TRanscAtheter TreatMent of PurE Aortic Regurgitation With VitaFlow Liberty System

Official title

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

Overview

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.

Interventions

• 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 pe
• 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 desi

Primary outcome measures

• Clinical worsening [Time frame: 12 months]

Secondary outcome measures (12)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 4 centers

• Ruijin hospital, Shanghai JiaoTong University School of Medicine — Shanghai
• Shanghai Chest Hospital — Shanghai
• Zhongshan Hospital, Fudan University — Shanghai
• Changhai Hospital — Shanghai

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. PMID 41739727

Identifiers

NCT: NCT06818084 · 24SF1904800 · 24SF1904800

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