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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04415047
Recruitment Status : Active, not recruiting
First Posted : June 4, 2020
Last Update Posted : September 13, 2022
Sponsor:
Information provided by (Responsible Party):
JenaValve Technology, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Aortic Regurgitation Aortic Valve Insufficiency Aortic Insufficiency Aortic Valve Disease Device: JenaValve Trilogy Heart Valve System Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : May 22, 2020
Estimated Primary Completion Date : August 29, 2023
Estimated Study Completion Date : August 2028
Arms and Interventions
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Arm Intervention/treatment
Experimental: Transcatheter Aortic Valve Replacement (TAVR)
TAVR with JenaValve Trilogy Heart Valve System Intervention Device: JenaValve Trilogy Heart Valve System
 Device: JenaValve Trilogy Heart Valve System
TAVR with JenaValve Trilogy Heart Valve System


Outcome Measures
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Primary Outcome Measures :
  1. All-Cause Mortality at 1 Year [ Time Frame: 1 year ]
    All-cause mortality within the first 12 months post index procedure

  2. All Stroke [ Time Frame: 30 days ]
    Number of patients that had a stroke

  3. Major Bleeding [ Time Frame: 30 days ]
    Number of patients that had any of these events

  4. Acute Kidney Injury [ Time Frame: 30 days ]
    Number of patients that had these events

  5. Major Vascular Complications [ Time Frame: 30 days ]
    Number of patients that had these events

  6. Surgery/intervention related to the device [ Time Frame: 30 days ]
    Number of patients that had these events

  7. Permanent pacemaker implantation [ Time Frame: 30 days ]
    Number of patients that had these events

  8. Total aortic regurgitation [ Time Frame: 30 days ]
    Number of patients that had these events


Secondary Outcome Measures :
  1. KCCQ [ Time Frame: 1 year ]
    KCCQ Improvement


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04415047


Locations
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Sponsors and Collaborators
JenaValve Technology, Inc.
Investigators
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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
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: JenaValve Technology, Inc.
ClinicalTrials.gov Identifier: NCT04415047    
Other Study ID Numbers: P02C320
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: September 13, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by JenaValve Technology, Inc.:
Valvular Heart Disease
Aortic Incompetence
Aortic Valve Incompetence
Additional relevant MeSH terms:
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Aortic Valve Disease
Aortic Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases