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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02732704




Registration number
NCT02732704
Ethics application status
Date submitted
18/03/2016
Date registered
11/04/2016
Date last updated
9/03/2020

Titles & IDs
Public title
THE ALIGN-AR TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study
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)
Secondary ID [1] 0 0
P02C320_JV06EFS_CIP
Secondary ID [2] 0 0
CP-0004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Regurgitation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All-Cause Mortality at 30 days - All-Cause mortality within the first 30 days post index procedure
Timepoint [1] 0 0
30 days
Secondary outcome [1] 0 0
Mortality - Absence of procedural mortality
Timepoint [1] 0 0
30 days
Secondary outcome [2] 0 0
Myocardial Infarction - Peri-procedural and spontaneous myocardial infarction
Timepoint [2] 0 0
30 days
Secondary outcome [3] 0 0
Neurological Complications - Disabling or non-disabling stroke
Timepoint [3] 0 0
30 days
Secondary outcome [4] 0 0
Bleeding & Vascular Complications - Major and minor bleeding
Timepoint [4] 0 0
30 days

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Germany
State/province [9] 0 0
Bad Nauheim
Country [10] 0 0
Germany
State/province [10] 0 0
Bad Oeynhausen
Country [11] 0 0
Germany
State/province [11] 0 0
Berlin
Country [12] 0 0
Germany
State/province [12] 0 0
Bonn
Country [13] 0 0
Germany
State/province [13] 0 0
Frankfurt
Country [14] 0 0
Germany
State/province [14] 0 0
Hamburg
Country [15] 0 0
Germany
State/province [15] 0 0
Köln
Country [16] 0 0
Netherlands
State/province [16] 0 0
Leiden
Country [17] 0 0
Netherlands
State/province [17] 0 0
Nieuwegein
Country [18] 0 0
Netherlands
State/province [18] 0 0
Rotterdam
Country [19] 0 0
New Zealand
State/province [19] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
JenaValve Technology, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Cardiovascular Research Foundation, New York
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02732704
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Martin B. Leon, MD
Address 0 0
New York-Presbyterian/ Columbia University Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Vinny Podichetty
Address 0 0
Country 0 0
Phone 0 0
9493967510
Fax 0 0
Email 0 0
podichetty@jenavalve.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02732704