J-Valve TF Early Feasibility Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-16

Study Completion Date

2029-08-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Aortic Valve Disease Aortic Valve Insufficiency Aortic Regurgitation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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J-Valve TF System

Group Type EXPERIMENTAL

J-Valve TF System

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

* 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No