JOURNEY (JCM-002)
Research type
Research Study
Full title
JOURNEY: J-Valve to treat aortic regurgitation via transcatheter therapy
IRAS ID
353082
Contact name
Sam Dawkins
Contact email
Sponsor organisation
JC Medical Inc., a wholly owned subsidiary of Edwards Lifesciences Corporation and an affiliate of
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 4 months, 31 days
Research summary
Aortic regurgitation (AR) occurs in approximately 0.4% of all adults, in 1% of individuals aged 65-74 years and 2% of individuals over 70 years of age.
Symptomatic patients with chronic severe AR have a poor prognosis and should therefore undergo surgical aortic valve replacement (SAVR) per current guidelines.
SAVR is an open-heart surgery that necessitates the use of cardiopulmonary bypass as well as cardiac arrest. This extensive intervention, performed under general anesthesia, can jeopardize vital organ functions, particularly in older patients, potentially leading to increased morbidity and mortality.
The current guidelines note that the use of TAVI in severe AR patients should be carefully considered only in select cases with prohibitive surgical risk, where valvular calcification and annular size are suitable for TAVI. Therefore, the JOURNEY study is proposed to evaluate the safety and efficacy of the J-Valve® TF System in treatment of patients with symptomatic, severe (grade 3 or 4) native aortic valve regurgitation and AR-dominant mixed aortic valve disease who are at high risk for surgical valve replacement.The study will be conducted at up to 35 sites in the United states, Canada, UK, France and Japan and the study completion is expected in 2031. Participants will undergo medical assessments at the following intervals: screening, procedure (implant of the study device), discharge, 30 days, 6 months, 1 year and annually through 5 years.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
25/SC/0180
Date of REC Opinion
17 Jul 2025
REC opinion
Further Information Favourable Opinion