TRanscAtheter TreatMent of PurE Aortic Regurgitation With VitaFlow Liberty System

NCT06818084 | Recruiting Phase 4

• 1 other identifier: 24SF1904800
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief 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) . 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

Conditions

Aortic Regurgitation; Transcatheter Aortic Valve Replacement (TAVR); AORTIC VALVE DISEASES

Keywords

pure aortic regurgitation; Transcatheter aortic valve replacement (TAVR); hypoattenuated leaflet thickening; reduced leaflet motion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Rate of procedural complications

  12 months

• 6-minute walk distance

  12 months

• New York Heart Association (NYHA) functional class

  12 months

• Rate of hypoattenuated leaflet thickening

  12 months

• Rate of reduced leaflet motion

  12 months

Other Outcomes (7)

• Left ventricular ejection fraction (Simpson's method)

  12 months

• Left ventricular end-diastolic volume index

  12 months

• Left ventricular end-systolic volume index

  12 months

Study Arms (2)

VitaFlow

EXPERIMENTAL

Patients who meet the inclusion and exclusion criteria will undergo TAVR using the VitaFlow™ self-expanding valve system.

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.

Combination Product: J-Valve+GDMT

Interventions

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.

VitaFlow

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.

J-Valve

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (4)

Ruijin hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Aortic Valve Disease; Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• ZhengBin Zhu, MD. PhD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhengbin Zhu, MD. PhD.

CONTACT

0086-15601950612; zzb11561@rjh.com.cn

Jiwei Yu, MD

CONTACT

0086-13761292857; yjw12506@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 25, 2025
• First Posted: February 10, 2025
• Study Start: April 29, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: January 30, 2026

Record last verified: 2025-12

Locations

CN (4)