J-Valve Transfemoral Pivotal Study

Recruiting now · Not applicable

Conditions studied: Aortic Valve Regurgitation, Aortic Valve Disease Mixed

In brief

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.

Key facts

Study ID

NCT06455787

Run by

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

People needed

194

Starts

2024-10-17

Expected to finish

2032-02-01

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• HonorHealth Research & Innovation Institute — Scottsdale, Arizona, United States (enrolling)
• Scripps Memorial Hospital La Jolla — La Jolla, California, United States (enrolling)
• Cedars Sinai — Los Angeles, California, United States (enrolling)
• Stanford University Medical Center — Palo Alto, California, United States (enrolling)
• Bay Area Structural Heart at Sutter Health — San Francisco, California, United States (enrolling)
• University of California San Francisco — San Francisco, California, United States (enrolling)
• UC Health Northern Colorado (Medical Center of the Rockies) — Loveland, Colorado, United States (enrolling)
• Washington Hospital Center DC — Washington D.C., District of Columbia, United States (enrolling)
• NCH Rooney Heart Institute — Naples, Florida, United States (enrolling)
• Emory University Atlanta — Atlanta, Georgia, United States (enrolling)
• Piedmont — Atlanta, Georgia, United States (enrolling)
• Northwestern University Chicago — Chicago, Illinois, United States (enrolling)
• Glenbrook - Endeavor Health — Glenview, Illinois, United States (enrolling)
• Ascension Via Christi — Wichita, Kansas, United States (enrolling)
• Cardiovascular Institute of the South — Houma, Louisiana, United States (enrolling)
• Massachusetts General Hospital Boston — Boston, Massachusetts, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• Henry Ford Hospital Detroit — Detroit, Michigan, United States (enrolling)
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States (enrolling)
• CentraCare Heart and Vascular Center — Saint Cloud, Minnesota, United States (enrolling)
• Washington University - Barnes-Jewish Hospital St. Louis — St Louis, Missouri, United States (enrolling)
• University at Buffalo - Kaleida Health — Buffalo, New York, United States (enrolling)
• Columbia University Irving Medical Center/New York-Presbyterian Hospital — New York, New York, United States (enrolling)
• St. Francis Hospital — Roslyn, New York, United States (enrolling)
• Montefiore Medical Center — The Bronx, New York, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.