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JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study

J

JenaValve Technology

Status

Active, not recruiting

Conditions

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

Treatments

Device: JenaValve Pericardial TAVR System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02732691
CA-0001 EU (Other Identifier)
CA-0010 (Other Identifier)
P02C220_JV06EFS_CIP (Other Identifier)
CP-0003
CA-0001 Germany (Other Identifier)

Details and patient eligibility

About

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.

Full description

This study will examine the use of a TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. This less invasive surgical approach called TAVR is offered to those patients who are high risk for undergoing open heart surgery to replace the aortic valve. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System.

Enrollment

68 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient with severe degenerative native aortic stenosis (AS).
  • Patient at high risk for open surgical valve replacement
  • Patient symptomatic according to NYHA functional class II or higher

Exclusion criteria

  • Congenital uni- or bicuspid aortic valve morphology
  • Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
  • Endocarditis or other active infection
  • Need for urgent or emergent TAVR procedure for any reason
  • Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

68 participants in 1 patient group

Transcatheter Aortic Valve Replacement (TAVR)
Experimental group
Description:
Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve pericardial valve and delivery system.
Treatment:
Device: JenaValve Pericardial TAVR System

Trial documents
1

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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