The JenaValve ALIGN-AR LVAD Registry

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJenaValve Technology, Inc.

About this trial

To evaluate the safety and effectiveness of the JenaValve Trilogy™ 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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • JenaValve Trilogy Heart Valve System

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators