Aortic Valve RegurgitationNCT06381271
Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation
An observational study of Aortic Valve Regurgitation, run by Xijing Hospital at 1 site in China.
Trial summary
The purpose of this multicenter, prospective and observational registry is to evaluate the safety and efficacy of TAVR for treatment of pure severe aortic valve regurgitation. Baseline characteristics, procedural and clinical data will be collected Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Regurgitation
- What is being tested?
- Transcatheter aortic valve replacement
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2018to Oct 2034
- 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: Patients with pure severe native aortic valve regurgitation underwent TAVR
Who may be able to join
- 1. Patients diagnosed with severe aortic valve regurgitation undergo evaluation by the Heart team and are eligible for TAVR therapy.
- 2. Patients who understand the purpose of this study, agree to participate in the trial and sign the informed consent form
Who cannot join
- 1. Patients who cannot provide informed consent
- 2. Patients who are treated with TAVR for aortic stenosis
- 3. Patients who are participating in other clinical trials
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
Xijing Hospital
Xi'an, Shannxi, 710032
Rutao Wang, M.D., Ph.D., +86-15091095796, rutaowang@qq.com
Ruining Zhang, BSc, +86-15802990370, ruining-zhang@qq.com
About this study
Official title: Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation: a Real-world, Prospective, Multicenter Study (TRUST TAVR Registry)
The purpose of this multicenter, prospective and observational registry is to evaluate the safety and efficacy of TAVR for treatment of pure severe aortic valve regurgitation. Baseline characteristics, procedural and clinical data will be collected
Read the detailed description
Pure native aortic valve regurgitation (NAVR) is a multifactorial valvular disease, with a prevalence of moderate or severe NAVR ranging from 0.5% to 2.7%. Patients with severe NAVR have a poor prognosis, conservative management has a 1-year mortality rate of more than 20%. Currently, surgical aortic valve replacement (SAVR) is the recommended treatment strategy for patients with NAVR. However, data showed that only 20% of patients with severe NAVR and left-ventricular ejection fraction (LVEF) of 30-50% undergo SAVR, while only 3% of those with an LVEF below 30% receive SAVR. Therefore, a less invasive surgical alternative therapy is needed for high surgical-risk patients from SAVR.
Transcatheter aortic valve replacement (TAVR) is now considered the first-choice treatment for elderly patients with aortic stenosis, regardless of surgical risk. Recently, it has also been used to treat patients with NAVR in an "off-label" setting. The latest European guidelines suggest that TAVR may be considered in experienced centers for selected patients with AR who are not eligible for SAVR. However, the role of TAVR in patients with severe NAVR is still debatable. Current studies on this topic are limited by their retrospective design and small sample sizes.
Dedicated devices for aortic regurgitation, such as the JenaValve, have shown promising results in terms of technical success and short-term outcomes. However, TAVR for patients with NAVR using on-label devices has a relatively high rate of pacemaker implantation. Additionally, the dedicated device was designed only for tricuspid valve anatomy, making TAVR with off-label devices the main invasive strategy for high-surgical risk patients with bicuspid valves. It's worth noting that the dedicated device is not yet commercially available worldwide. Therefore, further investigation into TAVR using off-label devices for NAVR patients, including those with bicuspid and tricuspid valves, is necessary.
The objective of this study was to evaluate the safety and efficacy of TAVR in patients with NAVR in a real-world setting.
- Conditions
- Aortic Valve Regurgitation
- Being tested
- Transcatheter aortic valve replacement
- Keywords
- Aortic Valve Regurgitation, TAVR, Real-Word
- Medical subject headings
- Aortic Valve Insufficiency
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 500 consecutive patients with NAVR undergoing TAVR will be enrolled at 3-5 centers. Clinical follow-up will be conducted in the periprocedural and after aortic valve implantation at 1 month, 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 clinical efficacy outcomes
Combined clinical efficacy outcomes as composed by all-cause mortality, all strokes, any hospitalization
Measured: 1 year
Secondary outcomes (6)
Combined early safety and clinical efficacy outcomes
Composed by all-cause mortality, all strokes, life-threatening or fatal bleeding, major vascular, access-related, or cardiac structural complication, acute kidney injury stage 3 or 4, moderate or severe aortic regurgitation, new permanent pacemaker due to procedure-related conduction abnormalities, conduction block and arrhythmia, surgery or intervention related to the device, any hospitalization, myocardial infarction, any other adverse events
Measured: 30 days
Rate of 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 device or to a major vascular or access-related, or cardiac structural complication
Measured: at exit from procedure room
Rate of 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, and less than moderate aortic regurgitation)
Measured: discharge or 30 days
Combined clinical efficacy outcomes
Combined clinical efficacy outcomes as composed by all-cause mortality, all strokes, any hospitalization
Measured: 2 years, 3 years, 4 years
Rate of all-cause mortality
Measured: 5years and 10years
Valve-related long-term clinical efficacy
- Freedom from bioprosthetic Valve Failure (defined as: Valve-related mortality OR Aortic valve re-operation/re-intervention OR Stage 3 hemodynamic valve deterioration)
- Freedom from stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies)
- Freedom from VARC Type 2-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents, used specifically for valve-related concerns (e.g. clinically apparent leaflet thrombosis)
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 posted24 Apr 2024
- Study start30 Oct 2018
- Primary completionOct 2034 (estimated)
- Study completionOct 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 RegurgitationStudies 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
- 500 participants (estimated)
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
- NCT06381271
- Sponsor's protocol ID
- TRUST TAVR Registry
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- 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 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation: a Real-world, Prospective, Multicenter Study (TRUST TAVR Registry)
- ClinicalTrials.gov ID
- NCT06381271
- Acronym / sponsor ID
- TRUST TAVR Registry
- Conditions
- Aortic Valve Regurgitation
- Keywords
- Aortic Valve Regurgitation, TAVR, Real-Word
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- Oct 2034 (estimated)
- Study completion
- Oct 2034 (estimated)
- First posted
- 24 Apr 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 multicenter, prospective and observational registry is to evaluate the safety and efficacy of TAVR for treatment of pure severe aortic valve regurgitation. Baseline characteristics, procedural and clinical data will be collected
Detailed description
Pure native aortic valve regurgitation (NAVR) is a multifactorial valvular disease, with a prevalence of moderate or severe NAVR ranging from 0.5% to 2.7%. Patients with severe NAVR have a poor prognosis, conservative management has a 1-year mortality rate of more than 20%. Currently, surgical aortic valve replacement (SAVR) is the recommended treatment strategy for patients with NAVR. However, data showed that only 20% of patients with severe NAVR and left-ventricular ejection fraction (LVEF) of 30-50% undergo SAVR, while only 3% of those with an LVEF below 30% receive SAVR. Therefore, a less invasive surgical alternative therapy is needed for high surgical-risk patients from SAVR.
Transcatheter aortic valve replacement (TAVR) is now considered the first-choice treatment for elderly patients with aortic stenosis, regardless of surgical risk. Recently, it has also been used to treat patients with NAVR in an "off-label" setting. The latest European guidelines suggest that TAVR may be considered in experienced centers for selected patients with AR who are not eligible for SAVR. However, the role of TAVR in patients with severe NAVR is still debatable. Current studies on this topic are limited by their retrospective design and small sample sizes.
Dedicated devices for aortic regurgitation, such as the JenaValve, have shown promising results in terms of technical success and short-term outcomes. However, TAVR for patients with NAVR using on-label devices has a relatively high rate of pacemaker implantation. Additionally, the dedicated device was designed only for tricuspid valve anatomy, making TAVR with off-label devices the main invasive strategy for high-surgical risk patients with bicuspid valves. It's worth noting that the dedicated device is not yet commercially available worldwide. Therefore, further investigation into TAVR using off-label devices for NAVR patients, including those with bicuspid and tricuspid valves, is necessary.
The objective of this study was to evaluate the safety and efficacy of TAVR in patients with NAVR in a real-world setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pure severe native aortic valve regurgitation underwent TAVR
Key inclusion criteria (2 listed)
- 1. Patients diagnosed with severe aortic valve regurgitation undergo evaluation by the Heart team and are eligible for TAVR therapy.
- 2. Patients who understand the purpose of this study, agree to participate in the trial and sign the informed consent form
Key exclusion criteria (3 listed)
- 1. Patients who cannot provide informed consent
- 2. Patients who are treated with TAVR for aortic stenosis
- 3. Patients who are participating in other clinical trials
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 500 consecutive patients with NAVR undergoing TAVR will be enrolled at 3-5 centers. Clinical follow-up will be conducted in the periprocedural and after aortic valve implantation at 1 month, 1 year, 2 years, 3 years, 4 years, 5 years, and 10 years | Procedure or surgery | – |
Primary outcome
Combined clinical efficacy outcomes
Time frame: 1 year
Combined clinical efficacy outcomes as composed by all-cause mortality, all strokes, any hospitalization
6 secondary outcomes
Combined early safety and clinical efficacy outcomes
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 clinical efficacy outcomes
Time frame: 2 years, 3 years, 4 years
Rate of all-cause mortality
Time frame: 5years and 10years
Valve-related long-term clinical efficacy
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 24 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 Regurgitation, 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 3 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 24 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 clinical efficacy outcomes (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 24 Apr 2024.