Condition: AORTIC VALVE DISEASES · Aortic Regurgitation · Transcatheter Aortic Valve Replacement (TAVR) · Sponsor: Ruijin Hospital
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
This description comes directly from the study's public registry record.
Zhengbin Zhu, MD. PhD. · 0086-15601950612 · zzb11561@rjh.com.cn
Jiwei Yu, MD · 0086-13761292857 · yjw12506@rjh.com.cn
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| Ruijin hospital, Shanghai JiaoTong University School of Medicine | Shanghai, Shanghai Municipality, China | Recruiting |
| Shanghai Chest Hospital | Shanghai, Shanghai Municipality, China | Recruiting |
| Zhongshan Hospital, Fudan University | Shanghai, Shanghai Municipality, China | Recruiting |
| Changhai Hospital | Shanghai, Shanghai Municipality, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06818084