The JenaValve ALIGN-AR LVAD Registry (NCT06594705) | Clinical Trial Compass
RecruitingNot Applicable
The JenaValve ALIGN-AR LVAD Registry
United States50 participantsStarted 2024-12-09
Plain-language summary
To evaluate the safety and effectiveness of the JenaValve Trilogyâ„¢ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR) who are indicated for TAVR
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subjects \>=18 years of age with continuous flow LVAD (cfLVAD) with clinically significant AR1 leading to cfLVAD dysfunction using cfLVAD ASE guidelines that utilize contemporary management strategies for measurement of AR in patients with cfLVAD2,3:
✓. Patient with NYHA functional class III/IV
✓. Patient with high risk for SAVR as documented by Heart Team.
✓. Patient has suitable anatomy to accommodate the insertion and delivery of the JenaValve Trilogy™ Heart Valve System
✓. Patient or the patient's legal representative has provided written informed consent
✓. Patient or the patient's legal representative agrees to comply with all required post-procedure follow-up visits
Exclusion criteria
✕. Congenital uni- or bicuspid (Sievers 0) aortic valve morphology
✕. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
✕. Mitral regurgitation \> moderate
✕. Clinically significant coronary artery disease (CAD) requiring revascularization within 30 days prior to index procedure, or planned CAD revascularization procedure within 12 months after index procedure
✕. Echocardiographic or CT evidence of left ventricular or aortic valve thrombus