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JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study

NCT02732691 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2022-11-22

Study results available
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Summary

To collect information about treatment for severe aortic stenosis (AS), which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes symptoms such as chest pain, fainting and shortness of breath. The preferred treatment for severe aortic stenosis is aortic valve replacement surgery.

Conditions

  • Aortic Valve Stenosis
  • Heart Valve Diseases
  • Heart Diseases
  • Cardiovascular Diseases
  • Ventricular Outflow Obstruction

Interventions

DEVICE

JenaValve Pericardial TAVR System

Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.

Sponsors & Collaborators

  • JenaValve Technology, Inc.

    lead INDUSTRY

Principal Investigators

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

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

  • Vinod H Thourani, MD · Piedmont Heart Institute, USA

  • Hendrik Treede, MD · University Hospital Bonn, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-21
Primary Completion
2019-05-28
Completion
2024-04-30

Countries

  • United States
  • Germany
  • Netherlands
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

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 NCT02732691 on ClinicalTrials.gov