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NCT Number: NCT06818084

TRanscAtheter TreatMent of PurE Aortic Regurgitation With VitaFlow Liberty System

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

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Key information

Conditions

AORTIC VALVE DISEASES Aortic Regurgitation Aortic Valve Disease Aortic Valve Insufficiency Cardiovascular Diseases Heart Diseases Heart Valve Diseases Transcatheter Aortic Valve Replacement (TAVR)

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Changhai Hospital, Shanghai, Shanghai Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VitaFlow+GDMT

Combination 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+GDMT

Combination 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Rate of procedural complications

    Time frame: 12 months

    The rate of any aortic dissection, annular rupture, coronary artery occlusion, vascular complications, permanent pacemaker implantation, reoperation of heart valve.

  2. 6-minute walk distance

    Time frame: 12 months

    This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.

  3. New York Heart Association (NYHA) functional class

    Time frame: 12 months

    Classification of function capacity of the NYHA.

  4. Rate of hypoattenuated leaflet thickening

    Time frame: 12 months

    The rate of hypoattenuated leaflet thickening. Hypoattenuated leaflet thickening（HALT）defined by VARC-3

  5. Rate of reduced leaflet motion

    Time frame: 12 months

    Rate of reduced leaflet motion. Reduced leaflet motion（RLM）defined by VARC-3.

  6. Rate of Stroke

    Time frame: 12 months

    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.

  7. Mortality

    Time frame: 12 months

    All-cause, cardiovascular, and non-cardiovascular mortality

  8. Rate of bleeding complications

    Time frame: 12 months

    Rate of bleeding complications. The original VARC definitions with BARC classifications

  9. Rate of prothetic valve dysfunction

    Time frame: 12 months

    The rate of any prothetic aortic valve stenosis, prothesis-patient mismatch, prosthetic aortic valve regurgitation

  10. Rate of rehospitalization

    Time frame: 12 months

    The rate of rehospitalization due to valve-related symptoms or worsening congestive heart failure.

  11. Quality of life assessment (Minnesota Living with Heart Failure Questionnaire, MLHFQ)

    Time frame: 12 months

    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. Quality of life assessment (social supporting raing scal, SSRS)

    Time frame: 12 months

    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.

  13. Quality of life assessment (International Physical Activity Questionnaire, IPAQ)

    Time frame: 12 months

    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.

  14. Treatment costs

    Time frame: 12 months

    Including surgical costs, potential complications costs, and disease-related costs

Other outcomes

  1. Left ventricular ejection fraction (Simpson's method)

    Time frame: 12 months

    Transthoracic echocardiography measurement of left ventricular ejection fraction (Simpson's method).

    Unit: %

  2. Left ventricular end-diastolic volume index

    Time frame: 12 months

    Transthoracic echocardiography measurement left ventricular end-diastolic volume index (LVEDVi).

    Unit: milliliters per square meter (mL/m²)

  3. Left ventricular end-systolic volume index

    Time frame: 12 months

    Transthoracic echocardiography measurements of left ventricular end-systolic volume index (LVESVi).

    Unit: milliliters per square meter (mL/m²)

  4. Left ventricular end-diastolic diameter

    Time frame: 12 months

    Transthoracic echocardiography measurements of left ventricular end-diastolic diameter (LVEDd).

    Unit: millimeters

  5. Left ventricular end-systolic diameter

    Time frame: 12 months

    Transthoracic echocardiography measurements of left ventricular end-systolic diameter (LVESd).

    Unit: millimeters

  6. Aortic valve orifice area

    Time frame: 12 months

    Transthoracic echocardiography measurement of aortic valve orifice area. Unit: square centimeters

  7. Transvalvular pressure gradient of aortic valve

    Time frame: 12 months

    Transthoracic echocardiography measurement of transvalvular pressure gradient of aortic valve.

    Unit: mmHg

Study contacts

Contact information is provided by the study sponsor or research team.

Jiwei Yu, MD

CONTACT

[email protected]

0086-13761292857

Zhengbin Zhu, MD. PhD.

CONTACT

[email protected]

0086-15601950612

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

Transcatheter Treatment of Pure Aortic Regurgitation With VitaFlow Liberty System: a Prospective, Multicenter Study

Acronym: TRAMPERS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2025
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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