Aortic Valve Disease MixedNCT06257043
Safety and Efficacy of Post-marketing Transcatheter Aortic Valves in "Real World" Chinese Patients
An observational study of Aortic Valve Disease Mixed, run by Xijing Hospital at 1 site in China.
Trial summary
The purpose of this prospective multi-center, observational registry in China is to collect clinical baseline, procedural, and follow-up data of all patients treated with TAVR in China and to evaluate short-, mid-, and long-term clinical outcome data of all post-marketing transcatheter valves. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease Mixed
- What is being tested?
- Transcatheter aortic valve replacement
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2023to 1 Jan 2034
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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
Study population: Consecutive patients with aortic valve disease who are evaluated by the cardiac team for TAVR treatment
Who may be able to join
- Patients with aortic valve disease are evaluated by the cardiac team and indicate TAVR therapy
- Patients who understand the purpose of this study, voluntarily participate in the trial and sign the informed consent form
Who cannot join
- Patients with aortic valve disease who have been evaluated by a cardiac team as unsuitable for TAVR
- Patients who cannot tolerate the materials or medications associated with this study
- Women who are pregnant or breastfeeding
- Patients who participated in a clinical trial of another drug or medical device before enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ling Tao
Xi'an, Shaanxi, 710032
Rutao Wang, M.D., Ph.D., +86-15091095796, rutaowang@qq.com
About this study
Official title: RECORD TAVR REGISTRY: Prospective, Multi-Center Registry of "Real World" Chinese Patients Undergoing Transcatheter Aortic Valve Replacement
The purpose of this prospective multi-center, observational registry in China is to collect clinical baseline, procedural, and follow-up data of all patients treated with TAVR in China and to evaluate short-, mid-, and long-term clinical outcome data of all post-marketing transcatheter valves. Each center will collect baseline and procedural data as well as clinical outcomes for up to 10 years.
Read the detailed description
Aortic stenosis is the most clinically important valvular heart disease in the elderly, with severe aortic stenosis accounting for about 3.4%-5% of elderly patients. Patients with chest pain, congestive heart failure, or syncope who do not undergo surgical intervention have a poor prognosis, with a 1-year mortality rate as high as 50%. However, the high surgical risk of surgical valve replacement for elderly patients with multiple underlying diseases limits the use of surgical valve replacement, and the prognosis of high-risk surgical patients is poor. The PARTNER series of studies and the US CoreValve high-risk studies confirm that perioperative and postoperative adverse events in patients undergoing TAVR in surgical high-risk patients are comparable to those in surgical valve replacement. With technological advances, the indications for TAVR have been expanded from surgical high-risk to low to moderate-risk populations. Based on the PARTNER 3 and Evolut Low Risk studies, FDA approved the use of TAVR to treat low surgical risk patients with symptomatic severe aortic stenosis. Recently, TAVR has also been expanded to patients with aortic valve regurgitation.
With a population of 1.4 billion, China has a large number of patients with aortic valve disease, but the TAVR program was launched in 2010. No large-scale TAVR studies are available to validate the efficacy and safety of TAVR in the Chinese population. The morphological characteristics of valves in our patients bring great challenges to the operation and application of TAVR. However, through the efforts of Chinese experts and scholars, TAVR technology in China has developed rapidly, and various domestic valves with independent intellectual property have been marketed, bringing new opportunities for the promotion and application of TAVR in China. Domestic valves have been designed for the Chinese aortic valve anatomy, which is theoretically more suitable for the Chinese population. However, the efficacy and safety of these valves still need to be further confirmed in large clinical studies.
This multi-center registry study aims to evaluate the safety and efficacy of all post-marketing transcatheter valves in Chinese patients with aortic valve disease mixed. Investigators will collect baseline and procedural data, and evaluate the short-, mid-, and long-term clinical outcomes of TAVR in a large real-world population.
- Conditions
- Aortic Valve Disease Mixed
- Being tested
- Transcatheter aortic valve replacement
- Keywords
- Aortic Valve Disease, Real world, TAVR
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter aortic valve replacementProcedure or surgery
Also called Transcatheter aortic valve implantation
A total of 3000 consecutive patients with aortic valve disease undergoing TAVR will be enrolled at 30-50 centers. The devices used will be all post-market transcatheter aortic valves approved for use in China. Clinical follow-up will be conducted in the periprocedural and after aortic valve implantation at 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, and 10 years
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined early safety and clinical efficacy outcomes as defined by the Valve Academic Research Consortium-3 (VARC-3)
Composed by all-cause mortality, all strokes, any hospitalization, myocardial infarction
Measured: 1 year
Secondary outcomes (5)
Combined early safety and clinical efficacy outcomes as defined by the Valve Academic Research Consortium-3 (VARC-3)
Composed by all-cause mortality, all strokes, any hospitalization, myocardial infarction, acute kidney injury, life-threatening or fatal bleeding, mild or greater prosthetic valve regurgitation, new permanent pacemaker implantation, conduction block and arrhythmia, vascular and access-related complications, structural cardiac complications, any other adverse events
Measured: 30 days
Rate of technical success
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: at exit from procedure room
Rate of device success
Device success
- Technical success
- Freedom from mortality
- Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication
- Intended performance of the valve (mean gradient <20mmHg, peak velocity <3 m/s, Doppler velocity index >_0.25, and less than moderate aortic regurgitation)
Measured: discharge or 30 days
Combined safety and clinical efficacy outcomes as defined by the Valve Academic Research Consortium-3 (VARC-3)
Composed by all-cause mortality, all strokes, any hospitalization, myocardial infarction, life-threatening or fatal bleeding, mild or greater prosthetic valve regurgitation, new permanent pacemaker implantation, conduction block and arrhythmia, any other adverse events
Measured: 2 years, 3 years, 4 years
Combined safety and clinical efficacy outcomes as defined by the Valve Academic Research Consortium-3 (VARC-3)
Composed by all-cause mortality, all strokes, any hospitalization, myocardial infarction, life-threatening or fatal bleeding, mild or greater prosthetic valve regurgitation, new permanent pacemaker implantation, conduction block and arrhythmia, structural valve deterioration, any other adverse events
Measured: 5 years and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start30 Oct 2023
- Primary completion1 Nov 2033 (estimated)
- Study completion1 Jan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve Disease MixedStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LingTao, Xijing Hospital
- Investigators
- Ling Tao, M.D, Ph.D, Study chair, Xijing HospitalRutao Wang, M.D, Ph.D, Study chair, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257043
- Sponsor's protocol ID
- RECORD TAVR REGISTRY
- Status last verified
- Apr 2024
- First submitted
- 21 Dec 2023
- Last updated
- 19 Apr 2024
- 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 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECORD TAVR REGISTRY: Prospective, Multi-Center Registry of "Real World" Chinese Patients Undergoing Transcatheter Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT06257043
- Acronym / sponsor ID
- RECORD TAVR REGISTRY
- Conditions
- Aortic Valve Disease Mixed
- Keywords
- Aortic Valve Disease, Real world, TAVR
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 1 Nov 2033 (estimated)
- Study completion
- 1 Jan 2034 (estimated)
- First posted
- 13 Feb 2024 (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.
The purpose of this prospective multi-center, observational registry in China is to collect clinical baseline, procedural, and follow-up data of all patients treated with TAVR in China and to evaluate short-, mid-, and long-term clinical outcome data of all post-marketing transcatheter valves. Each center will collect baseline and procedural data as well as clinical outcomes for up to 10 years.
Detailed description
Aortic stenosis is the most clinically important valvular heart disease in the elderly, with severe aortic stenosis accounting for about 3.4%-5% of elderly patients. Patients with chest pain, congestive heart failure, or syncope who do not undergo surgical intervention have a poor prognosis, with a 1-year mortality rate as high as 50%. However, the high surgical risk of surgical valve replacement for elderly patients with multiple underlying diseases limits the use of surgical valve replacement, and the prognosis of high-risk surgical patients is poor. The PARTNER series of studies and the US CoreValve high-risk studies confirm that perioperative and postoperative adverse events in patients undergoing TAVR in surgical high-risk patients are comparable to those in surgical valve replacement. With technological advances, the indications for TAVR have been expanded from surgical high-risk to low to moderate-risk populations. Based on the PARTNER 3 and Evolut Low Risk studies, FDA approved the use of TAVR to treat low surgical risk patients with symptomatic severe aortic stenosis. Recently, TAVR has also been expanded to patients with aortic valve regurgitation.
With a population of 1.4 billion, China has a large number of patients with aortic valve disease, but the TAVR program was launched in 2010. No large-scale TAVR studies are available to validate the efficacy and safety of TAVR in the Chinese population. The morphological characteristics of valves in our patients bring great challenges to the operation and application of TAVR. However, through the efforts of Chinese experts and scholars, TAVR technology in China has developed rapidly, and various domestic valves with independent intellectual property have been marketed, bringing new opportunities for the promotion and application of TAVR in China. Domestic valves have been designed for the Chinese aortic valve anatomy, which is theoretically more suitable for the Chinese population. However, the efficacy and safety of these valves still need to be further confirmed in large clinical studies.
This multi-center registry study aims to evaluate the safety and efficacy of all post-marketing transcatheter valves in Chinese patients with aortic valve disease mixed. Investigators will collect baseline and procedural data, and evaluate the short-, mid-, and long-term clinical outcomes of TAVR in a large real-world population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with aortic valve disease who are evaluated by the cardiac team for TAVR treatment
Key inclusion criteria (2 listed)
- Patients with aortic valve disease are evaluated by the cardiac team and indicate TAVR therapy
- Patients who understand the purpose of this study, voluntarily participate in the trial and sign the informed consent form
Key exclusion criteria (4 listed)
- Patients with aortic valve disease who have been evaluated by a cardiac team as unsuitable for TAVR
- Patients who cannot tolerate the materials or medications associated with this study
- Women who are pregnant or breastfeeding
- Patients who participated in a clinical trial of another drug or medical device before enrollment
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 |
|---|---|---|
| Transcatheter aortic valve replacementAlso: Transcatheter aortic valve implantationA total of 3000 consecutive patients with aortic valve disease undergoing TAVR will be enrolled at 30-50 centers. The devices used will be all post-market transcatheter aortic valves approved for use in China. Clinical follow-up will be conducted in the periprocedural and after aortic valve implantation at 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, and 10 years | Procedure or surgery | – |
Primary outcome
Combined early safety and clinical efficacy outcomes as defined by the Valve Academic Research Consortium-3 (VARC-3)
Time frame: 1 year
Composed by all-cause mortality, all strokes, any hospitalization, myocardial infarction
5 secondary outcomes
Combined early safety and clinical efficacy outcomes as defined by the Valve Academic Research Consortium-3 (VARC-3)
Time frame: 30 days
Rate of technical success
Time frame: at exit from procedure room
Rate of device success
Time frame: discharge or 30 days
Combined safety and clinical efficacy outcomes as defined by the Valve Academic Research Consortium-3 (VARC-3)
Time frame: 2 years, 3 years, 4 years
Combined safety and clinical efficacy outcomes as defined by the Valve Academic Research Consortium-3 (VARC-3)
Time frame: 5 years and 10 years
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 19 Apr 2024.
- 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, M.D, Ph.D study chair
Xijing Hospital
Rutao Wang, M.D, Ph.D study chair
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Disease Mixed, run by Xijing Hospital at 1 site 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Rutao Wang, M.D, Ph.D (+86-15091095796, rutaowang@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined early safety and clinical efficacy outcomes as defined by the Valve Academic Research Consortium-3 (VARC-3) (time frame: 1 year). 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 19 Apr 2024.