Health Trials

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

Locations

12
Beijing Anzhen Hospital Affiliated to Capital Medical University100000, BeijingBeijing Municipality, China
Fuwai Hospital, Chinese Academy of Medical Sciences100000, BeijingBeijing Municipality, China
Guangdong Provincial People's Hospital510000, GuangzhouGuangdong, China
Prince of Wales Hospital999077, Hong KongHong Kong, China

Sponsors and collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Source ClinicalTrials.gov