J-Valve TF Early Feasibility Study

NCT06034028 | Active Not Recruiting DMC FDA Device

• 1 other identifier: JCM-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Aortic Valve Disease; Aortic Valve Insufficiency; Aortic Regurgitation

Keywords

J-Valve TF System; Transcatheter Aortic Valve Replacement; Transcatheter Aortic Valve Implantation; Transcatheter Heart Valve; Transfemoral; TAVR; TAVI; THV; VHD; Valvular Heart Disease; Valve Disease

Outcome Measures

Primary Outcomes (1)

• Number of patients that do not experience death or disabling stroke

  Freedom from death or disabling stroke Disabling stroke is evaluated using a standardized scale

  30 days after the valve procedure

Secondary Outcomes (9)

• Number of patients and procedures achieving technical success

  At point patient exits the procedure room

• Number of patients and procedures achieving device success

  30 days after the valve procedure

• Number of patients with a safety-related event outcome

  30 days after the valve procedure

• Number of patients experiencing success

  1 year after the valve procedure

• Number of patients meeting clinical efficacy outcome at 2 years

  2 years after the valve procedure

Study Arms (1)

J-Valve TF System

EXPERIMENTAL

Device: J-Valve TF System

Interventions

J-Valve TF System DEVICE

The J-Valve TF System is a transcatheter aortic valve replacement system that consists of the J-Valve TF Bioprosthesis, J-Valve TF Delivery Device, and Loading Accessories.

J-Valve TF System

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has symptomatic (NYHA FC ≥ IIs) severe (≥3+) native AR (per 2020 ACC/AHA Guideline for Management of Patients with Valvular Heart Disease) diagnosed by echocardiography. Patients will be assessed according to the current American Society of Echocardiography Guidelines for Non-invasive Evaluation of Native Valve Regurgitation. Transesophageal echocardiography (TEE) or cardiac MRI (CMR) will be used in case of indeterminant AR;
• Patient is judged by a multi-disciplinary heart team to be at high risk for surgery, based on the ACC/AHA guidelines for management of patients with valvular heart disease: STS-PROM score ≥8%, or if \<8%, significant co-morbidities that are not captured by the STS-PROM score (e.g., ≥2 frailty indices, 1 to 2 major organ system compromise, the presence of certain procedure-specific factors that affect surgical mortality), based on the consensus of a multi-disciplinary heart team;
• Patient or the patient's legal representative has provided written informed consent;
• Patient or patient's legal representative agrees to comply with all required post-procedure follow-up visits.

You may not qualify if:

• Patients that are at prohibitive surgical risk (predicted risk for mortality or major morbidity at 30 days \>50% with SAVR);
• Mixed aortic valve disease, defined as coexistence of \> moderate aortic valve stenosis with severe AR;
• Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, ticlopidine, clopidogrel, Nitinol (Nickel, Titanium, Aluminum) or sensitivity to contrast media, which cannot be adequately premedicated;
• Blood dyscrasias as defined: leukopenia (WBC \<1000 mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy;
• Active infection, including infective endocarditis;
• Liver failure (Child-C);
• Reduced left ventricular function with left ventricular ejection fraction (LVEF) \<25% as measured by resting echocardiogram;
• Uncontrolled atrial fibrillation (e.g., resting heart rate \>120 bpm);
• Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements;
• Renal insufficiency (eGFR \<25) and/or end stage renal disease requiring chronic dialysis;
• Pulmonary Hypertension (systolic pressure ≥2/3 of systemic);
• Severe Chronic Obstructive Pulmonary Disease (COPD) = requiring steroids or requiring continuous home O2
• Severe mitral or severe tricuspid regurgitation or stenosis;
• Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of treatment;
• Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support;

Sponsors & Collaborators

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

Study Sites (9)

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

University at Buffalo

Buffalo, New York, 14203, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Swedish Medical Center Cherry Hill

Seattle, Washington, 98122, United States

Location

Related Publications (1)

• Writing Committee Members; Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2021 Feb 2;77(4):e25-e197. doi: 10.1016/j.jacc.2020.11.018. Epub 2020 Dec 17. No abstract available.

  PMID: 33342586 BACKGROUND

Related Links

• JC Medical, Inc. company website.

MeSH Terms

Conditions

Aortic Valve Disease; Aortic Valve Insufficiency; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Dean J Kereiakes, MD

  The Christ Hospital

  PRINCIPAL INVESTIGATOR

• Michael J Reardon, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 13, 2023
• Study Start: October 16, 2023
• Primary Completion: July 17, 2024
• Study Completion (Estimated): August 25, 2029
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)