J-Valve Transfemoral System for Aortic Regurgitation

(JOURNEY Trial)

Not currently recruiting at 21 trial locations

Overseen By Sheri L Halverson, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: JC Medical, Inc.

Must not be taking: Antithrombotics, Aspirin, Heparin, others

Disqualifiers: Prosthetic valve, Severe stenosis, Infection, Renal insufficiency, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 30 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new heart valve system called the J-Valve Transfemoral System. The goal is to determine its safety and effectiveness for individuals with severe aortic valve regurgitation, a condition where the heart valve leaks and causes blood to flow backward. It targets those with noticeable symptoms who are considered too risky for standard heart surgery. Participants must have a heart condition that meets specific criteria, such as symptoms affecting daily life. The trial also examines how the heart changes after treatment and how these changes might differ between men and women. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for heart valve conditions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on antithrombotic therapy (medications that prevent blood clots), you should be able to tolerate it, as the trial excludes those who cannot.

What prior data suggests that the J-Valve Transfemoral System is safe for treating aortic regurgitation?

Research has shown that the J-Valve Transfemoral System is generally well-tolerated by patients with severe aortic regurgitation, a condition where the heart valve doesn't close properly. One study reported that 5 out of 100 patients died from any cause within a year. Additionally, 2 out of 100 patients experienced a stroke, and 5 out of 100 required new pacemakers. Only mild leaks around the valve were observed, indicating a positive safety profile. These findings suggest that the J-Valve offers a promising alternative to surgery for high-risk patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The J-Valve Transfemoral (TF) System is unique because it offers a minimally invasive approach for treating aortic regurgitation, a condition where the heart's aortic valve doesn't close tightly, causing blood to flow backward. Unlike traditional open-heart surgery, the J-Valve is delivered through the transfemoral route, meaning it's inserted through a small incision in the groin, reducing recovery time and surgical risks. Researchers are excited about this treatment because it could provide a safer, less invasive option for patients who are high-risk for conventional surgery, potentially improving their quality of life and outcomes.

What evidence suggests that the J-Valve Transfemoral System is effective for aortic regurgitation?

Research has shown that the J-Valve Transfemoral System, which participants in this trial will receive, could be a promising treatment for severe aortic regurgitation, a condition where the heart's aortic valve doesn't close properly. Studies have found it to be a safe and effective option, especially for patients at high risk for traditional open-heart surgery. The system uses a special design with U-shaped anchor rings to secure the valve, effectively addressing the problem. Early results suggest it offers positive outcomes and serves as a good alternative for those unable to undergo open-heart surgery. Overall, the J-Valve Transfemoral System may benefit patients with severe aortic valve issues. ^{1 2 6 7 8}

Who Is on the Research Team?

Tsuyoshi Kaneko, MD

Principal Investigator

Washington University School of Medicine

Dean J Kereiakes, MD

Principal Investigator

The Christ Hospital Heart & Vascular Institute

Santiago Garcia, MD

Principal Investigator

The Christ Hospital and The Carl and Edyth Lindner Center for Research and Education

Michael Reardon, MD

Principal Investigator

The Methodist Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for patients with severe aortic valve regurgitation or mixed aortic disease, who are at high risk for open heart surgery. They must have specific levels of regurgitant fraction and ventricular dilation or reduced ejection fraction as measured by cardiac MRI, be symptomatic according to NYHA class II or higher, and have suitable anatomy for the J-Valve TF System.

Inclusion Criteria

I experience symptoms when I exert myself physically.

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-derived RF ≥33% + LV ejection fraction (LVEF) ≤55% or left-ventricular end-systolic volume index (LVESVi) ≥ 43ml/m^2;

I have signed the consent form for this trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the J-Valve Transfemoral System for aortic regurgitation

30 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Multiple visits (in-person and virtual)

Long-term follow-up

Participants are followed for long-term outcomes post-procedure

5 years

What Are the Treatments Tested in This Trial?

