J-Valve Transfemoral Pivotal Study (JOURNEY)

JC Medical, Inc., an affiliate of Edwards Lifesciences LLC

Status

Enrolling

Conditions

Aortic Valve Regurgitation

Aortic Valve Disease Mixed

Treatments

Device: J-Valve Transfemoral (TF) System

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06455787

JCM-002

Details and patient eligibility

About

The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed aortic valve disease, who are judged by a multi-disciplinary heart team to be at high risk for open surgical aortic valve replacement (SAVR).

A Cardiac Magnetic Resonance (CMR) sub-study will examine if intervention for AR translates to improved ventricular remodeling, the impact of LV remodeling on clinical outcomes and quality of life, as well as volumetric and myocardial differences between genders.

Full description

This is a prospective, single arm, multi-center, interventional pivotal study that will enroll up to 194 subjects in up to 35 investigational sites, predominantly in the United States and up to 7 in Canada, Europe, and Japan. Of the 194 subjects, the CMR imaging sub-study will include up to 75 subjects with severe AR already confirmed by TTE. Additionally, up to 40 roll-in subjects may be treated to enable clinical experience and exposure to the device while allowing a reasonable learning curve. The subjects will then be followed 5-years post-procedure of the J-Valve TF System.

Enrollment

194 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Symptomatic according to New York Heart Association (NYHA) functional class (FC) II or higher
Severe AR, defined as follows, as assessed by Imaging Core Laboratory:

A. Severe AR by Transthoracic Echocardiography (TTE) (grade 3 or 4)

B. OR, if indeterminate AR, by TTE, ANY ONE of the following:

i. Cardiac magnetic resonance imaging (CMR)-derived aortic regurgitant fraction (RF) ≥43% ii. CMR-derived RF ≥33% + left ventricular dilation (left ventricular end diastolic volume index [LVEDVi]) >105 mL/m^2 for men or LVEDVi >96 mL/m^2 for women) iii. CMR-derived RF ≥33% + LV ejection fraction (LVEF) ≤55% or left ventricular end systolic volume index (LVESVi) ≥43mL/m^2; iv. Severe AR by Transesophageal Echocardiography (TEE) (grade 3 or 4)
High risk for surgery as judged by a multi-disciplinary heart team
Suitable anatomy to accommodate the insertion, delivery, and deployment of the study devices (see anatomic exclusions below)
Written informed consent and agreement to comply with all required post-procedure follow-up visits at investigational site.

Exclusion criteria

Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
Aortic valve stenosis > moderate*
Severe mitral valve or tricuspid valve regurgitation*
Severe mitral valve or tricuspid valve stenosis*
Active infection, including infective endocarditis
Cardiac imaging evidence of cardiac mass, thrombus or vegetation
Inability to tolerate or a condition precluding treatment with antithrombotic (antiplatelet, anticoagulant) therapy
Renal insufficiency (eGFR <30 mL/min/1.73m^2) or end stage renal disease requiring chronic dialysis
Liver disease (cirrhosis of the liver [Child-Pugh Class B or C])
Blood dyscrasias as defined: leukopenia (WBC <3000 cells/mcL), thrombocytopenia (platelet count <50,000 cells/mcL), anemia (hemoglobin <9 g/dL), history of bleeding diathesis coagulopathy, or hypercoagulable state (unless therapeutically stable)
Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, Nitinol (Nickel, Titanium) or sensitivity to contrast media, which cannot be adequately premedicated
Left ventricular dysfunction with left ventricular ejection fraction (LVEF) <25% as measured by resting echocardiogram (or by CMR, when performed)*
Clinically significant untreated coronary artery disease requiring revascularization or anticipated coronary revascularization procedure within 12-months post index procedure
Acute myocardial infarction within 30 days prior to index procedure
PCI within 30 days prior to index procedure
Carotid intervention within 6 weeks prior to index procedure or carotid artery disease requiring intervention
Previous, or planned, other surgical or interventional procedures within 30 days before, during, or within 30 days after the index procedure
Uncontrolled atrial fibrillation
Severe right ventricular (RV) dysfunction*
Pulmonary hypertension (systolic PA pressure >70mmHg or systolic PA pressure ≥2/3 of systemic systolic BP)
Severe chronic obstructive pulmonary disease (COPD) requiring chronic oral steroids or requiring continuous home O2
Stroke (CVA), transient ischemic attack (TIA) or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to index procedure
Cardiogenic shock defined as systolic blood pressure <90 mmHg in addition to signs of tissue hypoperfusion or the need for vasopressors and/or mechanical hemodynamic support to maintain systolic blood pressure ≥90mmHg
Patient requires mechanical circulatory support within 30 days prior to index procedure
Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions
Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements
Participation in another investigational study that has not reached its primary endpoint
Considered to be part of a vulnerable population
- As assessed by Imaging Core Laboratory

Anatomic Exclusions:

Ascending Aortic diameter >5 cm*
Aortic Annulus Perimeter <57 mm or >104 mm*
Inappropriate anatomy for femoral introduction and delivery of the study system
Left ventricular end-diastolic diameter (LVEDD) >75 mm*
Congenital aortic valve disease including Unicuspid, Bicuspid, or Quadricuspid aortic valve anatomy*
Congenital univentricle or other condition that, in the opinion of the investigator and/or consulting physician, may constitute an unwarranted surgical risk
Excessive aortic valve prolapse that would preclude proper seating of the implant in the aortic annulus
Abdominal/thoracic aortic aneurysm ≥5.0 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, thoracoabdominal aorta, aortic arch, or LV-aortic root angle >80⁰
- As assessed by Imaging Core Laboratory