Clinical trial NCT06034028: J-Valve TF Early Feasibility Study
Official title: J-Valve TF Early Feasibility Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: JC Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-13
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: The EFS is a prospective, single arm, multi-center, interventional study that will enroll up to 25 subjects in up to 15 centers in the United States and/or Canada and report the primary endpoint of all-cause death or disabling stroke at 30 days.

Eligibility 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.

Primary outcomes:
measure: Number of patients that do not experience death or disabling stroke
timeFrame: 30 days after the valve procedure
Secondary outcomes:
measure: Number of patients and procedures achieving technical success
timeFrame: At point patient exits the procedure room
measure: Number of patients and procedures achieving device success
timeFrame: 30 days after the valve procedure
measure: Number of patients with a safety-related event outcome
timeFrame: 30 days after the valve procedure
measure: Number of patients experiencing success
timeFrame: 1 year after the valve procedure
measure: Number of patients meeting clinical efficacy outcome at 2 years
timeFrame: 2 years after the valve procedure
measure: Number of patients meeting clinical efficacy outcome at 3 years
timeFrame: 3 years after the valve procedure
measure: Number of patients meeting clinical efficacy outcome at 4 years
timeFrame: 4 years after the valve procedure
measure: Number of patients meeting clinical efficacy outcome at 5 years
timeFrame: 5 years after the valve procedure
measure: Number of patients achieving long-term clinical efficacy for valve function
timeFrame: 5 years after the valve procedure
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth
state: Arizona
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center Cherry Hill
state: Washington
Study officials:
affiliation: The Christ Hospital
name: Dean J Kereiakes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Methodist Hospital Research Institute
name: Michael J Reardon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.