J-Valve Transfemoral System for Aortic Regurgitation

(JOURNEY Trial)

Recruiting at 7 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

194 Participants Needed

Trial Summary

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 data supports the effectiveness of the J-Valve Transfemoral System treatment for aortic regurgitation?

The J-Valve system has shown favorable results in treating aortic valve diseases, including aortic regurgitation, when used in a transapical approach. Studies have reported positive outcomes in terms of safety and effectiveness for patients with severe aortic valve conditions, suggesting potential benefits for the transfemoral approach as well. ^{1 2 3 4 5}

Is the J-Valve Transfemoral System generally safe for humans?

The J-Valve system has been used in patients with aortic valve diseases, including aortic stenosis and aortic regurgitation, and studies have shown favorable safety results in these conditions. ^{1 4 5 6 7}

How is the J-Valve Transfemoral System treatment different from other treatments for aortic regurgitation?

The J-Valve Transfemoral System is unique because it uses a transcatheter approach with three U-shaped graspers that allow for intuitive self-positioning and secure fixation by embracing the native valve leaflets, making it suitable for patients with aortic regurgitation, especially those who are high-risk or inoperable. ^{1 4 5 6 8}

What is the purpose of this trial?

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.

Research Team

Tsuyoshi Kaneko, MD

Principal Investigator

Washington University School of Medicine

Michael Reardon, MD

Principal Investigator

The Methodist Hospital Research Institute

Santiago Garcia, MD

Principal Investigator

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

Dean J Kereiakes, MD

Principal Investigator

The Christ Hospital Heart & Vascular Institute

Eligibility Criteria

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;

A team of heart specialists has determined I am at high risk for heart surgery.

Timeline

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

Treatment Details

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.

Participant Groups

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+

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+

Findings from Research

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]

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]

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]

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]

References

1. United States 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. [2019]

2. China pubmed.ncbi.nlm.nih.gov

[Transapical transcatheter aortic valve replacement for high risk elderly patients with predominant aortic incompetence]. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

A New Transcatheter Aortic Valve Replacement System for Predominant Aortic Regurgitation Implantation of the J-Valve and Early Outcome. [2016]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Transapical Transcatheter Valve Replacement Using J-Valve for Aortic Valve Diseases. [2021]

5. Netherlands 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. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Transapical implantation of a new second-generation transcatheter heart valve in patients with pure aortic regurgitation: a preliminary report. [2016]

7. Netherlands 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. [2020]

8. Australia 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. [2015]