Interventions

• J-Valve Transfemoral (TF) System

Trial Overview The study tests the safety and effectiveness of the J-Valve Transfemoral (TF) System in treating severe native aortic valve regurgitation in high-risk patients. It compares their outcomes to those typically expected with traditional surgical replacement.

How Is the Trial Designed?

Group I: J-Valve Transfemoral (TF) System Experimental Treatment 1 Intervention

J-Valve Transfemoral (TF) System is already approved in United States for the following indications:

Approved in United States as J-Valve TF System for:

• Severe native aortic regurgitation (AR)
• AR-dominant mixed aortic valve disease

Who Is Running the Clinical Trial?

JC Medical, Inc.

Lead Sponsor

Trials

4

Recruited

330+

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

Lead Sponsor

Cardiovascular Research Foundation, New York

Collaborator

Trials

28

Recruited

27,800+

Bright Research Partners

Industry Sponsor

Trials

18

Recruited

2,700+

Minneapolis Heart Institute Foundation

Collaborator

Trials

32

Recruited

15,700+

Published Research Related to This Trial

The J-Valve system demonstrated a high technique success rate of 91.3% in a study of 23 high-risk patients undergoing transapical transcatheter aortic valve replacement, indicating its efficacy in treating aortic valve diseases.

The J-Valve system is particularly advantageous for patients with pure aortic regurgitation, and the procedure showed low rates of complications, with no cases of moderate or severe paravalvular leakage reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transapical Transcatheter Valve Replacement Using J-Valve for Aortic Valve Diseases. Xue, Y., Zhou, Q., Li, S., et al.[2021]

The J-Valve system demonstrated a high procedural success rate of 91.6% in 107 high-risk patients with severe aortic stenosis or regurgitation, indicating its efficacy in treating aortic valvular disease.

At one year post-implantation, the J-Valve showed low rates of all-cause mortality (5.0%) and stroke (2%), along with significant improvements in heart function and quality of life, suggesting it is a safe option for patients undergoing transcatheter aortic valve implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A versatile transapical device for aortic valvular disease: One-year outcomes of a multicenter study on the J-Valve system. Tung, M., Wang, X., Li, F., et al.[2019]

The J-Valve™ system is a new second-generation transcatheter aortic valve implantation (TAVI) device designed specifically for high-risk patients with pure aortic regurgitation, showcasing its potential as an effective treatment option in this challenging patient population.

This device features innovative 'graspers' that allow for intuitive self-positioning during implantation and provide enhanced fixation by embracing the native valve leaflets, which may improve the overall success of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transapical implantation of a new second-generation transcatheter heart valve in patients with pure aortic regurgitation: a preliminary report. Zhu, D., Chen, Y., Zhang, J., et al.[2016]

The J-Valve system was successfully implanted in all six patients with predominant aortic regurgitation, demonstrating its feasibility for high-risk individuals who are not suitable for traditional surgical valve replacement.

During a follow-up period averaging 110 days, there were no major complications or mortality, indicating that the J-Valve system is a safe option for patients with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A New Transcatheter Aortic Valve Replacement System for Predominant Aortic Regurgitation Implantation of the J-Valve and Early Outcome. Wei, L., Liu, H., Zhu, L., et al.[2016]

Transcatheter aortic valve implantation (TAVI) using the J-Valve™ system was successfully performed in 95% of patients with aortic stenosis or aortic regurgitation, demonstrating its efficacy as a treatment option for high-risk individuals.

No mortality occurred within 90 days post-procedure, and the majority of patients experienced significant improvements in heart function, with minimal complications such as only one case of pacemaker implantation needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transapical transcatheter aortic valve implantation using a new second-generation TAVI system - J-Valve™ for high-risk patients with aortic valve diseases: Initial results with 90-day follow-up. Zhu, D., Chen, Y., Guo, Y., et al.[2020]

The J-Valve(TM) prosthesis has been successfully implanted in a high-risk patient with pure aortic regurgitation, marking the first human use of this device for this condition.

This innovative valve design features U-shaped graspers that allow for intuitive self-positioning and secure fixation, which may enhance the effectiveness of transcatheter aortic valve implantation (TAVI) in patients with non-calcified aortic regurgitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful transcatheter aortic valve implantation for pure aortic regurgitation using a new second generation self-expanding J-Valve(TM) system - the first in-man implantation. Zhu, D., Hu, J., Meng, W., et al.[2015]

The J-Valve transcatheter aortic valve replacement system was successfully implanted in 95.3% of the 107 high-risk patients studied, demonstrating its efficacy in treating severe aortic valve diseases.

The procedure significantly reduced mean aortic gradients from 56.7 mm Hg to 14.4 mm Hg, indicating improved blood flow, while the overall mortality rate was 4.7% at both 30 days and 6 months, suggesting a relatively safe profile for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transapical transcatheter aortic valve replacement with a novel transcatheter aortic valve replacement system in high-risk patients with severe aortic valve diseases. Zhu, L., Guo, Y., Wang, W., et al.[2019]

The J-Valve™ system was successfully implanted in 16 elderly patients with predominant aortic incompetence, demonstrating feasibility for high-risk individuals who are not candidates for traditional surgery.

Postoperative outcomes were generally positive, with only one patient experiencing a serious complication, while the majority showed no significant valve incompetence or major complications during follow-up, indicating the procedure's safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transapical transcatheter aortic valve replacement for high risk elderly patients with predominant aortic incompetence]. Liu, H., Wei, L., Yang, Y., et al.[2018]

Citations

1. eurointervention.pcronline.com eurointervention.pcronline.com/article/first-in-human-experience-of-a-new-generation-transfemoral-transcatheter-aortic-valve-for-the-treatment-of-severe-aortic-regurgitation-the-j-valve-transfemoral-system

the J-Valve transfemoral system The J-Valve transcatheter aortic valve consists of the valve and three U-shaped “anchor rings” (Figure 1A) and is deployed in a two-step process.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06455787

NCT06455787 | J-Valve Transfemoral Pivotal Study 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. jacc.org jacc.org/doi/10.1016/j.jcin.2023.05.018

Transcatheter Treatment of Native Aortic Valve Regurgitation The J-Valve appears to provide a safe and effective alternative to surgery in patients with pure AR and elevated or prohibitive surgical risk.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30451688/

the J-Valve transfemoral system First-in-human experience of a new-generation transfemoral transcatheter aortic valve for the treatment of severe aortic regurgitation: the J-Valve transfemoral ...

5. withpower.com withpower.com/trial/phase-aortic-valve-disease-6-2024-00c9e

J-Valve Transfemoral System for Aortic Regurgitation · Info ... Studies have reported positive outcomes in terms of safety and effectiveness for patients with severe aortic valve conditions, suggesting potential benefits for ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S091450871830193X

One-year outcomes of a multicenter study on the J-Valve ... At 1 year, the all-cause mortality was 5.0%, stroke 2%, and rate of new pacemakers 5.0%. Only mild paravalvular leak was reported. Among the patients with AS, ...

7. media.pcronline.com media.pcronline.com/diapos/PCRLondon2024/5303-20241126_1218_Room_4_Wei_Lai_1100000_(27908)/Wei_Lai_20241126_1215_Room_4.pdf

30-day outcomes of J-VALVE transfemoral for chronic ... To evaluate the effectiveness and safety of the J-VALVE transcatheter aortic valve system amongst patients with symptomatic severe aortic regurgitation who are ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12102353/

Efficacy and safety of transfemoral TAVR in pure aortic ... The objective of this study was to evaluate the efficacy of transcatheter aortic valve replacement (TAVR) via the femoral approach in patients ...