TReanscAtheter TreatMent of PurE Aortic Regurgitation with VitaFlow Liberty System

Launched by RUIJIN HOSPITAL · Feb 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for patients with severe aortic regurgitation, a condition where the aortic valve doesn’t close properly, allowing blood to flow backward into the heart. The trial will enroll 120 patients who are experiencing symptoms related to this condition. Participants will be assigned to receive either a less invasive procedure called transcatheter aortic valve replacement (TAVR) or the traditional surgical approach, known as surgical aortic valve replacement (SAVR). The main goal of the study is to see how these treatments affect important health outcomes, such as overall survival, heart-related complications, and quality of life one year after the procedure.

To be eligible for this trial, participants need to be at least 60 years old and have moderate to severe aortic regurgitation, either with symptoms or certain heart function measurements. They should also be in good enough health to undergo either TAVR or SAVR. During the trial, participants will receive follow-up care to monitor their health and recovery. It’s important to note that the trial is not yet recruiting participants, and those interested will need to provide informed consent and be willing to meet the study requirements.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 60 years;
• • Symptomatic moderate-to-severe or greater isolated aortic regurgitation;
• * Asymptomatic moderate-to-severe or greater isolated aortic regurgitation meeting any one of the following criteria:
• • LVEF ≤ 55% (measured by biplane Simpson's method) LVESd \> 50 mm or LVESDi \> 25 mm/mm² Progressive left ventricular enlargement;
• • The patient's anatomy is deemed suitable for transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) by the investigator;
• • The patient or their legal representative has been informed of the nature of this study and agrees to all terms of participation, has signed the informed consent form approved by the ethics committee, agrees to undergo the surgical treatment plan and follow-up requirements, and is able to complete the follow-up and required examinations.
• Exclusion Criteria:
• • Incomplete coronary revascularization;
• • Receiving guideline-recommended medical therapy at the maximum tolerated dose for \<30 days;
• • Life expectancy \< 1 year;
• • LVEF \< 45%;
• • eGFR \< 30 mL/min/1.73m²;
• • Allergy to relevant medications or contraindications to their use (e.g., aspirin, clopidogrel, warfarin, contrast agents, etc.);
• • Inability to undergo contrast-enhanced CT examination for any reason;
• • Presence of moderate-to-severe or greater other valvular heart diseases;
• • Poor patient compliance, unable to complete follow-up as required;
• • Other circumstances deemed by the investigator that should lead to exclusion.