AORTIC VALVE DISEASESPhase 4TRAMPERSNCT06818084
TRanscAtheter TreatMent of PurE Aortic Regurgitation With VitaFlow Liberty System
A Phase 4 study testing VitaFlow+GDMT and J-Valve+GDMT in people with AORTIC VALVE DISEASES and Aortic Regurgitation, run by Ruijin Hospital at 4 sites in China.
Trial summary
This study is a prospective, multicenter, non-randomized controlled trial, planning to enroll 180 patients with pure native aortic regurgitation. On the basis of standardized medical therapy, patients will be assigned in a 1:1 ratio to undergo transfemoral transcatheter aortic valve replacement (TF-TAVR) . Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- AORTIC VALVE DISEASES, Aortic Regurgitation, Transcatheter Aortic Valve Replacement (TAVR)
- What is being tested?
- VitaFlow+GDMT and J-Valve+GDMT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesChina
- Study dates
- 29 Apr 2025to 30 Nov 2027
- Phase
- Phase 4
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria Age ≥ 60 years. Symptomatic moderate-to-severe or greater isolated aortic regurgitation.
Asymptomatic moderate-to-severe or greater isolated aortic regurgitation meeting at least one of the following criteria:
LVEF ≤ 55% (measured by biplane Simpson's method); LVESD > 50 mm ; LVESDi > 22 mm/mm²； LVESVi > 45mL/m2 Anatomical suitability for TAVR as assessed by the heart team. Provision of written informed consent by the patient or their legal guardian, with agreement to the treatment plan and willingness and ability to comply with all required follow-up assessments.
Exclusion Criteria Incomplete coronary revascularization. Less than 30 days of guideline-directed medical therapy at maximally tolerated doses.
Life expectancy < 1 year. LVEF < 45%. eGFR < 30 mL/min/1.73m². Known allergy or contraindication to required medications (e.g., aspirin, clopidogrel, warfarin) or contrast media.
Any condition that precludes contrast-enhanced CT. Concurrent moderate-to-severe or severe valvular heart disease other than aortic regurgitation.
Poor patient compliance, unable to complete follow-up as required. Any other condition that, in the investigator's judgment, would make the patient unsuitable for the study.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Ruijin hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Jiwei Yu, MD, 86-021-64370045, yjw12506@rjh.com.cn
ZhengBin Zhu, MD,PHD
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Yanjie Li, MD,PHD, 86-021-22200000, liyanjie6666@126.com
Xin Pan, MD
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Li Zhu, Deputy Chief Nurse, 86-021-64041990, zhu.li@zs-hospital.sh.cn
Li Zhu, Deputy Chief Nurse
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Zhu Ni, MD,PHD, 86-021-31166666, nizhu@outlook.com
Ni Zhu, MD,PHD
About this study
Official title: Transcatheter Treatment of Pure Aortic Regurgitation With VitaFlow Liberty System: a Prospective, Multicenter Study
This study is a prospective, multicenter, non-randomized controlled trial, planning to enroll 180 patients with pure native aortic regurgitation. On the basis of standardized medical therapy, patients will be assigned in a 1:1 ratio to undergo transfemoral transcatheter aortic valve replacement (TF-TAVR) . This prospective, multicenter trial aims to evaluate the safety and effectiveness of transfemoral TAVR using the VitaFlow™ self-expanding valve system compared to dedicated transcatheter devices in patients with PNAR.
The primary endpoint is a composite of all-cause mortality, disabling stroke, and rehospitalization for heart failure, myocardial Infarction, and requiring dialysis or valve reoperation at 12 months post-procedure.
