Clinical trial NCT06818084: TReanscAtheter TreatMent of PurE Aortic Regurgitation with VitaFlow Liberty System
Official title: Treanscatheter Treatment of Pure Aortic Regurgitation with VitaFlow Liberty System: a Prospective, Multicenter Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: AORTIC VALVE DISEASES
Aortic Regurgitation
Transcatheter Aortic Valve Replacement (TAVR)
Keywords: pure aortic regurgitation
Transcatheter aortic valve replacement (TAVR)
hypoattenuated leaflet thickening
reduced leaflet motion
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Clinical worsening
timeFrame: 12 months
Secondary outcomes:
measure: Rate of procedural complications
timeFrame: 12 months
measure: 6-minute walk distance
timeFrame: 12 months
measure: New York Heart Association (NYHA) functional class
timeFrame: 12 months
measure: Rate of hypoattenuated leaflet thickening
timeFrame: 12 months
measure: Rate of reduced leaflet motion
timeFrame: 12 months
measure: Rate of Stroke
timeFrame: 12 months
measure: Mortality
timeFrame: 12 months
measure: Rate of bleeding complications
timeFrame: 12 months
measure: Rate of prothetic valve dysfunction
timeFrame: 12 months
measure: Rate of rehospitalization
timeFrame: 12 months
measure: Quality of life assessment (Minnesota Living with Heart Failure Questionnaire, MLHFQ)
timeFrame: 12 months
measure: Quality of life assessment (social supporting raing scal, SSRS)
timeFrame: 12 months
measure: Quality of life assessment (International Physical Activity Questionnaire, IPAQ)
timeFrame: 12 months
measure: Treatment costs
timeFrame: 12 months
Other outcomes:
measure: Left ventricular ejection fraction (Simpson's method)
timeFrame: 12 months
measure: Left ventricular end-diastolic volume index
timeFrame: 12 months
measure: Left ventricular end-systolic volume index
timeFrame: 12 months
measure: Left ventricular end-diastolic diameter
timeFrame: 12 months
measure: Left ventricular end-systolic diameter
timeFrame: 12 months
measure: Aortic valve orifice area
timeFrame: 12 months
measure: Transvalvular pressure gradient of aortic valve
timeFrame: 12 months
Locations:
city: Shanghai
country: China
facility: Ruijin hospital, Shanghai JiaoTong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: ZhengBin Zhu, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References: