Transcatheter treatment of pure aortic regurgitation with the VitaFlowTM Liberty system: design & rationale of the prospective, multicenter, non-randomized TRAMPERS study.
Jiwei Yu, Ni Zhu, Li Zhu...
https://pubmed.ncbi.nlm.nih.gov/41739727Actively Recruiting
Phase 4
Age: 60Years +
All Genders
ID06818084
Transcatheter Treatment of Pure Aortic Regurgitation With VitaFlow Liberty System: a Prospective, Multicenter Study
Led by Ruijin Hospital · Updated on 2026-01-30
120
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of transfemoral transcatheter aortic valve replacement (TF-TAVR) using the VitaFlow™ self-expanding valve system compared to other dedicated transcatheter devices in patients with pure native aortic regurgitation. The study will enroll 180 patients with symptomatic or asymptomatic moderate-to-severe isolated aortic regurgitation who are 60 years or older, assessing major clinical outcomes over 12 months. The trial follows Valve Academic Research Consortium-3 (VARC-3) criteria for endpoint definitions. Participants will be assigned in a 1:1 ratio to receive TF-TAVR using either the VitaFlow™ valve system or the J-Valve system, both combined with guideline-directed medical therapy. The VitaFlow™ system features a self-expanding nitinol frame with a bovine pericardial valve and a double-layer skirt designed to reduce leaks. The J-Valve system includes a porcine bioprosthetic valve with nitinol graspers for positioning. The study compares clinical events, valve imaging, functional status, quality of life, and costs between these two interventions. During the study, participants will have assessments at baseline, 6 months, and 12 months, including echocardiography to evaluate heart function and valve performance, computed tomography angiography to assess valve leaflet motion, and questionnaires measuring heart failure symptoms, social support, physical activity, and walking ability. Researchers will monitor for complications, hospitalizations, mortality, and treatment expenses over the 12-month period to evaluate the overall clinical impact and safety of the procedures.
CONDITIONS
Brief Title
TRanscAtheter TreatMent of PurE Aortic Regurgitation With VitaFlow Liberty System
Who Can Participate
Age: 60Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 60 years or older
- Symptomatic moderate-to-severe or greater isolated aortic regurgitation
- Asymptomatic moderate-to-severe or greater isolated aortic regurgitation with at least one of: LVEF 55% or lower; LVESD > 50 mm; LVESDi > 22 mm/m²; LVESVi > 45 mL/m²
- Anatomical suitability for TAVR as assessed by heart team
- Willingness and ability to provide informed consent and comply with follow-up assessments
You will not qualify if you...
- Incomplete coronary revascularization
- Less than 30 days of guideline-directed medical therapy at maximum tolerated doses
- Life expectancy less than 1 year
- LVEF less than 45%
- eGFR less than 30 mL/min/1.73m²
- Known allergy or contraindication to required medications or contrast media
- Any condition preventing contrast-enhanced CT
- Concurrent moderate-to-severe or severe valvular heart disease other than aortic regurgitation
- Poor compliance or inability to complete follow-up
- Any other condition making the patient unsuitable for the study per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Procedure day plus initial hospital stay
Participants undergo transcatheter aortic valve replacement (TAVR) using either the VitaFlow™ or the J-Valve system on the basis of guideline-directed medical therapy.
1 procedure visit and approximately 6 post-operative visits
Follow-up
Duration - 12 months
Participants are monitored for safety, valve function, heart function, quality of life, and clinical outcomes up to 12 months after the TAVR procedure.
Visits at 6 and 12 months after treatment
Trial Site Locations
Total: 4 locations
1
Ruijin hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
2
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
3
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
4
Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
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Research Team
Z
Zhengbin Zhu, MD. PhD.
J
Jiwei Yu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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