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

Primary Purpose

Aortic Regurgitation

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
JenaValve Pericardial TAVR System
Sponsored by
JenaValve Technology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Regurgitation focused on measuring Aortic Valve Disease, Aortic Regurgitation, Aortic Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars Sinai Medical Center
  • California Pacific Medical Center Research Institute
  • MedStar Washington Hospital Center
  • Piedmont Healthcare
  • Emory University Hospital
  • University of Michigan
  • New York-Presbyterian/ Columbia University Medical Center
  • Baylor Scott & White Research Institute
  • University of Washington
  • Kerckhoff-Klinik GmbH Bad Nauheim
  • Herz- und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen
  • Deutsches Herzzentrum Berlin
  • Universitätsklinikum Bonn
  • Universitätsklinikum Frankfurt
  • Universitäres Herzzentrum Hamburg
  • Herzzentrum der Universität zu Köln
  • Leiden University Medical Center
  • St. Antonius Hospital
  • Erasmus University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcatheter Aortic Valve Replacement (TAVR)

Arm Description

TAVR with JenaValve Pericardial Valve and Delivery System

Outcomes

Primary Outcome Measures

All-Cause Mortality at 30 days
All-Cause mortality within the first 30 days post index procedure

Secondary Outcome Measures

Mortality
Absence of procedural mortality
Peri-Procedural Myocardial Infarction
Peri-procedural and spontaneous myocardial infarction
Stroke-Free Survival
Disabling or non-disabling stroke
Bleeding & Vascular Complications
Major and minor bleeding

Full Information

First Posted
March 18, 2016
Last Updated
November 16, 2022
Sponsor
JenaValve Technology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02732704
Brief Title
THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 20, 2018 (Actual)
Primary Completion Date
August 29, 2022 (Actual)
Study Completion Date
September 29, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JenaValve Technology, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Regurgitation
Keywords
Aortic Valve Disease, Aortic Regurgitation, Aortic Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcatheter Aortic Valve Replacement (TAVR)
Arm Type
Experimental
Arm Description
TAVR with JenaValve Pericardial Valve and Delivery System
Intervention Type
Device
Intervention Name(s)
JenaValve Pericardial TAVR System
Intervention Description
TAVR with JenaValve Pericardial Valve and Delivery System
Primary Outcome Measure Information:
Title
All-Cause Mortality at 30 days
Description
All-Cause mortality within the first 30 days post index procedure
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Mortality
Description
Absence of procedural mortality
Time Frame
At 30 days
Title
Peri-Procedural Myocardial Infarction
Description
Peri-procedural and spontaneous myocardial infarction
Time Frame
At ≤72hr after the index procedure
Title
Stroke-Free Survival
Description
Disabling or non-disabling stroke
Time Frame
At 30 days and 1 year
Title
Bleeding & Vascular Complications
Description
Major and minor bleeding
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin B. Leon, MD
Organizational Affiliation
New York-Presbyterian/ Columbia University Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Torsten P. Vahl, MD
Organizational Affiliation
New York-Presbyterian/ Columbia University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vinod H. Thourani, MD
Organizational Affiliation
Piedmont Healthcare
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephan Baldus, MD
Organizational Affiliation
Herzzentrum der Universität zu Köln
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
California Pacific Medical Center Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Piedmont Healthcare
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
New York-Presbyterian/ Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Baylor Scott & White Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75201
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Kerckhoff-Klinik GmbH Bad Nauheim
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Herz- und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Facility Name
Deutsches Herzzentrum Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitätsklinikum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt
ZIP/Postal Code
60323
Country
Germany
Facility Name
Universitäres Herzzentrum Hamburg
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Herzzentrum der Universität zu Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2333
Country
Netherlands
Facility Name
St. Antonius Hospital
City
Nieuwegein
ZIP/Postal Code
3435
Country
Netherlands
Facility Name
Erasmus University Medical Center
City
Rotterdam
ZIP/Postal Code
3062
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34556282
Citation
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.
Results Reference
derived

Learn more about this trial

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

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