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

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: NCT02732704
Recruitment Status : Active, not recruiting
First Posted : April 11, 2016
Last Update Posted : November 18, 2022
Sponsor:
Information provided by (Responsible Party):
JenaValve Technology, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Aortic Regurgitation Device: JenaValve Pericardial TAVR 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 severe aortic regurgitation.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : April 20, 2018
Actual Primary Completion Date : August 29, 2022
Estimated Study Completion Date : September 29, 2027
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. All-Cause Mortality at 30 days [ Time Frame: 30 days ]
    All-Cause mortality within the first 30 days post index procedure


Secondary Outcome Measures :
  1. Mortality [ Time Frame: At 30 days ]
    Absence of procedural mortality

  2. Peri-Procedural Myocardial Infarction [ Time Frame: At ≤72hr after the index procedure ]
    Peri-procedural and spontaneous myocardial infarction

  3. Stroke-Free Survival [ Time Frame: At 30 days and 1 year ]
    Disabling or non-disabling stroke

  4. Bleeding & Vascular Complications [ Time Frame: 30 days ]
    Major and minor bleeding


Eligibility Criteria
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Information from the National Library of Medicine

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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): NCT02732704


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
Principal Investigator: Stephan Baldus, MD Herzzentrum der Universität zu Köln
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: JenaValve Technology, Inc.
ClinicalTrials.gov Identifier: NCT02732704    
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 ( Other Identifier: JenaValve Technology Inc. )
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: November 18, 2022
Last Verified: November 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.:
Aortic Valve Disease
Aortic Regurgitation
Aortic Insufficiency
Additional relevant MeSH terms:
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Aortic Valve Insufficiency
Aortic Valve Disease
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases