Prospective, Multicenter, Randomized Controlled Clinical Study Evaluating the VitaFlow Liberty® Flex Transcatheter Aortic Valve Delivery System for the Treatment of Severe Aortic Stenosis Lesions

NCT07145463 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Zhongshan Hospital

Phase

Not applicable

Started

2025-07-30

Last updated

2025-08-28

Condition(s) studied

Aortic Valve Stenosis

Investigational drug(s) / intervention(s)

Transcatheter Aortic Valve Replacement

Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Implantation/Replacement (TAVI/TAVR) has gradually emerged as a new treatment option for patients with severe aortic stenosis who are ineligible for open-heart valve replacement or at high surgical risk.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. 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); 2. 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; 3. New York Heart Association (NYHA) functional class ≥II; 4. Voluntary participation in the study with signed informed consent. Exclusion Criteria: 1. Known allergy or intolerance to components of the investigational or control devices (e.g., nitinol) or contrast agents; 2. Contraindication or known allergy to anticoagulant or antiplatelet therapy, rendering the patient unable to tolerate such treatment; 3. Known active infective endocarditis or other active infections; 4. Known severe vascular disease that would preclude safe prosthetic valve implantation; 5. Ascending aorta width ≥55mm; 6. Pre-procedural imaging shows aortic root anatomy unsuitable for transcatheter aortic valve implantation (including aortic root calcification that may affect proper valve expansion); 7. Pre-procedural echocardiography shows intracardiac mass, left ventricular or left atrial thrombus, or vegetation; 8. Acute myocardial infarction within 30 days prior to procedure (defined as Q-wave MI or non-Q-wave MI); 9. Concomitant severe mitral or tricuspid regurgitation; 10. Concomitant cardiogenic shock or hemodynamic instability requiring inotropic support, mechanical ventilation, or mechanical cardiac assistance; 11. Concomitant severe left ventricular dysfunction (defined as left ventricular ejection fraction LVEF\<20%); 12. 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; 13. Female subjects known to be pregnant or breastfeeding; 14. 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.

Primary outcome measure(s)

the number of occurrences/total number of occurrences — 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

Trial sites (1)

Facility	City	Region	Status
180 Fenglin Road	Shanghai	Shanghai Municipality	Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07145463 on ClinicalTrials.gov ↗ ← All trials in China