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

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Regurgitation
• Intervention / Treatment: Device: JenaValve Pericardial TAVR System

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad Nauheim, Germany, 61231
    • Kerckhoff-Klinik GmbH Bad Nauheim
  • Bad Oeynhausen, Germany, 32545
    • Herz- und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen
  • Berlin, Germany, 13353
    • Deutsches Herzzentrum Berlin
  • Bonn, Germany, 53127
    • Universitätsklinikum Bonn
  • Frankfurt, Germany, 60323
    • Universitätsklinikum Frankfurt
  • Hamburg, Germany, 20246
    • Universitäres Herzzentrum Hamburg
  • Köln, Germany, 50937
    • Herzzentrum der Universität zu Köln
• Netherlands
  • Leiden, Netherlands, 2333
    • Leiden University Medical Center
  • Nieuwegein, Netherlands, 3435
    • St. Antonius Hospital
  • Rotterdam, Netherlands, 3062
    • Erasmus University Medical Center
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
    • San Francisco, California, United States, 94109
      • California Pacific Medical Center Research Institute
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30309
      • Piedmont Healthcare
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • New York
    • New York, New York, United States, 10032
      • New York-Presbyterian/ Columbia University Medical Center
  • Texas
    • Dallas, Texas, United States, 75201
      • Baylor Scott & White Research Institute
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcatheter Aortic Valve Replacement (TAVR); TAVR with JenaValve Pericardial Valve and Delivery System	Device: JenaValve Pericardial TAVR System; TAVR with JenaValve Pericardial Valve and Delivery System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-Cause Mortality at 30 days	All-Cause mortality within the first 30 days post index procedure	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Absence of procedural mortality	At 30 days
Peri-Procedural Myocardial Infarction	Peri-procedural and spontaneous myocardial infarction	At ≤72hr after the index procedure
Stroke-Free Survival	Disabling or non-disabling stroke	At 30 days and 1 year
Bleeding & Vascular Complications	Major and minor bleeding	30 days

Collaborators and Investigators

• Sponsor: JenaValve Technology, Inc.
• Investigators: Study Chair: Martin B. Leon, MD, New York-Presbyterian/ Columbia University Medical Center; Principal Investigator: Torsten P. Vahl, MD, New York-Presbyterian/ Columbia University Medical Center; Principal Investigator: Vinod H. Thourani, MD, Piedmont Healthcare; Principal Investigator: Stephan Baldus, MD, Herzzentrum der Universität zu Köln

Publications and helpful links

General Publications

• Hamid N, Ranard LS, Khalique OK, Hahn RT, Nazif TM, George I, Ng V, Leon MB, Kodali SK, Vahl TP. Commissural Alignment After Transfemoral Transcatheter Aortic Valve Replacement With the JenaValve Trilogy System. JACC Cardiovasc Interv. 2021 Sep 27;14(18):2079-2081. doi: 10.1016/j.jcin.2021.07.025. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2018
• Primary Completion (Actual): August 29, 2022
• Study Completion (Anticipated): September 29, 2027

Study Registration Dates

• First Submitted: March 18, 2016
• First Submitted That Met QC Criteria: April 8, 2016
• First Posted (Estimate): April 11, 2016

Study Record Updates

• Last Update Posted (Actual): November 18, 2022
• Last Update Submitted That Met QC Criteria: November 16, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Aortic Valve Disease; Aortic Regurgitation; Aortic Insufficiency
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Aortic Valve Insufficiency
• Other Study ID Numbers: CP-0004; P02C320_JV06EFS_CIP (Other Identifier: JenaValve Technology Inc.); CA-0002 EU (Other Identifier: JenaValve Technology Inc.); CA-0002 Germany (Other Identifier: JenaValve Technology Inc.); CA-0011 (JenaValve Technology Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes