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J-Valve TF Early Feasibility Study (JVTF EFS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06034028
Recruitment Status : Recruiting
First Posted : September 13, 2023
Last Update Posted : April 22, 2024
Sponsor:
Information provided by (Responsible Party):
JC Medical, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Aortic Valve Disease Aortic Valve Insufficiency Aortic Regurgitation Device: J-Valve TF System Not Applicable

Detailed Description:
The EFS is a prospective, single arm, multi-center, interventional study that will enroll up to 15 subjects in up to 10 centers in the United States and/or Canada and report the primary endpoint of all-cause death or disabling stroke at 30 days.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: J-Valve TF Early Feasibility Study
Actual Study Start Date : October 16, 2023
Actual Primary Completion Date : March 4, 2024
Estimated Study Completion Date : June 25, 2029
Arms and Interventions
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Arm Intervention/treatment
Experimental: J-Valve TF System Device: J-Valve TF System
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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients that do not experience death or disabling stroke [ Time Frame: 30 days after the valve procedure ]
    Freedom from death or disabling stroke Disabling stroke is evaluated using a standardized scale


Secondary Outcome Measures :
  1. Number of patients and procedures achieving technical success [ Time Frame: At point patient exits the procedure room ]

    Procedures achieving the following:

    • Patient is alive;
    • There was successful access, delivery of the valve, and retrieval of the delivery device;
    • There was correct positioning of a single prosthetic heart valve into the proper anatomical location;
    • There was no need for surgery or intervention due to the device, except permanent pacemaker placement, or for a major complication that it vascular, access-related, or cardiac in nature

  2. Number of patients and procedures achieving device success [ Time Frame: 30 days after the valve procedure ]
    • There was successful access, delivery of the valve, and retrieval of the delivery device;
    • There was correct positioning of a single prosthetic heart valve into the proper anatomical location;
    • There was no need for surgery or intervention due to the device, except permanent pacemaker placement, or for a major complication that it vascular, access-related, or cardiac in nature;
    • Patient is alive;
    • There was not surgery or intervention due to the device, except permanent pacemaker placement, or for a major complication that it vascular, access-related, or cardiac in nature;
    • The valve was performing as intended, measured by echocardiography

  3. Number of patients with a safety-related event outcome [ Time Frame: 30 days after the valve procedure ]

    Freedom from:

    • All-cause death;
    • All stroke;
    • Valve Academic Research Consortium (VARC)-3 type 2-4 bleeding;
    • Major vascular, access-related, or cardiac structural complication;
    • Acute kidney injury stage 3 or 4;
    • Moderate or severe aortic regurgitation;
    • New permanent pacemaker due to procedure related conduction abnormalities;
    • Surgery or intervention related to the device.

  4. Number of patients experiencing success [ Time Frame: 1 year after the valve procedure ]

    No re-hospitalization or re-interventions for the underlying condition and improvement, from baseline, in symptoms, which are measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) score.

    Success in an increase from baseline of 10 or more points on the KCCQ-OS score.


  5. Number of patients meeting clinical efficacy outcome at 2 years [ Time Frame: 2 years after the valve procedure ]
    • Freedom-from all-cause death;
    • Freedom from all stroke;
    • Freedom from hospitalization for procedure- or valve-related causes;
    • Freedom from KCCQ-OS score < 45 or decline from baseline of >10 points;
    • Good Outcome: Alive with change in KCCQ-OS score >=10 points;
    • Excellent outcome: Alive with change in KCCQ-OS score >=20 points.

  6. Number of patients meeting clinical efficacy outcome at 3 years [ Time Frame: 3 years after the valve procedure ]
    • Freedom-from all-cause death;
    • Freedom from all stroke;
    • Freedom from hospitalization for procedure- or valve-related causes;
    • Freedom from KCCQ-OS score < 45 or decline from baseline of >10 points;
    • Good Outcome: Alive with change in KCCQ-OS score >=10 points;
    • Excellent outcome: Alive with change in KCCQ-OS score >=20 points.

  7. Number of patients meeting clinical efficacy outcome at 4 years [ Time Frame: 4 years after the valve procedure ]
    • Freedom-from all-cause death;
    • Freedom from all stroke;
    • Freedom from hospitalization for procedure- or valve-related causes;
    • Freedom from KCCQ-OS score < 45 or decline from baseline of >10 points;
    • Good Outcome: Alive with change in KCCQ-OS score >=10 points;
    • Excellent outcome: Alive with change in KCCQ-OS score >=20 points.

