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The JenaValve ALIGN-AR Pivotal Trial

NCT04415047 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2022-09-13

No results posted yet for this study

Summary

To collect information about treatment for symptomatic severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve replacement surgery.

Conditions

  • Aortic Regurgitation
  • Aortic Valve Insufficiency
  • Aortic Insufficiency
  • Aortic Valve Disease

Interventions

DEVICE

JenaValve Trilogy Heart Valve System

TAVR with JenaValve Trilogy Heart Valve System

Sponsors & Collaborators

  • JenaValve Technology, Inc.

    lead INDUSTRY

Principal Investigators

  • Martin B. Leon, MD · New York-Presbyterian/ Columbia University Medical Center

  • Torsten P. Vahl, MD · New York-Presbyterian/ Columbia University Medical Center

  • Vinod H. Thourani, MD · Piedmont Healthcare

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-22
Primary Completion
2023-08-29
Completion
2028-08-31
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 NCT04415047 on ClinicalTrials.gov