Using a steerable VitaFlow Liberty Flex catheter to deliver transcatheter aortic valves in patients with difficult aortic anatomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, randomized 1:1 trial comparing the investigational steerable VitaFlow Liberty Flex delivery system with the non-steerable VitaFlow Liberty system in patients with severe aortic stenosis and difficult anatomy. Approximately 15 hospitals in China will enroll eligible patients and randomize them to receive TAVR with either the steerable or control delivery catheter. The primary endpoint is a composite measured before hospital discharge (permanent pacemaker implantation, valve-in-valve implantation, or moderate-to-severe paravalvular leak), with follow-up at discharge, 30 days, and 1 year. The trial is open-label and uses centralized randomization to reflect real-world procedural practice.

Why it matters

Who can join: the full rules

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.

Where it's running

• 180 Fenglin Road
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Wenzhi Pan, MD
• Email: peden@sina.com
• Phone: +86 13774475922

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Transcatheter Aortic Valve Replacement Registry for Outcomes and Quality Monitoring

  This registry collects information from hospitals about patients undergoing TAVR to see how care and outcomes compare to guidelines and nationwide data.

  Recruiting American College of Cardiology · Washington D.C., District of Columbia · NCT07908355

• Vericiguat to slow calcific aortic valve narrowing

  This trial tests whether vericiguat can slow the progression of mild-to-moderate calcific aortic valve stenosis compared with placebo.

  Recruiting Phase 2 West China Hospital · Chengdu, Sichuan · NCT07715279

• CHATEAU Registry: Real-world outcomes after TAVR

  This registry collects real-world data from adults who had TAVR between 2021 and 2025 to see how they do over time and how valve performance holds up.

  Recruiting Eunpyeong St. Mary's Hospital · Seoul · NCT07709858

• Impact of TAVR on kidney function in people with aortic valve disease

  This registry tests how trans-catheter aortic valve implantation affects kidney function and the risk of kidney injury in adults with aortic stenosis.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma, RM · NCT07626710

• Hydra THV Transfemoral Valve Implantation in Severe Aortic Stenosis

  This registry tests how safely and effectively the Hydra THV works when implanted through the femoral artery in adults with severe symptomatic aortic stenosis.

  Recruiting at 8 sites Fundación EPIC · Aravaca and 7 other locations · NCT07566624

• How the type of sedation affects recovery after TAVR

  This study will test whether three common sedation approaches (propofol, dexmedetomidine, or midazolam with fentanyl) change how people recover on the first day after transfemoral TAVR.

  Recruiting Phase 4 Endeavor Health · Glenview, Illinois · NCT07556523

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.