J-Valve TF System for Aortic Valve Disease

(JVTF EFS Trial)

Not currently recruiting at 10 trial locations

Overseen By Clinical Affairs

Age: Any Age

Sex: Any

Trial Phase: Academic

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

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

Disqualifiers: Liver failure, Renal insufficiency, COPD, others

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

Compensation: Varies

Number of Visits: 2

Duration: Immediate procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of the J-Valve TF System, a new treatment for severe aortic regurgitation, where the heart valve doesn't close properly. The trial seeks participants who experience symptoms like shortness of breath or fatigue and are considered high-risk for traditional open-heart surgery. It focuses on patients deemed suitable for this less invasive procedure by a heart team. Participants must be willing to attend follow-up visits after the procedure. As an unphased trial, this study allows patients to access innovative treatment options and contribute to advancing medical research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have a known hypersensitivity or contraindication to certain medications like aspirin, heparin, or clopidogrel, you may not be eligible to participate.

What prior data suggests that the J-Valve TF System is safe for aortic valve disease?

Research has shown that the J-Valve TF System is generally safe for individuals with severe aortic valve problems. In one study, after a year, only 5% of patients died from any cause, and 2% experienced a stroke. About 5% required a new pacemaker, a device that helps control heartbeats. Notably, there were only mild leaks around the valve, which is a positive outcome.

Another study reported a high success rate of 96% for the procedure, with an in-hospital death rate of just 3%. This indicates that the treatment is often successful and relatively safe for most patients. Overall, the J-Valve TF System appears to be a good alternative to open-heart surgery for those at high risk, offering hope for individuals with severe aortic valve issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The J-Valve TF System is unique because it offers a minimally invasive approach to treating aortic valve disease, contrasting with traditional open-heart surgery methods. Unlike the standard options which often involve sternotomy, the J-Valve TF System is delivered transcatheter, meaning it can be inserted through a small incision, typically in the groin area, leading to potentially quicker recovery times and less risk of complications. Researchers are excited about this system because it may expand treatment options for patients who are high-risk or ineligible for conventional surgery, providing a promising new alternative in the management of aortic valve disease.

What evidence suggests that the J-Valve TF System is effective for aortic valve disease?

Research has shown that the J-Valve TF System, which participants in this trial will receive, holds promise for patients with severe aortic regurgitation, a condition where the heart's aortic valve doesn't close properly. A review of studies highlights that this device performs well in the short term for severe cases. Additionally, research suggests that the J-Valve could serve as a safe and effective alternative to surgery for those at high risk. Results from a study involving multiple centers demonstrated good safety and effectiveness, making it a potential option for patients who need valve replacement but face high surgical risk. Early results are encouraging, but more experience is needed to confirm these findings. ^{1 2 3 4 6}

Who Is on the Research Team?

Dean J Kereiakes, MD

Principal Investigator

The Christ Hospital

Michael J 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 regurgitation who are at high risk for open heart surgery. Candidates must have the condition confirmed by echocardiography, suitable anatomy for the J-Valve implant, and agree to follow-up visits. Excluded are those with prohibitive surgical risks, mixed valve diseases, certain medical conditions like severe COPD or liver failure, known hypersensitivities, or other specific exclusions.

Inclusion Criteria

Patient or patient's legal representative agrees to comply with all required post-procedure follow-up visits

I have been diagnosed with severe aortic regurgitation.

The patient's heart anatomy is suitable for the J-Valve implantation.

Exclusion Criteria

Known hypersensitivity or contraindication to specific medications or materials

I do not have severe heart, lung, blood, liver, kidney issues, or an active infection.

I have a heart valve condition or a specific body measurement condition.

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 TF System for symptomatic severe native aortic regurgitation

Immediate procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

1 visit (in-person)

Long-term Follow-up

Participants are monitored for long-term safety and effectiveness of the valve

5 years

What Are the Treatments Tested in This Trial?

Interventions

• J-Valve TF System

Trial Overview The study tests the safety and effectiveness of the J-Valve TF System in patients with symptomatic severe native aortic regurgitation who can't undergo standard surgery. The device aims to replace dysfunctional valves without needing open heart surgery.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

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

Lead Sponsor

JC Medical, Inc.

Lead Sponsor

Trials

4

Recruited

330+

Published Research Related to This Trial

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 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 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 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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06034028?term=AREA%5BConditionSearch%5D(%22Aortic%20Valve%20Insufficiency%22)&rank=10

NCT06034028 | J-Valve TF Early Feasibility Study The main objective of this study is to assess the preliminary safety and effectiveness of the J-Valve TF System in patients with symptomatic severe native ...

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

One-year outcomes of a multicenter study on the J-Valve ... We present the first one-year results regarding the safety and efficacy of the J-Valve system implantation in patients with severe aortic stenosis (AS) or ...

3. 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 It may be well suited to patients with non-calcified aortic valve disease and those at risk of coronary obstruction. Further clinical experience is required.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12133853/

Single arm meta-analysis of the J-Valve system for aortic ... This meta-analysis indicates that the J-Valve prosthesis exhibits favorable short-term efficacy in patients with severe aortic regurgitation (AR).

5. jacc.org jacc.org/doi/10.1016/j.jcin.2023.05.018

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

6. journal.hsforum.com journal.hsforum.com/index.php/HSF/article/view/7983

Long-Term Clinical Outcomes of Transcatheter Aortic Valve ... The initial procedural success rate of the J-Valve was remarkably high at 94.44%. There was no significant morphological or hemodynamic ...