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New treatment option for Aortic Valve Stenosis
Official title Prospective, Multicenter, Randomized Controlled Clinical Study Evaluating the VitaFlow Liberty® Flex Transcatheter Aortic Valve Delivery System for the Treatment of Severe Aortic Stenosis Lesions
ClinicalTrials.gov ID: NCT07145463
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of severe aortic stenosis, defined as: echocardiographically confirmed peak aortic valve velocity ≥4.0 m/s, or mean aortic valve gradient...
- Preoperative cardiac and great vessel CT angiography (CTA) with 3D reconstruction demonstrating an aortic-left ventricular angle \>60°, indicating...
- New York Heart Association (NYHA) functional class ≥II;
- Voluntary participation in the study with signed informed consent.
You likely can't join 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...
See the full eligibility criteria
- 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...
- 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.
- 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 people known to be pregnant or breastfeeding;
- people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.