TAVR vs. SAVR Study of VitaFlow Liberty® for Severe BAV Stenosis

NCT06597188 | Enrolling By Invitation DMC

• 1 other identifier: PROMIS-BAV-2024
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and effectiveness of the Transcatheter aortic valve and retrievable delivery system (VitaFlow Liberty®) for the treatment of severe bicuspid aortic valve (BAV) stenosis.

Conditions

Aortic Stenosis; Bicuspid Aortic Valve (BAV)

Keywords

Aortic stenosis; Bicuspid Aortic Valve (BAV); TAVR; SAVR

Outcome Measures

Primary Outcomes (1)

• Incidence of composite endpoint events (all-cause mortality, all strokes, and re-hospitalizations [surgery, valve or heart failure related re-hospitalizations])

  The composite endpoint event at 12 months postoperatively refers to all-cause mortality, all strokes, and re-hospitalizations related to procedure, valve or heart failure that occur within 12 months postoperatively.

  12 months postoperatively

Secondary Outcomes (20)

• Device success rate

  30 days postoperatively

• Prosthetic valve performance evaluation

  30 days, 6 months, 12 months, 2-5 years postoperatively

• New York Heart Association grading assessment of cardiac function

  Discharge, 30 days, 6 months, 12 months, 2-5 years postoperatively

• Quality of life assessment (Kansas City Cardiomyopathy Questionnaire score)

  30 days, 6 months, 12 months postoperatively

• All-cause mortality

  30 days, 6 months, 12 months, 2-5 years postoperatively

Study Arms (2)

TAVR group

EXPERIMENTAL

TAVR with the study device will be performed in the TAVR group

Device: VitaFlow Liberty

SAVR group

ACTIVE COMPARATOR

SAVR with a commercially available surgical bioprosthetic valve will be performed in the control group

Device: Commercially available surgical bioprosthetic valve

Interventions

VitaFlow Liberty DEVICE

All subjects randomized to the TAVR group will receive transcatheter aortic valve replacement (TAVR) with the study device of VitaFlow Liberty

TAVR group

Commercially available surgical bioprosthetic valve DEVICE

All subjects randomized to the SAVR group will receive surgical aortic valve replacement (SAVR) with the control device of a commercially available surgical bioprosthetic valve.

SAVR group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject aged ≤ 75 years;
• With symptomatic severe bicuspid aortic stenosis, defined as: peak flow velocity ≥ 4.0m/s, or mean trans-aortic pressure gradient ≥ 40mmHg, or aortic orifice area (AVA) ≤ 1.0cm2 (or AVA index ≤ 0.6cm2/m2) confirmed by echocardiography；
• New York Heart Association (NYHA) cardiac function classification ≥ Class II;
• With an intermediate or low risk of surgical procedures (STS score ≤8%) assessed by the local heart team;
• Voluntarily participate in this study and sign the informed consent form.

You may not qualify if:

• Known allergy or resistance to study device and control device components such as nitinol or contrast media;
• Known contraindication or allergy to anticoagulant or antiplatelet medications and inability to tolerate the anticoagulant or antiplatelet therapy;
• Known presence of active infective endocarditis or other active infection;
• Known presence of severe vascular disease that precludes safe implantation of the prosthetic valve;
• Ascending aorta width ≥50mm;
• Previous prosthetic valve implantation (mechanical or bioprosthetic) in any heart place;
• The aortic root anatomy not suitable for transcatheter aortic valve implantation confirmed by preoperative imaging (including aortic root calcification that influence the sufficient dilatation of the rposthetic valve);
• Intracardiac mass, left ventricular or left atrial thrombus, vegetations confirmed by preoperative echocardiography;
• Acute myocardial infarction (defined as Q-wave MI or non-Q-wave MI) within 30 days prior to surgery;
• Invasive therapeutic cardiac surgery within 30 days prior to surgery (except for temporary pacemaker or implantable cardioverter-defibrillator implantation);
• Clinically diagnosed stroke or TIA within 3 months prior to surgery;
• Gastrointestinal bleeding requiring hospitalization or transfusion therapy or other clinically significant bleeding or coagulation disorders within 3 months prior to surgery, which preclude the required antiplatelet therapy in the study;
• Comorbid with severe native coronary artery lesions that require revascularization therapy;
• Comorbid with severe mitral or tricuspid regurgitation;
• Comorbid with cardiogenic shock or hemodynamic instability requiring support from positive inotropic agents or mechanical ventilation or mechanical cardiac assistance;

Sponsors & Collaborators

• Shanghai MicroPort CardioFlow Medtech Co., Ltd.: lead
• West China Hospital: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• Zhejiang University: collaborator
• Qilu Hospital of Shandong University: collaborator
• People's Hospital of Xinjiang Uygur Autonomous Region: collaborator
• Provincial Hospital of fuzhou University: collaborator
• Yanan Hospital of Kunming City: collaborator

Study Sites (1)

WEST CHINA Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Bicuspid Aortic Valve Disease

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Mao Chen, Professor

  West China Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: September 8, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2032
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)