TRanscAtheter TreatMent of PurE Aortic Regurgitation With VitaFlow Liberty System (TRAMPERS)

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

Study Overview

• Status: Recruiting
• Conditions: Aortic Regurgitation; AORTIC VALVE DISEASES; Transcatheter Aortic Valve Replacement (TAVR)
• Intervention / Treatment: Combination product: VitaFlow+GDMT; Combination product: J-Valve+GDMT

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Zhengbin Zhu, MD. PhD.; Phone Number: 0086-15601950612; Email: zzb11561@rjh.com.cn
• Study Contact Backup: Name: Jiwei Yu, MD; Phone Number: 0086-13761292857; Email: yjw12506@rjh.com.cn

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: Li Zhu, Deputy Chief Nurse; Phone Number: 86-021-64041990; Email: zhu.li@zs-hospital.sh.cn
      • Principal Investigator: Li Zhu, Deputy Chief Nurse
    • Shanghai, Shanghai Municipality, China, 200433
      • Recruiting
      • Changhai Hospital
      • Contact: Zhu Ni, MD,PHD; Phone Number: 86-021-31166666; Email: nizhu@outlook.com
      • Principal Investigator: Ni Zhu, MD,PHD
    • Shanghai, Shanghai Municipality, China, 200025
      • Recruiting
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
      • Contact: Jiwei Yu, MD; Phone Number: 86-021-64370045; Email: yjw12506@rjh.com.cn
      • Principal Investigator: ZhengBin Zhu, MD,PHD
    • Shanghai, Shanghai Municipality, China, 200030
      • Recruiting
      • Shanghai Chest Hospital
      • Contact: Yanjie Li, MD,PHD; Phone Number: 86-021-22200000; Email: liyanjie6666@126.com
      • Principal Investigator: Xin Pan, MD

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VitaFlow; Patients who meet the inclusion and exclusion criteria will undergo TAVR using the VitaFlow™ self-expanding valve system.	Combination product: VitaFlow+GDMT; 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.
Active Comparator: J-Valve; Patients who meet the inclusion and exclusion criteria will undergo TF-TAVR using dedicated transcatheter device J-Valve system.	Combination product: J-Valve+GDMT; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
New York Heart Association (NYHA) functional class	Classification of function capacity of the NYHA.	12 months
Mortality	All-cause, cardiovascular, and non-cardiovascular mortality	12 months
Rate of procedural complications	The rate of any aortic dissection, annular rupture, coronary artery occlusion, vascular complications, permanent pacemaker implantation, reoperation of heart valve.	12 months
Rate of hypoattenuated leaflet thickening	The rate of hypoattenuated leaflet thickening. Hypoattenuated leaflet thickening（HALT）defined by VARC-3	12 months
Rate of reduced leaflet motion	Rate of reduced leaflet motion. Reduced leaflet motion（RLM）defined by VARC-3.	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.	12 months
Rate of bleeding complications	Rate of bleeding complications. The original VARC definitions with BARC classifications	12 months
Rate of prothetic valve dysfunction	The rate of any prothetic aortic valve stenosis, prothesis-patient mismatch, prosthetic aortic valve regurgitation	12 months
Rate of rehospitalization	The rate of rehospitalization due to valve-related symptoms or worsening congestive heart failure.	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..	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.	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.	12 months
Treatment costs	Including surgical costs, potential complications costs, and disease-related costs	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left ventricular ejection fraction (Simpson's method)	Transthoracic echocardiography measurement of left ventricular ejection fraction (Simpson's method). Unit: %	12 months
Left ventricular end-diastolic volume index	Transthoracic echocardiography measurement left ventricular end-diastolic volume index (LVEDVi). Unit: milliliters per square meter (mL/m²)	12 months
Left ventricular end-systolic volume index	Transthoracic echocardiography measurements of left ventricular end-systolic volume index (LVESVi). Unit: milliliters per square meter (mL/m²)	12 months
Left ventricular end-diastolic diameter	Transthoracic echocardiography measurements of left ventricular end-diastolic diameter (LVEDd). Unit: millimeters	12 months
Left ventricular end-systolic diameter	Transthoracic echocardiography measurements of left ventricular end-systolic diameter (LVESd). Unit: millimeters	12 months
Aortic valve orifice area	Transthoracic echocardiography measurement of aortic valve orifice area. Unit: square centimeters	12 months
Transvalvular pressure gradient of aortic valve	Transthoracic echocardiography measurement of transvalvular pressure gradient of aortic valve. Unit: mmHg	12 months

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Principal Investigator: ZhengBin Zhu, MD. PhD, Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: January 25, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): February 10, 2025

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Transcatheter aortic valve replacement (TAVR); pure aortic regurgitation; hypoattenuated leaflet thickening; reduced leaflet motion
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Aortic Valve Disease; Aortic Valve Insufficiency
• Other Study ID Numbers: 24SF1904800 (Other Identifier: Shanghai Science & Technology Commission)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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