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 | Recruiting DMC

• 1 other identifier: Flex-TAVR trial
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aortic Valve Stenosis

Keywords

TAVR; Steerable Delivery System; Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• the number of occurrences/total number of occurrences

  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

  Perioperative/Periprocedural"

Secondary Outcomes (12)

• 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

Study Arms (2)

Investigational Device

EXPERIMENTAL

Transcatheter Aortic Valve Retrievable and Controllable Flex Delivery System (VitaFlow Liberty® Flex)

Device: Transcatheter Aortic Valve Replacement

Control Device

ACTIVE COMPARATOR

Transcatheter Aortic Valve and Delivery System (Self-Expanding Valve, Non-Controllable Flex Delivery System)

Device: Transcatheter Aortic Valve Replacement

Interventions

Transcatheter Aortic Valve Replacement DEVICE

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.

Control Device; Investigational Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• First Hospital of China Medical University: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• First Affiliated Hospital of Fujian Medical University: collaborator
• Renmin Hospital of Wuhan University: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• The Second Affiliated Hospital of Dalian Medical University: collaborator
• Guangdong Provincial People's Hospital: collaborator
• General Hospital of Ningxia Medical University: collaborator
• Sichuan Provincial People's Hospital: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• Tang-Du Hospital: collaborator

Study Sites (1)

180 Fenglin Road

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (5)

• Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002 Dec 10;106(24):3006-8. doi: 10.1161/01.cir.0000047200.36165.b8.

  PMID: 12473543 BACKGROUND

• Grube E, Laborde JC, Gerckens U, Felderhoff T, Sauren B, Buellesfeld L, Mueller R, Menichelli M, Schmidt T, Zickmann B, Iversen S, Stone GW. Percutaneous implantation of the CoreValve self-expanding valve prosthesis in high-risk patients with aortic valve disease: the Siegburg first-in-man study. Circulation. 2006 Oct 10;114(15):1616-24. doi: 10.1161/CIRCULATIONAHA.106.639450. Epub 2006 Oct 2.

  PMID: 17015786 BACKGROUND

• Supino PG, Borer JS, Preibisz J, Bornstein A. The epidemiology of valvular heart disease: a growing public health problem. Heart Fail Clin. 2006 Oct;2(4):379-93. doi: 10.1016/j.hfc.2006.09.010. No abstract available.

  PMID: 17448426 RESULT

• Carabello BA, Paulus WJ. Aortic stenosis. Lancet. 2009 Mar 14;373(9667):956-66. doi: 10.1016/S0140-6736(09)60211-7. Epub 2009 Feb 21.

  PMID: 19232707 RESULT

• Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.

  PMID: 20961243 RESULT

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Wenzhi Pan, MD

  Fudan University

  STUDY CHAIR

Central Study Contacts

Wenzhi Pan, MD

CONTACT

+86 13774475922; peden@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, multicenter, randomized controlled study;Randomization will be performed at a 1:1 ratio using a central randomization system;All subjects will undergo clinical follow-up before discharge, at 30 days, and at 1 year post-procedure;An independent data management and statistical center, along with a clinical monitoring organization, will collect, organize, and statistically analyze all relevant clinical data;

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 28, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

CN (1)