TReanscAtheter TreatMent of PurE Aortic Regurgitation with VitaFlow Liberty System

Phase 4

Not yet recruiting

• Conditions: AORTIC VALVE DISEASES; Aortic Regurgitation; Transcatheter Aortic Valve Replacement (TAVR)

• Registration Number: NCT06818084
• Lead Sponsor: Ruijin Hospital

Brief Summary

This study is a prospective, multicenter, non-randomized controlled trial, planning to enroll 120 patients with pure native aortic regurgitation. On the basis of standardized medical therapy, patients will be assigned in a 3:1 ratio to undergo transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). The primary endpoint is a composite of all-cause mortality, cardiovascular mortality, stroke, rehospitalization for heart failure, and renal failure requiring dialysis treatment at 12 months after surgery. Additionally, the study will analyze issues related to follow-up imaging findings, postoperative quality of life and health economics in patients.

Detailed Description

This study is a prospective, multicenter, non-randomized controlled trial, enrolling 120 patients with pure native aortic regurgitation. On the basis of standardized medical therapy, patients will be assigned in a 3:1 ratio to undergo transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Patients will undergo echocardiography at 6 months after surgery and echocardiography and coronary computed tomography angiography (CTA) at 12 months after TAVR procedure or surgery. Blood plasma and serum samples will be collected from all patients.

The purpose of this study is to evaluate the safety and efficacy of TAVR for the treatment of isolated aortic regurgitation. The study will compare all-cause mortality, cardiovascular mortality, stroke, rehospitalization for heart failure, and renal failure requiring dialysis treatment at 12 months after surgery. Additionally, the study will assess the incidence of hypoattenuated leaflet thickening (HALT) and reduced leaflet motion (RLM) via CTA, as well as the aortic valve root-prosthesis coaxiality. Changes and differences between groups in the following parameters will be evaluated using transthoracic echocardiography at 6 and 12 months after enrollment: left ventricular ejection fraction (Simpson method), left ventricular end-diastolic volume index (LVEDVi), left ventricular end-systolic volume index (LVESVi), left ventricular end-diastolic diameter (LVEDd), left ventricular end-systolic diameter (LVESd), estimated aortic valve orifice area, valvular regurgitation, and transvalvular pressure gradient compared with baseline. The study will also compare changes and differences between groups in the Minnesota Living with Heart Failure Questionnaire, Social Support Rating Scale (SSRS), International Physical Activity Questionnaire (IPAQ), and 6-minute walk test (6MWT) at 6 and 12 months after enrollment compared with baseline. Furthermore, the study will compare surgical costs, potential complication costs, and disease-related costs between the two groups.

Study Timeline

• Study First Submitted: 2025-01-25
• Status Verified: 2025-02
• Study Start: 2025-02-01
• Study First Submitted QC: 2025-02-05
• Last Update Submitted: 2025-02-05
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Primary Completion: 2027-11-30
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical worsening	12 months	The composite endpoint of the rate all-cause death, cardiovascular death, stroke, rehospitalization for heart failure, and renal failure requiring dialysis treatment.

Secondary Outcome Measures

Name	Time	Method
Rate of prothetic valve dysfunction	12 months	The rate of any prothetic aortic valve stenosis, prothesis-patient mismatch, prosthetic aortic valve regurgitation
Quality of life assessment (social supporting raing scal, SSRS)	12 months	Total score of social supporting raing scal (SSRS). The total score ranges from 0 to 40, with higher scores indicating a higher level of social support.
Quality of life assessment (International Physical Activity Questionnaire, IPAQ)	12 months	Total score of International Physical Activity Questionnaire (IPAQ). The total score is calculated by multiplying the frequency and duration of each activity by its respective MET value, and then summing these products. The result is a measure of the total energy expenditure from physical activity in MET-minutes per week.The total score can be used to classify individuals into different physical activity levels, such as low, moderate, or high.
Treatment costs	12 months	Including surgical costs, potential complications costs, and disease-related costs
New York Heart Association (NYHA) functional class	12 months	Classification of function capacity of the NYHA.
6-minute walk distance	12 months	This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.
Rate of hypoattenuated leaflet thickening	12 months	The rate of hypoattenuated leaflet thickening. Hypoattenuated leaflet thickening（HALT）defined by VARC-3
Rate of reduced leaflet motion	12 months	Rate of reduced leaflet motion. Reduced leaflet motion（RLM）defined by VARC-3.
Mortality	12 months	All-cause, cardiovascular, and non-cardiovascular mortality
Rate of bleeding complications	12 months	Rate of bleeding complications. The original VARC definitions with BARC classifications
Rate of rehospitalization	12 months	The rate of rehospitalization due to valve-related symptoms or worsening congestive heart failure.
Rate of procedural complications	12 months	The rate of any aortic dissection, annular rupture, coronary artery occlusion, vascular complications, permanent pacemaker implantation, reoperation of heart valve.
Rate of Stroke	12 months	Stroke is defined as an acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction.
Quality of life assessment (Minnesota Living with Heart Failure Questionnaire, MLHFQ)	12 months	Total score of Minnesota Living with Heart Failure Questionnaire (MLHFQ). The total score ranges from 0 to 105, with higher scores indicating a greater impact of heart failure on quality of life and worse outcome..

Trial Locations

Locations (4)

Ruijin hospital, Shanghai JiaoTong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China