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THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study

NCT02732704 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-11-18

No results posted yet for this study

Summary

To collect information about treatment for 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

Interventions

DEVICE

JenaValve Pericardial TAVR System

TAVR with JenaValve Pericardial Valve and Delivery 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

  • Stephan Baldus, MD · Herzzentrum der Universität zu Köln

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-20
Primary Completion
2022-08-29
Completion
2027-09-29
FDA Device
Yes

Countries

  • United States
  • Germany
  • Netherlands

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 NCT02732704 on ClinicalTrials.gov