A Prospective, Multicenter, Randomized Controlled Clinical Study Evaluating the VitaFlow Liberty® Flex Transcatheter Aortic Valve Retrievable and Steerable Delivery System for the Treatment of Severe Aortic Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- the number of occurrences/total number of occurrences
研究概览
简要总结
This is a prospective, multicenter, randomized controlled clinical study designed to evaluate the real-world performance of the VitaFlow Liberty® Flex Transcatheter Aortic Valve Retrievable and Steerable Delivery System (Investigational Device) for treating severe aortic stenosis (AS) in challenging anatomies. The study will compare it against the VitaFlow Liberty® Retrievable Delivery System (Control Device), which lacks steerability.
Key Study Elements:
Objective: The primary objective is to assess the device's performance using the incidence of a composite endpoint before hospital discharge. This endpoint includes permanent pacemaker implantation (PPI), valve-in-valve (ViV) implantation, or moderate-to-severe paravalvular leakage (PVL).
Design: A prospective, multicenter RCT with 1:1 randomization (Experimental: VitaFlow Liberty® Flex vs. Control: VitaFlow Liberty®). Approximately 15 sites in China will participate. Subjects undergo follow-up at discharge, 30 days, and 1 year post-procedure. An independent data center handles management and analysis.
Population: Patients with severe AS (echo confirmed: peak velocity ≥4.0 m/s, mean gradient ≥40 mmHg, or AVA ≤1.0 cm²/AVAi ≤0.6 cm²/m²) AND preoperative CTA showing a challenging aortic-left ventricular angle >60°. NYHA class ≥II is required.
Devices:
Investigational: VitaFlow Liberty® Flex (Retrievable & Steerable Delivery System - Models DSRS21/24/27/30/A series; Loading Tools LT-S series).
Control: VitaFlow Liberty® (Retrievable Delivery System - Models DSR21/24/27/30; Loading Tools LT series).
Endpoints:
Primary: Composite of PPI, ViV, or moderate-to-severe PVL before discharge.
Secondary: Include individual components of the primary endpoint (ViV, PVL) immediately post-procedure, procedural success (VARC-3), technical assistance rates, valve retrievals, implantation depth, arch/valve crossing performance, valve hemodynamics (gradient, area, leak, LVEF), NYHA class, Major Adverse Cardiac and Cerebrovascular Events (MACCE - all-cause death, MI, stroke, reoperation), major vascular complications (at discharge/30 days).
Key Inclusion: Severe AS, challenging anatomy (aortic-LV angle >60°), NYHA ≥II, informed consent.
Key Exclusions: Device/contrast allergies, anticoagulant intolerance, active infection, severe vascular disease prohibiting access, ascending aorta ≥55mm, unsuitable aortic root anatomy, intracardiac mass/thrombus, recent MI (<30 days), severe concomitant mitral/tricuspid regurgitation, cardiogenic shock, severe LV dysfunction (LVEF<20%), hematologic abnormalities, pregnancy/breastfeeding, participation in other device trials.
Visits: Screening (≤30d pre-op), Procedure (intra-op to 24h post-op), Discharge (≤7d post-op), 30d Follow-up (±7d), 12m Telephone FU (±1m).
Sample Size: Planned enrollment of 232 subjects (116 per group), calculated for superiority testing. Based on an expected composite endpoint rate of 21% for the Flex system vs. a historical rate of 38% for non-steerable systems (Superiority margin Δ1=0%, one-sided α=2.5%, Power=80%, accounting for 5% dropout).
Purpose: This study aims to demonstrate the superiority of the retrievable and steerable VitaFlow Liberty® Flex delivery system in reducing the composite rate of key adverse events (PPI, ViV, significant PVL) at discharge compared to the non-steerable system, specifically in patients with severe AS and anatomically challenging aortic-left ventricular angles.
详细描述
A Prospective, Multicenter, Randomized Controlled Clinical Trial Evaluating the VitaFlow Liberty® Flex Transcatheter Aortic Valve Retrievable and Steerable Delivery System for Severe Aortic Stenosis in Challenging Anatomies
- Study Rationale and Objective Severe aortic stenosis (AS) carries significant morbidity and mortality when untreated. Transcatheter aortic valve replacement (TAVR) has emerged as a standard therapy, yet complex aortic anatomies - particularly steep aortic-left ventricular (LV) angles - present technical challenges during valve delivery, potentially leading to suboptimal deployment, paravalvular leak (PVL), conduction disturbances requiring permanent pacemaker implantation (PPI), or valve-in-valve (ViV) placement. The VitaFlow Liberty® Flex Delivery System addresses this with its retrievable and steerable catheter technology designed for enhanced navigability. This prospective, multicenter, randomized controlled trial (RCT) aims to evaluate the real-world superiority of the investigational VitaFlow Liberty® Flex System versus the non-steerable VitaFlow Liberty® System in patients with severe AS and challenging anatomies (aortic-LV angle >60°). The primary objective is to compare the incidence of a composite safety endpoint (PPI, ViV implantation, or moderate-to-severe PVL) before hospital discharge.
- Study Design
Type: Prospective, multicenter, open-label, 1:1 randomized controlled superiority trial
Randomization: Centralized electronic system
Blinding: Unblinded (procedural nature precludes blinding)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of severe aortic stenosis, defined as: echocardiographically confirmed peak aortic valve velocity ≥4.0 m/s, or mean aortic valve gradient ≥40 mmHg, or aortic valve area (AVA) ≤1.0 cm2 (or AVA index ≤0.6 cm2/m2);
- •Preoperative cardiac and great vessel CT angiography (CTA) with 3D reconstruction demonstrating an aortic-left ventricular angle >60°, indicating potential challenges for arch crossing and valve crossing;
- •New York Heart Association (NYHA) functional class ≥II;
- •Voluntary participation in the study with signed informed consent.
排除标准
- •Known allergy or intolerance to components of the investigational or control devices (e.g., nitinol) or contrast agents;
- •Contraindication or known allergy to anticoagulant or antiplatelet therapy, rendering the patient unable to tolerate such treatment;
- •Known active infective endocarditis or other active infections;
- •Known severe vascular disease that would preclude safe prosthetic valve implantation;
- •Ascending aorta width ≥55mm;
- •Pre-procedural imaging shows aortic root anatomy unsuitable for transcatheter aortic valve implantation (including aortic root calcification that may affect proper valve expansion);
- •Pre-procedural echocardiography shows intracardiac mass, left ventricular or left atrial thrombus, or vegetation;
- •Acute myocardial infarction within 30 days prior to procedure (defined as Q-wave MI or non-Q-wave MI);
- •Concomitant severe mitral or tricuspid regurgitation;
- •Concomitant cardiogenic shock or hemodynamic instability requiring inotropic support, mechanical ventilation, or mechanical cardiac assistance;
- •Concomitant severe left ventricular dysfunction (defined as left ventricular ejection fraction LVEF<20%);
- •Concomitant hematologic abnormalities defined as leukopenia (WBC count <3×109/L), thrombocytopenia (platelet count <30×109/L), history of bleeding diathesis or coagulopathy, or hypercoagulable state;
- •Female subjects known to be pregnant or breastfeeding;
- •Subjects currently participating in or planning to participate in other drug or device clinical studies within 12 months postoperatively; Any other condition that the investigator or heart team deems may hinder the subject's safe participation in the study.
结局指标
主要结局
the number of occurrences/total number of occurrences
时间窗: Perioperative/Periprocedural"
Incidence of composite endpoint events before discharge (permanent pacemaker implantation, valve-in-valve, or moderate-to-severe paravalvular leak) calculated as number of occurrences/total number of occurrences
次要结局
- Incidence of valve-in-valve(Perioperative/Periprocedural)
- Incidence of Moderate-to-severe paravalvular leak(Perioperative/Periprocedural)
- Incidence of Other technical assistance crossing rate(Perioperative/Periprocedural)
- Incidence of valve retrievals(Perioperative/Periprocedural)
- Valve implantation depth calculated as Intraoperative images(Perioperative/Periprocedural)
- Incidence of Permanent Pacemaker Implantation(Perioperative/Periprocedural, 30 days,)
- Arch Crossing and Valve Crossing Performance calculated as assessment scale(Perioperative/Periprocedural)
- Number of participants with Valve Performance Evaluation(Perioperative/Periprocedural, 30 days,)
- NYHA Functional Class Assessment NYHA classification(Perioperative/Periprocedural, 30 days)
- Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE)(Perioperative/Periprocedural, 30 days,)
- Incidence of Major Vascular Complications(Perioperative/Periprocedural, 30 days)
- Procedural Success Rate (VARC-3 Definition)(Perioperative/Periprocedural)