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

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).