J-Valve TF System for Aortic Valve Disease

(JVTF EFS Trial)

Recruiting at 8 trial locations

Overseen By Clinical Affairs

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: JC Medical, Inc.

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

25 Participants Needed

Trial Summary

What is the purpose of this trial?

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 aortic regurgitation who are judged by a multi-disciplinary heart team to be eligible for the device and to be at high risk for open surgical aortic valve replacement.

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 data supports the effectiveness of the J-Valve TF System treatment for aortic valve disease?

Research shows that the J-Valve system, used for aortic valve diseases like aortic stenosis (narrowing of the valve) and aortic regurgitation (leakage of the valve), has been effective in high-risk patients, with studies reporting favorable outcomes and accurate positioning of the valve. ^{1 2 3 4 5}

Is the J-Valve TF System safe for humans?

The J-Valve system has been used in studies for patients with aortic valve diseases, showing favorable safety results over one year. It has been tested in high-risk patients with severe aortic conditions, and early outcomes suggest it is generally safe for human use. ^{1 2 3 4 5}

What makes the J-Valve TF System treatment unique for aortic valve disease?

The J-Valve TF System is unique because it is specifically designed for transapical transcatheter aortic valve replacement, featuring three U-shaped graspers that help in accurate positioning. This makes it suitable for treating both aortic stenosis (narrowing of the valve) and aortic regurgitation (leakage of the valve), even in patients without significant valve calcification. ^{1 2 3 4 5}

Research Team

Dean J Kereiakes, MD

Principal Investigator

The Christ Hospital

Michael J Reardon, MD

Principal Investigator

The Methodist Hospital Research Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Who Is Running the Clinical Trial?

JC Medical, Inc.

Lead Sponsor

Trials

4

Recruited

330+

Findings from Research

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]

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]

References

1. China pubmed.ncbi.nlm.nih.gov

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

2. 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]

3. Netherlands pubmed.ncbi.nlm.nih.gov

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

4. 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]

5. 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]