J-Valve to Treat Aortic Regurgitation Via Transcatheter Therapy

JC Medical, Inc., an affiliate of Edwards Lifesciences LLC

Summary

The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed aortic valve disease, who are judged by a multi-disciplinary heart team to be at high risk for open surgical aortic valve replacement (SAVR). A Cardiac Magnetic Resonance (CMR) sub-study will examine if intervention for AR translates to improved ventricular remodeling, the impact of LV remodeling on clinical outcomes and quality of life, as well as volumetric and myocardial differences between genders.

Description

This is a prospective, single arm, multi-center, interventional pivotal study that will enroll up to 194 subjects in up to 35 investigational sites, predominantly in the United States and up to 7 in Canada, Europe, and Japan. Of the 194 subjects, the CMR imaging sub-study will include up to 75 subjects with severe AR already confirmed by TTE. Additionally, up to 40 roll-in subjects may be treated to enable clinical experience and exposure to the device while allowing a reasonable learning curve. The subjects will then be followed 5-years post-procedure of the J-Valve TF System.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. Symptomatic according to New York Heart Association (NYHA) functional class (FC) II or higher 2. Severe AR, defined as follows, as assessed by Imaging Core Laboratory: A. Severe AR by Transthoracic Echocardiography (TTE) (grade 3 or 4) B. OR, if indeterminate AR, by TTE, ANY ONE of the following: i. Cardiac magnetic resonance imaging (CMR)-derived aortic regurgitant fraction (RF) ≥43% ii. CMR-derived RF ≥33% + left ventricular dilation (left ventricular end diastolic volume index \[LVEDVi\]) \>105 mL/m\^2 for men or LVEDVi \>96 mL/m\^2 for women) iii. CMR-de…

Interventions

Device
J-Valve Transfemoral (TF) System
Treatment includes using the J-Valve Transfemoral (TF) System, a transcatheter aortic valve replacement system that consists of the J-Valve TF Bioprosthesis and the J-Valve TF Delivery Device and Loading Accessories, during transcatheter aortic valve replacement (TAVR). The Edwards 16Fr eSheath+ Introducer Set may be used for the introduction and removal of the J-Valve TF System.

Locations (40)

HonorHealth Research & Innovation Institute
Scottsdale, Arizona
Scripps Memorial Hospital La Jolla
La Jolla, California
Cedars Sinai
Los Angeles, California
Stanford University Medical Center
Palo Alto, California
Bay Area Structural Heart at Sutter Health
San Francisco, California
University of California San Francisco
San Francisco, California