1 day, an average of 7days; 30-day; 1 year
Cardiac structural complications	Cardiac structural complications (VARC-3 criteria)	at discharge 1 day, an average of 7days; 30-day; 1 year
Any adverse events	Any adverse events	within 7 days

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Study Chair: Ling Tao, PhD, Xijing Hospital, Xi'an, Shannxi, China; Principal Investigator: Junbo Ge, PhD, Zhongshan Hospital, Fudan University, Shanghai, China; Study Chair: 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 record dates

Study Major Dates

• Study Start (Actual): March 28, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 16, 2025
• First Submitted That Met QC Criteria: March 21, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: transcatheter aortic valve implantation; Aortic stenosis; Paravalvular regurgitation; videodensitometry
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: OVAL GUIDE CHINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No