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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02732704
Registration number
NCT02732704
Ethics application status
Date submitted
18/03/2016
Date registered
11/04/2016
Date last updated
18/11/2022
Titles & IDs
Public title
THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study
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Scientific 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)
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Secondary ID [1]
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P02C320_JV06EFS_CIP
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Secondary ID [2]
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CP-0004
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Aortic Regurgitation
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - JenaValve Pericardial TAVR System
Experimental: Transcatheter Aortic Valve Replacement (TAVR) - TAVR with JenaValve Pericardial Valve and Delivery System
Treatment: Devices: JenaValve Pericardial TAVR System
TAVR with JenaValve Pericardial Valve and Delivery System
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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All-Cause Mortality at 30 days
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Assessment method [1]
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All-Cause mortality within the first 30 days post index procedure
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Timepoint [1]
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30 days
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Secondary outcome [1]
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Mortality
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Assessment method [1]
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Absence of procedural mortality
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Timepoint [1]
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At 30 days
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Secondary outcome [2]
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Peri-Procedural Myocardial Infarction
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Assessment method [2]
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Peri-procedural and spontaneous myocardial infarction
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Timepoint [2]
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At =72hr after the index procedure
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Secondary outcome [3]
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Stroke-Free Survival
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Assessment method [3]
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Disabling or non-disabling stroke
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Timepoint [3]
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At 30 days and 1 year
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Secondary outcome [4]
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Bleeding & Vascular Complications
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Assessment method [4]
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Major and minor bleeding
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Timepoint [4]
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30 days
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/04/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
29/09/2027
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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District of Columbia
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United States of America
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Georgia
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United States of America
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Michigan
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United States of America
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New York
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Texas
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United States of America
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Washington
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Germany
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Bad Nauheim
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Germany
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State/province [9]
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Bad Oeynhausen
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Frankfurt
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Germany
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Hamburg
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Germany
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Köln
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Netherlands
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Leiden
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Netherlands
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State/province [16]
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Nieuwegein
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Netherlands
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State/province [17]
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Rotterdam
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
JenaValve Technology, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02732704
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Martin B. Leon, MD
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Address
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New York-Presbyterian/ Columbia University Medical Center
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02732704
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