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The JenaValve ALIGN-AR LVAD Registry

NCT06594705 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-01

No results posted yet for this study

Summary

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

Conditions

  • Aortic Regurgitation
  • Aortic Valve Insufficiency
  • Aortic Insufficiency
  • Aortic Valve Disease
  • Left Ventricular Dysfunction

Interventions

DEVICE

JenaValve Trilogy Heart Valve System

TAVR with JenaValve Trilogy Heart Valve System

Sponsors & Collaborators

  • JenaValve Technology, Inc.

    lead INDUSTRY

Principal Investigators

  • Nir Uriel, MD · Columbia University

  • Vinod Thourani, MD · Piedmont Heart Institute

  • Ravi Ramana, DO · advocate christ medical center

  • Gabriel Sayer, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-09
Primary Completion
2026-08-31
Completion
2027-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06594705 on ClinicalTrials.gov