Aortic StenosisNCT06891079
Videodensitometric Angiographic Assessment of AR in the Cath-lab for Intraprocedural Guidance of TAVI in CHINA
A study testing Videodensitometric guided and Stand of care guided in people with Aortic Stenosis, run by Xijing Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Videodensitometric guided and Stand of care guided
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 2 sitesChina
- Study dates
- 28 Mar 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Zhongshan hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Xijing hospital
Xi'an, Shannxi, 71000
About this study
Official title: 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.
Read the 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
- Being tested
- Videodensitometric guided, Stand of care guided
- Keywords
- Aortic stenosis, transcatheter aortic valve implantation, videodensitometry, Paravalvular regurgitation
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videodensitometric guidedDiagnostic 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
Stand of care guidedDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | TAVI procedure guided by post-implantation aortographic quantitative videodensitometric assessment. Receives: Diagnostic Test: Videodensitometric guided |
| Control arm | Active comparator | TAVI procedure guided by post-implantation standard of care according to local practice. Receives: Diagnostic Test: Stand of care guided |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMR-derived regurgitation fraction
The Cardiac magnetic resonance-derived regurgitation fraction at discharge.
Measured: at discharge 1 day, an average of 7days
Secondary outcomes (18)
Medical cost
Direct medical cost at discharge
Measured: at discharge 1 day, an average of 7days
Radiation dose
Amount of radiation dose
Measured: during the procedure
Time in the Cathlab
Time in the Cathlab
Measured: during the procedure
Time for the TAVI procedure
Time for the TAVI procedure
Measured: during the procedure
All-cause mortality and its sub-categories
All-cause mortality and its sub-categories defined by VARC 3
Measured: at discharge 1 day, an average of 7days; 30-day; 1 year
All strokes
All strokes
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 30-day, 1 year
New permanent pacemaker implantation
New permanent pacemaker implantation [VARC-3 criteria]
Measured: at discharge 1 day, an average of 7days; 30-day, 1 year
Conduction disturbances and arrhythmias
Conduction disturbances and arrhythmias according to VARC-3
Measured: 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
Measured: 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)
Measured: 30-day
Myocardial infarction
Myocardial infarction (VARC-3 criteria)
Measured: 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)
Measured: at discharge 1 day, an average of 7days; 30-day; 1 year
Cardiac structural complications
Cardiac structural complications (VARC-3 criteria)
Measured: at discharge 1 day, an average of 7days; 30-day; 1 year
Any adverse events
Any adverse events
Measured: within 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start28 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Tao, MD, PhD, Xijing Hospital
- Investigators
- Ling Tao, PhD, Study chair, Xijing Hospital, Xi'an, Shannxi, ChinaJunbo Ge, PhD, Principal investigator, Zhongshan hospital, Fudan University, Shanghai, ChinaPatrick Washington Serruys, PhD, Study chair, National University of Ireland Galway, Galway, IrelandYoshinobu Onuma, Ph D, Study chair, National University of Ireland Galway, Galway, IrelandDaxin Zhou, PhD, Study chair, Zhongshan hospital, Fudan University, Shanghai, ChinaRutao Wang, PhD, Study chair, Xijing Hospital, Xi'an, Shannxi, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891079
- Sponsor's protocol ID
- OVAL GUIDE CHINA
- Status last verified
- Mar 2025
- First submitted
- 16 Feb 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06891079
- Acronym / sponsor ID
- OVAL GUIDE CHINA
- Conditions
- Aortic Stenosis
- Keywords
- Aortic stenosis, transcatheter aortic valve implantation, videodensitometry, Paravalvular regurgitation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Diagnostic Test: Videodensitometric guidedTAVI procedure guided by post-implantation aortographic quantitative videodensitometric assessment. |
| Control arm | Active comparator | Diagnostic Test: Stand of care guidedTAVI procedure guided by post-implantation standard of care according to local practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Videodensitometric guidedIn 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 | Experimental arm |
| Stand of care guidedIn 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. | Diagnostic test | Control arm |
Primary outcome
CMR-derived regurgitation fraction
Time frame: at discharge 1 day, an average of 7days
The Cardiac magnetic resonance-derived regurgitation fraction at discharge.
18 secondary outcomes
Medical cost
Time frame: at discharge 1 day, an average of 7days
Radiation dose
Time frame: during the procedure
Time in the Cathlab
Time frame: during the procedure
Time for the TAVI procedure
Time frame: during the procedure
All-cause mortality and its sub-categories
Time frame: at discharge 1 day, an average of 7days; 30-day; 1 year
All strokes
Time frame: at discharge 1 day, an average of 7days;30-day; 1 year
Any hospitalization and its sub-categories
Time frame: 30-day, 1 year
Acute Kidney Injury (AKI)
Time frame: at discharge 1 day, an average of 7days; 30-day
Type 3 (life-threatening) or Type 4 (leading to death) bleeding
Time frame: at discharge 1 day, an average of 7days; 30-day; 1 year
Mild or more prosthetic valve regurgitation
Time frame: 30-day, 1 year
New permanent pacemaker implantation
Time frame: at discharge 1 day, an average of 7days; 30-day, 1 year
Conduction disturbances and arrhythmias
Time frame: at discharge 1 day, an average of 7days; 30-day; 1 year
Technical success:
Time frame: patient exit from procedure room,whichever came first,assessed up to 30 minutes
Device success
Time frame: 30-day
Myocardial infarction
Time frame: at discharge 1 day, an average of 7days; 30-day; 1 year
Vascular and access-related complications
Time frame: at discharge 1 day, an average of 7days; 30-day; 1 year
Cardiac structural complications
Time frame: at discharge 1 day, an average of 7days; 30-day; 1 year
Any adverse events
Time frame: within 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ling Tao, PhD study chair
Xijing Hospital, Xi'an, Shannxi, China
Junbo Ge, PhD principal investigator
Zhongshan hospital, Fudan University, Shanghai, China
Patrick Washington Serruys, PhD study chair
National University of Ireland Galway, Galway, Ireland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videodensitometric guided and Stand of care guided in people with Aortic Stenosis, run by Xijing Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMR-derived regurgitation fraction (time frame: at discharge 1 day, an average of 7days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.