Health Trials

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, School of Medicine, Zhejiang University

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

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

Treatments tested in this trial

  • J-VALVE Transfemoral Aortic Valve system
  • Commercially available surgical biological aortic valve replacement device

Treatment groups

1,250 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Source ClinicalTrials.gov