Brief Title
THE ALIGN-AS EFS TRIAL: JenaValve Pericardial TAVR Aortic Stenosis Study
Official Title
THE ALIGN-AS TRIAL: Safety and Effectiveness/Performance of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients With Symptomatic Severe Aortic Stenosis (AS)
Brief 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.
Detailed 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.
Study Type
Interventional
Primary Outcome
All-Cause Mortality at 30 Days
Secondary Outcome
Mortality
Condition
Aortic Valve Stenosis
Intervention
JenaValve Pericardial TAVR System
Study Arms / Comparison Groups
Transcatheter Aortic Valve Replacement (TAVR)
Description: Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve pericardial valve and delivery system.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
90
Start Date
February 2016
Completion Date
June 2025
Primary Completion Date
May 2019
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Martin B Leon, MD, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT02732691
Organization ID
CP-0003
Secondary IDs
P02C220_JV06EFS_CIP
Responsible Party
Sponsor
Study Sponsor
JenaValve Technology, Inc.
Study Sponsor
Martin B Leon, MD, Study Chair, New York-Presbyterian Hospital/Columbia University Medical Center, USA
Verification Date
March 2022