J-Valve TF System for Aortic Valve Disease

(JVTF EFS Trial)

Recruiting at 8 trial locations

Overseen by Michael J Reardon, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: JC Medical, Inc.

No Placebo Group

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.

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.

Treatment Details

Interventions

• J-Valve TF System (Procedure)

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+