VITALE trial
Research type
Research Study
Full title
A prospective, single arm clinical investigation evaluating safety and effectiveness/ performance of the Microport CardioFlow VitaFlow™ II-Transcatheter Aortic Valve System for the treatment of symptomatic severe aortic stenosis via transcatheter access in increased surgical risk patients
IRAS ID
258220
Contact name
Bernard Prendergast
Contact email
Sponsor organisation
Shanghai Microport CardioFlow Medtech Co., Ltd.
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 4 months, 30 days
Research summary
Research Summary
Prolonged average life expectancy has resulted in an aging population, aortic valve stenosis is one of the most common acquired valvular diseases in elderly patients (>75 years) in Western countries. Once symptoms occur, the prognosis is very poor; the average survival of patients that experience angina, syncopes (faints), or heart failure symptoms due to aortic valve stenosis is only 5, 3, and 2 years, respectively.
The current standard of care treatment for severe, symptomatic aortic valve stenosis is surgical aortic valve replacement (SAVR). However, one in three patients are rejected for SAVR, because of a too high operative risk.
In patients with high surgical risk, Transcatheter Aortic Valve Implantation (TAVI) has been shown to be feasible (procedural success rate of 90%). TAVI involves an aortic valve implantation without open heart surgery and does not require removal of the failed native aortic valve that is causing the problems.
This study will recruit 178 patients suffering from severe aortic stenosis in about 15 hospitals in up to 8 European countries experienced in performing TAVI procedure. Patients will be treated by implantation of a Microport CardioFlow VitaFlow™ Transcatheter Aortic Valve. After implantation of the bioprothesis the patients will be involved in the study for 5 years with follow-up in the hospital at 30 days, 6 months, 12 months, then annually until 5 years. At 30 days, 6 months and 12 months, ECGs will be recorded. During all follow-up visits Echocardiography (TTE) will be performed and Quality-of-Life and frailty questionnaires will be completed.
Lay summary of results
The VITALE study was performed in accordance with Declaration of Helsinki, REGULATION (EU) 2017/745-MDR, and ISO 14155. The CIP was designed in scientifically rigorous manner and proved by the EC committees. The early termination of the study was for administrative reasons and not involving any safety concern. The descriptive analysis of the 28 enrolled subjects during the 5 years follow-up showed that the safety profile of the VitaFlow Liberty was acceptable: the incidence of mortality, stroke, bleeding, AKI, new permanent pacemaker implantation was comparable to those reported in the literature. No un-anticipated events occurred, nor does the overall event occurrence rate raise any concerns. The implantation of the VitaFlow Liberty aortic valve significantly improve the valve function, heart function, and quality of life in the target population. In conclusion, the clinical benefits to the patients surpass the risks and demonstrate a positive benefit to risk profile for the VitaFlow Liberty TAV system.
REC name
London - Dulwich Research Ethics Committee
REC reference
19/LO/0166
Date of REC Opinion
8 Apr 2019
REC opinion
Further Information Favourable Opinion