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TRanscAtheter TreatMent of PurE Aortic Regurgitation With VitaFlow Liberty System

Study acronym: TRAMPERS
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Feb 1, 2025 to Apr 29, 2025 · Interventions: SAVR+GDMT (Combination Product), TAVR+GDMT (Combination Product) to J-Valve+GDMT (Combination Product), VitaFlow+GDMT (Combination Product) · Eligibility criteria shortened, about 33 words · 3 morev2 Show 6 more changesShow less
    • Start date changed from estimate of Feb 1, 2025 to Apr 29, 2025
    • Interventions: SAVR+GDMT (Combination Product), TAVR+GDMT (Combination Product) to J-Valve+GDMT (Combination Product), VitaFlow+GDMT (Combination Product)
    • Eligibility criteria shortened, about 33 words
    • Study description shortened, about 81 words
    • Site details revised at 4 of 4 sites
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Ruijin Hospital
370 trials monitored
See 13 trials at risk
Heart Disease
2,136 trials monitored
See 109 trials at risk
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
Trial Details
NCT Number NCT06818084
Lead Sponsor Ruijin Hospital
Conditions AORTIC VALVE DISEASES, Aortic Regurgitation, Transcatheter Aortic Valve Replacement (TAVR)
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov