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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
180 Fenglin Road
RECRUITING
Shanghai
Contact Information
Primary
Wenzhi Pan, MD
peden@sina.com
+86 13774475922
Time Frame
Start Date: 2025-07-30
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 232
Treatments
Experimental: Investigational Device
Transcatheter Aortic Valve Retrievable and Controllable Flex Delivery System (VitaFlow Liberty® Flex)
Active_comparator: Control Device
Transcatheter Aortic Valve and Delivery System (Self-Expanding Valve, Non-Controllable Flex Delivery System)
Sponsors
Collaborators: The First Affiliated Hospital of Nanchang University, Sichuan Provincial People's Hospital, The Second Affiliated Hospital of Dalian Medical University, Tang-Du Hospital, Guangdong Provincial People's Hospital, Renmin Hospital of Wuhan University, The Affiliated Hospital of Qingdao University, First Hospital of China Medical University, General Hospital of Ningxia Medical University, First Affiliated Hospital of Fujian Medical University, Second Affiliated Hospital of Nanchang University
Leads: Shanghai Zhongshan Hospital

This content was sourced from clinicaltrials.gov