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The JenaValve ALIGN-AR Pivotal Trial (ALIGN-AR)

Primary Purpose

Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
JenaValve Trilogy Heart Valve 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 Valvular Heart Disease, Aortic Incompetence, Aortic Valve Incompetence

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

  • TMC HealthCare & PIMA Heart
  • Cedars Sinai Medical Center
  • Scripps Hospital
  • California Pacific Medical Center Research Institute
  • MedStar Washington Hospital Center
  • Morton Plant/ BayCare Health
  • Piedmont Healthcare
  • Emory University Hospital
  • Cardiac Surgery Clinical Research Center Inc./ Advocate Aurora Health
  • University of Maryland Medical Center
  • University of Michigan
  • Henry Ford Health System
  • Minneapolis Heart Institute/ Abbott Northwestern
  • Barnes-Jewish Hospital / Washington University
  • Rutgers Robert Wood Johnson Medical School/ Rutgers Robert Wood University Hospital
  • New York-Presbyterian/ Columbia University Medical Center
  • The Christ Hospital
  • Cleveland Clinic Foundation
  • Ohio Health Research Institute
  • Oregon Health & Science University
  • Allegheny-Singer Health Network
  • Lankenau
  • Medical University of South Carolina
  • Methodist Le Bonheur Healthcare
  • Baylor Scott & White Research Institute
  • Houston Methodist
  • Memorial Hermann - Texas Medical Center
  • Intermountain Medical Center Heart Institute
  • Sentara Hospitals
  • University of Washington

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcatheter Aortic Valve Replacement (TAVR)

Arm Description

TAVR with JenaValve Trilogy Heart Valve System Intervention Device: JenaValve Trilogy Heart Valve System

Outcomes

Primary Outcome Measures

All-Cause Mortality at 1 Year
All-cause mortality within the first 12 months post index procedure
All Stroke
Number of patients that had a stroke
Major Bleeding
Number of patients that had any of these events
Acute Kidney Injury
Number of patients that had these events
Major Vascular Complications
Number of patients that had these events
Surgery/intervention related to the device
Number of patients that had these events
Permanent pacemaker implantation
Number of patients that had these events
Total aortic regurgitation
Number of patients that had these events

Secondary Outcome Measures

KCCQ
KCCQ Improvement

Full Information

First Posted
May 31, 2020
Last Updated
September 7, 2022
Sponsor
JenaValve Technology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04415047
Brief Title
The JenaValve ALIGN-AR Pivotal Trial
Acronym
ALIGN-AR
Official Title
A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Heart Valve System in the Treatment of High Surgical Risk Patients With Symptomatic, Severe Aortic Regurgitation (AR)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 22, 2020 (Actual)
Primary Completion Date
August 29, 2023 (Anticipated)
Study Completion Date
August 2028 (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 symptomatic 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 symptomatic severe aortic regurgitation.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Transcatheter Aortic Valve Replacement (TAVR)
Arm Type
Experimental
Arm Description
TAVR with JenaValve Trilogy Heart Valve System Intervention Device: JenaValve Trilogy Heart Valve System
Intervention Type
Device
Intervention Name(s)
JenaValve Trilogy Heart Valve System
Intervention Description
TAVR with JenaValve Trilogy Heart Valve System
Primary Outcome Measure Information:
Title
All-Cause Mortality at 1 Year
Description
All-cause mortality within the first 12 months post index procedure
Time Frame
1 year
Title
All Stroke
Description
Number of patients that had a stroke
Time Frame
30 days
Title
Major Bleeding
Description
Number of patients that had any of these events
Time Frame
30 days
Title
Acute Kidney Injury
Description
Number of patients that had these events
Time Frame
30 days
Title
Major Vascular Complications
Description
Number of patients that had these events
Time Frame
30 days
Title
Surgery/intervention related to the device
Description
Number of patients that had these events
Time Frame
30 days
Title
Permanent pacemaker implantation
Description
Number of patients that had these events
Time Frame
30 days
Title
Total aortic regurgitation
Description
Number of patients that had these events
Time Frame
30 days
Secondary Outcome Measure Information:
Title
KCCQ
Description
KCCQ Improvement
Time Frame
1 year

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
Facility Information:
Facility Name
TMC HealthCare & PIMA Heart
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Scripps Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92121
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
Morton Plant/ BayCare Health
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
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
Cardiac Surgery Clinical Research Center Inc./ Advocate Aurora Health
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Minneapolis Heart Institute/ Abbott Northwestern
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Barnes-Jewish Hospital / Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Rutgers Robert Wood Johnson Medical School/ Rutgers Robert Wood University Hospital
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08901
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
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio Health Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Allegheny-Singer Health Network
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Lankenau
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Methodist Le Bonheur Healthcare
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Baylor Scott & White Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75201
Country
United States
Facility Name
Houston Methodist
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Memorial Hermann - Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Intermountain Medical Center Heart Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84111
Country
United States
Facility Name
Sentara Hospitals
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28314623
Citation
Zoghbi WA, Adams D, Bonow RO, Enriquez-Sarano M, Foster E, Grayburn PA, Hahn RT, Han Y, Hung J, Lang RM, Little SH, Shah DJ, Shernan S, Thavendiranathan P, Thomas JD, Weissman NJ. Recommendations for Noninvasive Evaluation of Native Valvular Regurgitation: A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr. 2017 Apr;30(4):303-371. doi: 10.1016/j.echo.2017.01.007. Epub 2017 Mar 14. No abstract available.
Results Reference
background
PubMed Identifier
28298458
Citation
Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017 Jun 20;135(25):e1159-e1195. doi: 10.1161/CIR.0000000000000503. Epub 2017 Mar 15. No abstract available.
Results Reference
background
PubMed Identifier
12831818
Citation
Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003 Jul;24(13):1231-43. doi: 10.1016/s0195-668x(03)00201-x.
Results Reference
background
PubMed Identifier
35568645
Citation
Geyer M, Tamm AR, Munzel T, Treede H, von Bardeleben RS. Novel Transfemoral TAVR System to Treat Aortic Regurgitation in Degenerated Surgical Aortic Valve Replacement Even in Unfavorable Anatomy. JACC Cardiovasc Interv. 2022 Jun 13;15(11):e135-e136. doi: 10.1016/j.jcin.2022.02.043. Epub 2022 May 11. No abstract available.
Results Reference
background
PubMed Identifier
34647465
Citation
Poschner T, Werner P, Kocher A, Laufer G, Musumeci F, Andreas M, Russo M. The JenaValve pericardial transcatheter aortic valve replacement system to treat aortic valve disease. Future Cardiol. 2022 Feb;18(2):101-113. doi: 10.2217/fca-2021-0065. Epub 2021 Oct 14.
Results Reference
background
PubMed Identifier
34317595
Citation
Ng VG, Khalique OK, Nazif T, Patel A, Hamid N, George I, Bapat V, Hahn R, Kodali S, Vahl TP. Treatment of Acute Aortic Insufficiency With a Dedicated Device. JACC Case Rep. 2021 Mar 24;3(4):645-649. doi: 10.1016/j.jaccas.2021.01.021. eCollection 2021 Apr.
Results Reference
background
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

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The JenaValve ALIGN-AR Pivotal Trial

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