Secondary endpoints include procedure-related complications, long-term clinical events, patient functional status and quality of life, bioprosthetic valve imaging follow-up, echocardiographic parameters, and treatment costs. All endpoint definitions conform to the Valve Academic Research Consortium-3 (VARC-3) criteria
Read the detailed description
The purpose of this study is to evaluate the safety and efficacy of TF-TAVR for the treatment of isolated aortic regurgitation. The study will compare all-cause mortality, cardiovascular mortality, stroke, rehospitalization for heart failure, and renal failure requiring dialysis treatment at 12 months after TAVR. Additionally, the study will assess the incidence of hypoattenuated leaflet thickening (HALT) and reduced leaflet motion (RLM) via CTA, as well as the aortic valve root-prosthesis coaxiality. Changes and differences between groups in the following parameters will be evaluated using transthoracic echocardiography at 6 and 12 months after enrollment: left ventricular ejection fraction (Simpson method), left ventricular end-diastolic volume index (LVEDVi), left ventricular end-systolic volume index (LVESVi), left ventricular end-diastolic diameter (LVEDd), left ventricular end-systolic diameter (LVESd), estimated aortic valve orifice area, valvular regurgitation, and transvalvular pressure gradient compared with baseline. The study will also compare changes and differences between groups in the Minnesota Living with Heart Failure Questionnaire, Social Support Rating Scale (SSRS), International Physical Activity Questionnaire (IPAQ), and 6-minute walk test (6MWT) at 6 and 12 months after enrollment compared with baseline. Furthermore, the study will compare surgical costs, potential complication costs, and disease-related costs between the two groups.
- Conditions
- AORTIC VALVE DISEASES, Aortic Regurgitation, Transcatheter Aortic Valve Replacement (TAVR)
- Being tested
- VitaFlow+GDMT, J-Valve+GDMT
- Keywords
- pure aortic regurgitation, Transcatheter aortic valve replacement (TAVR), hypoattenuated leaflet thickening, reduced leaflet motion
- Medical subject headings
- Aortic Valve Disease, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitaFlow+GDMTCombination product
The patient will undergo transcatheter aortic valve replacement on the basis of guideline-directed medical therapy with The VitaFlow™ system.
The VitaFlow™ system (MicroPort®, Shanghai, China) was a novel TAVR system, which incorporates high-radial force and a double layer polyethylene terephthalate (PET) skirt to optimize frame geometry and minimize the risks of paravalvular leak (PVL). The VitaFlow™ transcatheter aortic valve is made of a self-expanding nitinol frame and tri-leaflet bovine pericardial valve.
J-Valve+GDMTCombination product
The patient will undergo transfemoral aortic valve replacement on the basis of guideline-directed medical therapy with The J-Valve system (Jie ChengMedical Technologies, Suzhou, China). The J-Valve system is a second-generation self-expand able device composed of a porcine bioprosthetic aortic valve and a transfemoral delivery sheath. The valve is supported by a self-expanding nitinol structure. The different valve sizes are 21, 23, 25, 27, 29 and 34 mm. Three U-shaped nitinol graspers were designed to surround the valve.
| Study group | Role | What they receive |
|---|---|---|
| VitaFlow | Experimental | Patients who meet the inclusion and exclusion criteria will undergo TAVR using the VitaFlow™ self-expanding valve system. Receives: Combination Product: VitaFlow+GDMT |
| J-Valve | Active comparator | Patients who meet the inclusion and exclusion criteria will undergo TF-TAVR using dedicated transcatheter device J-Valve system. Receives: Combination Product: J-Valve+GDMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical worsening
The primary endpoint is a composite of all-cause mortality, disabling stroke, and rehospitalization for heart failure, myocardial Infarction, and requiring dialysis or valve reoperation at 12 months post-procedure.
Measured: 12 months
Secondary outcomes (14)
Rate of procedural complications
The rate of any aortic dissection, annular rupture, coronary artery occlusion, vascular complications, permanent pacemaker implantation, reoperation of heart valve.
Measured: 12 months
6-minute walk distance
This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.
Measured: 12 months
New York Heart Association (NYHA) functional class
Classification of function capacity of the NYHA.
Measured: 12 months
Rate of hypoattenuated leaflet thickening
The rate of hypoattenuated leaflet thickening. Hypoattenuated leaflet thickening（HALT）defined by VARC-3
Measured: 12 months
Rate of reduced leaflet motion
Rate of reduced leaflet motion. Reduced leaflet motion（RLM）defined by VARC-3.
Measured: 12 months
Rate of Stroke
Stroke is defined as an acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction.
Measured: 12 months
Mortality
All-cause, cardiovascular, and non-cardiovascular mortality
Measured: 12 months
Rate of bleeding complications
Rate of bleeding complications. The original VARC definitions with BARC classifications
Measured: 12 months
Rate of prothetic valve dysfunction
The rate of any prothetic aortic valve stenosis, prothesis-patient mismatch, prosthetic aortic valve regurgitation
Measured: 12 months
Rate of rehospitalization
The rate of rehospitalization due to valve-related symptoms or worsening congestive heart failure.
Measured: 12 months
Quality of life assessment (Minnesota Living with Heart Failure Questionnaire, MLHFQ)
Total score of Minnesota Living with Heart Failure Questionnaire (MLHFQ). The total score ranges from 0 to 105, with higher scores indicating a greater impact of heart failure on quality of life and worse outcome..
Measured: 12 months
Quality of life assessment (social supporting raing scal, SSRS)
Total score of social supporting raing scal (SSRS). The total score ranges from 0 to 40, with higher scores indicating a higher level of social support.
Measured: 12 months
Quality of life assessment (International Physical Activity Questionnaire, IPAQ)
Total score of International Physical Activity Questionnaire (IPAQ). The total score is calculated by multiplying the frequency and duration of each activity by its respective MET value, and then summing these products. The result is a measure of the total energy expenditure from physical activity in MET-minutes per week.The total score can be used to classify individuals into different physical activity levels, such as low, moderate, or high.
Measured: 12 months
Treatment costs
Including surgical costs, potential complications costs, and disease-related costs
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start29 Apr 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AORTIC VALVE DISEASESStudies of the same condition, open and under way.
- More trials run by Ruijin 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu zhengbin, Ruijin Hospital
- Investigators
- ZhengBin Zhu, MD. PhD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818084
- Sponsor's protocol ID
- 24SF1904800
- Other IDs
- 24SF1904800
- Acronym
- TRAMPERS
- Status last verified
- Dec 2025
- First submitted
- 25 Jan 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yu J, Zhu N, Zhu L, Pan X, Zhu Z; TRAMPERS investigators. Transcatheter treatment of pure aortic regurgitation with the VitaFlowTM Liberty system: design & rationale of the prospective, multicenter, non-randomized TRAMPERS study. Future Cardiol. 2026 Mar;22(3):229-236. doi: 10.1080/14796678.2026.2632486. Epub 2026 Feb 25.
PubMed 41739727
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Treatment of Pure Aortic Regurgitation With VitaFlow Liberty System: a Prospective, Multicenter Study
- ClinicalTrials.gov ID
- NCT06818084
- Acronym / sponsor ID
- TRAMPERS / 24SF1904800
- Conditions
- AORTIC VALVE DISEASES, Aortic Regurgitation, Transcatheter Aortic Valve Replacement (TAVR)
- Keywords
- pure aortic regurgitation, Transcatheter aortic valve replacement (TAVR), hypoattenuated leaflet thickening, reduced leaflet motion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 10 Feb 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 study is a prospective, multicenter, non-randomized controlled trial, planning to enroll 180 patients with pure native aortic regurgitation. On the basis of standardized medical therapy, patients will be assigned in a 1:1 ratio to undergo transfemoral transcatheter aortic valve replacement (TF-TAVR) . This prospective, multicenter trial aims to evaluate the safety and effectiveness of transfemoral TAVR using the VitaFlow™ self-expanding valve system compared to dedicated transcatheter devices in patients with PNAR.
The primary endpoint is a composite of all-cause mortality, disabling stroke, and rehospitalization for heart failure, myocardial Infarction, and requiring dialysis or valve reoperation at 12 months post-procedure.
Secondary endpoints include procedure-related complications, long-term clinical events, patient functional status and quality of life, bioprosthetic valve imaging follow-up, echocardiographic parameters, and treatment costs. All endpoint definitions conform to the Valve Academic Research Consortium-3 (VARC-3) criteria
Detailed description
The purpose of this study is to evaluate the safety and efficacy of TF-TAVR for the treatment of isolated aortic regurgitation. The study will compare all-cause mortality, cardiovascular mortality, stroke, rehospitalization for heart failure, and renal failure requiring dialysis treatment at 12 months after TAVR. Additionally, the study will assess the incidence of hypoattenuated leaflet thickening (HALT) and reduced leaflet motion (RLM) via CTA, as well as the aortic valve root-prosthesis coaxiality. Changes and differences between groups in the following parameters will be evaluated using transthoracic echocardiography at 6 and 12 months after enrollment: left ventricular ejection fraction (Simpson method), left ventricular end-diastolic volume index (LVEDVi), left ventricular end-systolic volume index (LVESVi), left ventricular end-diastolic diameter (LVEDd), left ventricular end-systolic diameter (LVESd), estimated aortic valve orifice area, valvular regurgitation, and transvalvular pressure gradient compared with baseline. The study will also compare changes and differences between groups in the Minnesota Living with Heart Failure Questionnaire, Social Support Rating Scale (SSRS), International Physical Activity Questionnaire (IPAQ), and 6-minute walk test (6MWT) at 6 and 12 months after enrollment compared with baseline. Furthermore, the study will compare surgical costs, potential complication costs, and disease-related costs between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VitaFlow | Experimental | Combination Product: VitaFlow+GDMTPatients who meet the inclusion and exclusion criteria will undergo TAVR using the VitaFlow™ self-expanding valve system. |
| J-Valve | Active comparator | Combination Product: J-Valve+GDMTPatients who meet the inclusion and exclusion criteria will undergo TF-TAVR using dedicated transcatheter device J-Valve system. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| VitaFlow+GDMTThe patient will undergo transcatheter aortic valve replacement on the basis of guideline-directed medical therapy with The VitaFlow™ system. The VitaFlow™ system (MicroPort®, Shanghai, China) was a novel TAVR system, which incorporates high-radial force and a double layer polyethylene terephthalate (PET) skirt to optimize frame geometry and minimize the risks of paravalvular leak (PVL). The VitaFlow™ transcatheter aortic valve is made of a self-expanding nitinol frame and tri-leaflet bovine pericardial valve. | Combination product | VitaFlow |
| J-Valve+GDMTThe patient will undergo transfemoral aortic valve replacement on the basis of guideline-directed medical therapy with The J-Valve system (Jie ChengMedical Technologies, Suzhou, China). The J-Valve system is a second-generation self-expand able device composed of a porcine bioprosthetic aortic valve and a transfemoral delivery sheath. The valve is supported by a self-expanding nitinol structure. The different valve sizes are 21, 23, 25, 27, 29 and 34 mm. Three U-shaped nitinol graspers were designed to surround the valve. | Combination product | J-Valve |
Primary outcome
Clinical worsening
Time frame: 12 months
The primary endpoint is a composite of all-cause mortality, disabling stroke, and rehospitalization for heart failure, myocardial Infarction, and requiring dialysis or valve reoperation at 12 months post-procedure.
14 secondary outcomes
Rate of procedural complications
Time frame: 12 months
6-minute walk distance
Time frame: 12 months
New York Heart Association (NYHA) functional class
Time frame: 12 months
Rate of hypoattenuated leaflet thickening
Time frame: 12 months
Rate of reduced leaflet motion
Time frame: 12 months
Rate of Stroke
Time frame: 12 months
Mortality
Time frame: 12 months
Rate of bleeding complications
Time frame: 12 months
Rate of prothetic valve dysfunction
Time frame: 12 months
Rate of rehospitalization
Time frame: 12 months
Quality of life assessment (Minnesota Living with Heart Failure Questionnaire, MLHFQ)
Time frame: 12 months
Quality of life assessment (social supporting raing scal, SSRS)
Time frame: 12 months
Quality of life assessment (International Physical Activity Questionnaire, IPAQ)
Time frame: 12 months
Treatment costs
Time frame: 12 months
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 30 Jan 2026.
- Derived from this study: PubMed 41739727Yu J, Zhu N, Zhu L, Pan X, Zhu Z; TRAMPERS investigators. Transcatheter treatment of pure aortic regurgitation with the VitaFlowTM Liberty system: design & rationale of the prospective, multicenter, non-randomized TRAMPERS study. Future Cardiol. 2026 Mar;22(3):229-236. doi: 10.1080/14796678.2026.2632486. Epub 2026 Feb 25.
- Individual participant dataSharing planned: Undecided
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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.
ZhengBin Zhu, MD. PhD principal investigator
Ruijin Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing VitaFlow+GDMT and J-Valve+GDMT in people with AORTIC VALVE DISEASES and Aortic Regurgitation, run by Ruijin Hospital at 4 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?
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 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zhengbin Zhu, MD. PhD. (0086-15601950612, zzb11561@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical worsening (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06818084, which also lists 1 linked publication.
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 30 Jan 2026.