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ART Trial: Transcatheter J-VALVE Versus Surgery for Aortic Regurgitation Therapy

ConditionsAortic RegurgitationAortic Valve InsufficiencyAortic Insufficiency
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine

About this trial

The overall purpose of ART trial is to establish the Safety and Efficacy of the J-VALVE Transcatheter Aortic Valve Replacement Versus Surgical Aortic Valve Replacement in Patients with Grade≥3+ Native Aortic Regurgitation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1) Age ≥65 years；

2) a. Symptomatic patients with severe AR b. Asymptomatic patients with severe AR and evidence of LV function impairment (per current ESC / ACC guidelines) Any of the following perimeters

LVEF ≤55%

LVESD >50 mm

Disqualifiers

1. Confirmed moderate or less AR severity (Grade≤2+) by core laboratory evaluation

2. Moderate or severe aortic valve stenosis

3. Mixed with clinical relevant severe mitral or tricuspid disease that require valve intervention

4. Pre-existing mechanical or bioprosthetic valve in any position. (of note, mitral ring is not an exclusion)

Trial design

Design model

Parallel

Treatments tested in this trial

  • J-VALVE Transfemoral Aortic Valve system

    Device

    Transcatheter aortic valve replacement (TAVR) using J-VALVE Transfemoral Aortic Valve system

  • Commercially available surgical biological aortic valve replacement device

    Device

    Surgical aortic valve replacement（SAVR）using commercially available surgical biological aortic valve replacement device

Treatment groups

1,250 Participants
are divided into 2 treatment groups
Group A: Transcatheter aortic valve replacement (TAVR)Experimental treatment 1 intervention
Group B: Surgical aortic valve replacement（SAVR）Other 1 intervention

Trial outcomes

Primary outcomes

1

All-cause mortality

All-cause mortality at 12 months

Time frame
12 months
2

All stroke

Number of patients with stroke

Time frame
12 months
3

Unplanned cardiac rehospitalization

Number of patients who had unplanned cardiac rehospitalization

Time frame
12 months

Secondary outcomes

1

New-onset atrial fibrillation

Comparing the onset of atrial fibrillation in TAVR with SAVR

Time frame
30 days
2

Echocardiographic effective orifice area

Comparing echocardiographic effective orifice area in TAVR with SAVR

Time frame
30 days
3

Moderate or greater patient prosthesis mismatch as measured by echocardiography

Comparing moderate or greater patient prosthesis mismatched in TAVR with SAVR

Time frame
30 days
4

Cardiovascular rehospitalization

Comparing the number of cardiovascular rehospitalizations in TAVR with SAVR

Time frame
30 days

Other outcomes

1

Bleeding complications (life-threatening, disabling, or major)

Comparing bleeding complications in TAVR with SAVR

Time frame
30 days, 6 months and 1 year
2

Major adverse cardiovascular and cerebrovascular events (MACCE)

Freedom of major adverse cardiovascular and cerebrovascular events

Time frame
years 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
3

Mortality (all-cause & cardiovascular)

Comparing mortality (all-cause \& cardiovascular in TAVR with SAVR

Time frame
30 days,6 months and years 1, 5, 10
4

Stroke (disabling and nondisabling)

Comparing stroke (disabling and nondisabling) in TAVR with SAVR

Time frame
30days, 6 months and years 1, 5, 10

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, Zhejiang University, School of Medicine

Lead sponsor

Source ClinicalTrials.gov
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