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

Aortic Regurgitation Clinical Trial

Official title:

THE ALIGN-AR TRIAL: Safety and Effectiveness/Performance of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients With Symptomatic Severe Aortic Regurgitation (AR)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02732704
• Other study ID #: CP-0004
• Secondary ID: P02C320_JV06EFS_
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 20, 2018
• Est. completion date: September 29, 2027

Study information

• Verified date: November 2022
• Source: JenaValve Technology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study will examine the use of TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System, which is intended to help treat severe aortic regurgitation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 29, 2027
• Est. primary completion date: August 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with severe aortic regurgitation (AR).

• Patient at high risk for open surgical valve replacement

• Patient symptomatic according to NYHA functional class II or higher

• The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/ Ethics Committee (EC) of the respective clinical site.

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

• Severe mitral regurgitation

Related Conditions & MeSH terms

• Aortic Regurgitation
• Aortic Valve Insufficiency

Intervention

Device:
• JenaValve Pericardial TAVR System
TAVR with JenaValve Pericardial Valve and Delivery System

Locations

Country	Name	City	State
Germany	Kerckhoff-Klinik GmbH Bad Nauheim	Bad Nauheim
Germany	Herz- und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen	Bad Oeynhausen
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	Universitätsklinikum Bonn	Bonn
Germany	Universitätsklinikum Frankfurt	Frankfurt
Germany	Universitäres Herzzentrum Hamburg	Hamburg
Germany	Herzzentrum der Universität zu Köln	Köln
Netherlands	Leiden University Medical Center	Leiden
Netherlands	St. Antonius Hospital	Nieuwegein
Netherlands	Erasmus University Medical Center	Rotterdam
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University Hospital	Atlanta	Georgia
United States	Piedmont Healthcare	Atlanta	Georgia
United States	Baylor Scott & White Research Institute	Dallas	Texas
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	New York-Presbyterian/ Columbia University Medical Center	New York	New York
United States	California Pacific Medical Center Research Institute	San Francisco	California
United States	University of Washington	Seattle	Washington
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
JenaValve Technology, Inc.

Countries where clinical trial is conducted

United States,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-Cause Mortality at 30 days	All-Cause mortality within the first 30 days post index procedure	30 days
Secondary	Mortality	Absence of procedural mortality	At 30 days
Secondary	Peri-Procedural Myocardial Infarction	Peri-procedural and spontaneous myocardial infarction	At =72hr after the index procedure
Secondary	Stroke-Free Survival	Disabling or non-disabling stroke	At 30 days and 1 year
Secondary	Bleeding & Vascular Complications	Major and minor bleeding	30 days