About this trial

This study is a prospective, multicenter, non-randomized controlled trial, planning to enroll 180 patients with pure native aortic regurgitation. On the basis of standardized medical therapy, patients will be assigned in a 1:1 ratio to undergo transfemoral transcatheter aortic valve replacement (TF-TAVR) . This prospective, multicenter trial aims to evaluate the safety and effectiveness of transfemoral TAVR using the VitaFlow™ self-expanding valve system compared to dedicated transcatheter devices in patients with PNAR.

The primary endpoint is a composite of all-cause mortality, disabling stroke, and rehospitalization for heart failure, myocardial Infarction, and requiring dialysis or valve reoperation at 12 months post-procedure.

Secondary endpoints include procedure-related complications, long-term clinical events, patient functional status and quality of life, bioprosthetic valve imaging follow-up, echocardiographic parameters, and treatment costs. All endpoint definitions conform to the Valve Academic Research Consortium-3 (VARC-3) criteria

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

VitaFlow+GDMT
Combination product
The patient will undergo transcatheter aortic valve replacement on the basis of guideline-directed medical therapy with The VitaFlow™ system. The VitaFlow™ system (MicroPort®, Shanghai, China) was a novel TAVR system, which incorporates high-radial force and a double layer polyethylene terephthalate (PET) skirt to optimize frame geometry and minimize the risks of paravalvular leak (PVL). The VitaFlow™ transcatheter aortic valve is made of a self-expanding nitinol frame and tri-leaflet bovine pericardial valve.
J-Valve+GDMT
Combination product
The patient will undergo transfemoral aortic valve replacement on the basis of guideline-directed medical therapy with The J-Valve system (Jie ChengMedical Technologies, Suzhou, China). The J-Valve system is a second-generation self-expand able device composed of a porcine bioprosthetic aortic valve and a transfemoral delivery sheath. The valve is supported by a self-expanding nitinol structure. The different valve sizes are 21, 23, 25, 27, 29 and 34 mm. Three U-shaped nitinol graspers were designed to surround the valve.

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: VitaFlowExperimental treatment 1 intervention

Group B: J-ValveActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical worsening

The primary endpoint is a composite of all-cause mortality, disabling stroke, and rehospitalization for heart failure, myocardial Infarction, and requiring dialysis or valve reoperation at 12 months post-procedure.

Time frame

12 months

Secondary outcomes

1

Rate of procedural complications

The rate of any aortic dissection, annular rupture, coronary artery occlusion, vascular complications, permanent pacemaker implantation, reoperation of heart valve.

Time frame

12 months

2

6-minute walk distance

This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.

Time frame

12 months

3

New York Heart Association (NYHA) functional class

Classification of function capacity of the NYHA.

Time frame

12 months

4

Rate of hypoattenuated leaflet thickening

The rate of hypoattenuated leaflet thickening. Hypoattenuated leaflet thickening（HALT）defined by VARC-3

Time frame

12 months

Other outcomes

1

Left ventricular ejection fraction (Simpson's method)

Transthoracic echocardiography measurement of left ventricular ejection fraction (Simpson's method). Unit: %

Time frame

12 months

2

Left ventricular end-diastolic volume index

Transthoracic echocardiography measurement left ventricular end-diastolic volume index (LVEDVi). Unit: milliliters per square meter (mL/m²)

Time frame

12 months

3

Left ventricular end-systolic volume index

Transthoracic echocardiography measurements of left ventricular end-systolic volume index (LVESVi). Unit: milliliters per square meter (mL/m²)

Time frame

12 months

4

Left ventricular end-diastolic diameter

Transthoracic echocardiography measurements of left ventricular end-diastolic diameter (LVEDd). Unit: millimeters

Time frame

12 months

TRanscAtheter TreatMent of PurE Aortic Regurgitation With VitaFlow Liberty System

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts