What does this research mean for the field?

Transfemoral TAVR using the VitaFlow™ Liberty system is safe and effective for treating severe pure native aortic regurgitation in patients who are ineligible for surgical aortic valve replacement. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

Evaluate the safety and effectiveness of transfemoral TAVR with the VitaFlow Liberty system in severe pure native aortic regurgitation.

February 28, 2026

Transcatheter treatment of pure aortic regurgitation with the VitaFlowTM Liberty system: design & rationale of the prospective, multicenter, non-randomized TRAMPERS study.

Resultado clave

The TRAMPERS trial is designed to assess safety and effectiveness of VitaFlow™ Liberty versus J-Valve for transfemoral TAVR in severe pure native aortic regurgitation patients.

Puntos clave

Evaluate the safety and effectiveness of transfemoral TAVR with the VitaFlow Liberty system in severe pure native aortic regurgitation.
Multicenter, open-label clinical trial design
180 patients with severe aortic regurgitation recruited
Patients allocated 1:1 to VitaFlow or J-Valve groups
Primary endpoint assesses a composite of mortality, stroke, and rehospitalization at 12 months
Endpoints adjudicated per VARC-3 criteria.
Primary endpoint focuses on non-inferiority of VitaFlow compared to J-Valve
Secondary endpoints investigate procedural complications and health outcomes
Overall aim is to provide robust evidence for transcatheter treatment options.

PICO estructurado

Does transfemoral TAVR using the VitaFlow Liberty self-expanding valve system provide non-inferior outcomes compared to the J-Valve system in patients with severe pure native aortic regurgitation?

Población

180 patients with severe pure native aortic regurgitation (PNAR) evaluated by a heart team across four centers in China.

Intervención

Transfemoral transcatheter aortic valve replacement (TAVR) using the VitaFlow Liberty self-expanding valve system (n=90).

Comparador

Transfemoral transcatheter aortic valve replacement (TAVR) using the J-Valve system (n=90).

Resultado

Composite of all-cause mortality, disabling stroke and rehospitalization for heart failure at 12 months post-procedure.composite

The TRAMPERS study is designed to provide prospective comparative evidence on the safety and effectiveness of the VitaFlow Liberty system versus the J-Valve system for the transcatheter treatment of severe pure native aortic regurgitation.

Resultado numérico

Tasa de eventos absoluta: 0% vs 0%

Resumen

Severe pure native aortic regurgitation (PNAR), if untreated, carries a high mortality rate. Many patients are ineligible for surgical aortic valve replacement (SAVR) due to high risk. While transcatheter aortic valve replacement (TAVR) is an alternative, its application in PNAR is challenged by anatomical factors like the absence of calcification for anchoring. Dedicated transcatheter devices are not widely available, leading to the off-label use of self-expanding valves, though robust comparative evidence is lacking. The TRAMPERS trial is a prospective, multicenter, controlled, open-label clinical trial that aims to evaluate the safety and effectiveness of transfemoral TAVR using the VitaFlow™ Liberty self-expanding valve system compared to the J-Valve system in patients with severe PNAR. A total of 180 patients with severe PNAR will be enrolled across four centers in China and evaluated by a heart team. Patients will be allocated in a 1:1 ratio to the VitaFlow™ group (n = 90) or the J-Valve control group (n = 90). The primary endpoint is a composite of all-cause mortality, disabling stroke and rehospitalization for heart failure at 12 months post-procedure, assessed for non-inferiority. Secondary endpoints include procedural complications, clinical events, health status and cost-effectiveness. All endpoints are adjudicated according to VARC-3 criteria.Clinical Trial Registration:NCT06818084 (ClinicalTrials.gov).

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