  8. Number of patients meeting clinical efficacy outcome at 5 years [ Time Frame: 5 years after the valve procedure ]
    • Freedom-from all-cause death;
    • Freedom from all stroke;
    • Freedom from hospitalization for procedure- or valve-related causes;
    • Freedom from KCCQ-OS score < 45 or decline from baseline of >10 points;
    • Good Outcome: Alive with change in KCCQ-OS score >=10 points;
    • Excellent outcome: Alive with change in KCCQ-OS score >=20 points.

  9. Number of patients achieving long-term clinical efficacy for valve function [ Time Frame: 5 years after the valve procedure ]

    Freedom from:

    • Bioprosthetic valve failure (defined as Valve-related mortality or aortic valve re-operation/re-intervention or Stage 3 hemodynamic valve deterioration);
    • Stroke or peripheral embolism (presumably valve- related, after ruling out other non-valve etiologies);
    • VARC-3 Type 2-4 bleeding secondary to or exacerbated by antiplatelet
    • or anticoagulant agents, used specifically for valve- related concerns.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 has suitable anatomy for J-Valve implantation (see anatomic exclusions below);
  • 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.

Exclusion Criteria:

  • 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;
  • Recent (within 6 months of treatment) cerebrovascular accident (CVA) or transient ischemic attack (TIA);
  • Active gastrointestinal (GI) bleeding that would preclude anticoagulation;
  • Untreated multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery;
  • Evidence of acute myocardial infarction within 1 month of intended procedure;
  • PCI within 30 days of intended procedure;
  • Estimated life expectancy of less than 24 months due to associated (excluding cardiac) co-morbid conditions;
  • Left Ventricular Assist Device (LVAD) dependent;
  • Participating in another study that may influence the outcome of this study;
  • Need for emergency surgery for any reason;
  • Previous aortic bioprosthesis or mechanical implant.

Anatomic Exclusion Criteria:

  • Ascending Aortic diameter >5 cm;
  • Aortic Annulus Perimeter <57 mm or >104 mm;
  • Access vessel minimum diameter <5.5 mm;
  • LVEDD >75 mm;
  • Bicuspid aortic valve disease;
  • Congenital univentricle or other condition that, in the opinion of the investigator and/or consulting physician, may constitute an unwarranted surgical risk.
  • Abdominal aortic aneurysm ≥ 4.0 cm;
  • Aorto-iliac disease requiring intervention to facilitate delivery of access sheath;
  • Excessive tortuosity of delivery system pathway, defined as severe tortuosity of multiple vessels including iliofemoral, descending aorta, ascending aorta, aortic arch, and aortic angle >80⁰. In most cases, this exclusion will be identified and assigned following review by the multi-disciplinary Screening Committee.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06034028


Contacts
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Contact: Clinical Affairs 650-477-2781 info@jcmedicalinc.com

Locations
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United States, Arizona
HonorHealth Active, not recruiting
Scottsdale, Arizona, United States, 85258
United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Erin Collins, MPH       erin.c.collins@medstar.net   
Principal Investigator: Ron Waksman, MD         
United States, Illinois
Advocate Christ Medical Center Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Colleen Gallagher       Colleen.Gallagher@aah.org   
Principal Investigator: Ravi Ramana, DO         
United States, Louisiana
Cardiovascular Institute of the South Recruiting
Houma, Louisiana, United States, 70360
Contact: Deanna Benoit, LPN, CCRC       Deanna.Benoit@cardio.com   
Principal Investigator: Peter S Fail, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Kara Booth       kbooth@montefiore.org   
Principal Investigator: Mohamed Azeem Latib, MD         
University at Buffalo Recruiting
Buffalo, New York, United States, 14203
Contact: Courtney Bishop, MS, MPH       cabishop@buffalo.edu   
Principal Investigator: Vijay Iyer, MD         
United States, Ohio
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Darlene Rock, MBA, BSN, RN       Darlene.rock@thechristhospital.com   
Principal Investigator: Santiago A Garcia, MD         
United States, Texas
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Rene Plascencia, CCRP       rplascencia@houstonmethodist.org   
Principal Investigator: Sachin Goel, MD         
United States, Washington
Swedish Medical Center Cherry Hill Recruiting
Seattle, Washington, United States, 98122
Contact: Jennifer Nagel       Jennifer.Nagel@Swedish.org   
Principal Investigator: Sameer Gafoor, MD         
Sponsors and Collaborators
JC Medical, Inc.
Investigators
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Principal Investigator: Dean J Kereiakes, MD The Christ Hospital
Principal Investigator: Michael J Reardon, MD The Methodist Hospital Research Institute
More Information
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Additional Information:

Publications:

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Responsible Party: JC Medical, Inc.
ClinicalTrials.gov Identifier: NCT06034028    
Other Study ID Numbers: JCM-001
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: April 22, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by JC Medical, Inc.:
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
Additional relevant MeSH terms:
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Aortic Valve Disease
Aortic Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases