Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02732691
Registration number
NCT02732691
Ethics application status
Date submitted
18/03/2016
Date registered
11/04/2016
Titles & IDs
Public title
JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study
Query!
Scientific title
JENAVALVE ALIGN-AS TRIAL: Safety and Effectiveness/Performance of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients With Symptomatic Severe Aortic Stenosis (AS)
Query!
Secondary ID [1]
0
0
P02C220_JV06EFS_CIP
Query!
Secondary ID [2]
0
0
CP-0003
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Aortic Valve Stenosis
0
0
Query!
Heart Valve Diseases
0
0
Query!
Heart Diseases
0
0
Query!
Cardiovascular Diseases
0
0
Query!
Ventricular Outflow Obstruction
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Coronary heart disease
Query!
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Cardiovascular
0
0
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Other
0
0
0
0
Query!
Research that is not of generic health relevance and not applicable to specific health categories listed above
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Devices - JenaValve Pericardial TAVR System
Experimental: Transcatheter Aortic Valve Replacement (TAVR) - Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve pericardial valve and delivery system.
Treatment: Devices: JenaValve Pericardial TAVR System
Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
All-Cause Mortality
Query!
Assessment method [1]
0
0
All-cause mortality rate at 30 Day
Query!
Timepoint [1]
0
0
30 Day
Query!
Secondary outcome [1]
0
0
Myocardial Infarction
Query!
Assessment method [1]
0
0
Peri-procedural and spontaneous myocardial infarction
Query!
Timepoint [1]
0
0
30 Day
Query!
Secondary outcome [2]
0
0
All Stroke/TIA
Query!
Assessment method [2]
0
0
Neurological Complications
Query!
Timepoint [2]
0
0
30 Day
Query!
Secondary outcome [3]
0
0
Major Bleeding
Query!
Assessment method [3]
0
0
Life threatening or major bleeding
Query!
Timepoint [3]
0
0
30 Day
Query!
Secondary outcome [4]
0
0
Major Vascular Complication
Query!
Assessment method [4]
0
0
Major vascular and bleeding complications
Query!
Timepoint [4]
0
0
30 Day
Query!
Secondary outcome [5]
0
0
Conduction Disturbance and Arrhythmias
Query!
Assessment method [5]
0
0
Conduction system injury (defect), including AV block, which may require a permanent pacemaker
Query!
Timepoint [5]
0
0
30 Day
Query!
Secondary outcome [6]
0
0
Acute Kidney Injury (AKI)
Query!
Assessment method [6]
0
0
Number of patients who were diagnosed with AKI Stage 2 or 3:
AKI Stage 2: Increase in serum creatinine to 200%-299% (2.0%-2.99% increase compared with baseline) OR urine output \<0.5 mL/kg/h for \>12 but \<24 h
AKI Stage 3: Increase in serum creatinine to =300% (\>3 × increase compared with baseline) OR serum creatinine of =4.0 mg/dL (=354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L) OR urine output \<0.3 ml/kg/h for =24 h OR anuria for =12 h
Query!
Timepoint [6]
0
0
30 Day
Query!
Secondary outcome [7]
0
0
Coronary Obstruction Requiring Intervention
Query!
Assessment method [7]
0
0
Coronary obstruction post-implant requiring intervention
Query!
Timepoint [7]
0
0
30 Day
Query!
Secondary outcome [8]
0
0
Endocarditis
Query!
Assessment method [8]
0
0
Bacterial endocarditis
Query!
Timepoint [8]
0
0
30 Day
Query!
Secondary outcome [9]
0
0
Conversion to Surgical Aortic Valve Replacement (SAVR)
Query!
Assessment method [9]
0
0
Number of patients who underwent conversion to open sternotomy during the TAVR procedure secondary to any procedure-related complications
Query!
Timepoint [9]
0
0
30 Day
Query!
Secondary outcome [10]
0
0
THV Malpositioning
Query!
Assessment method [10]
0
0
Number of patients who experienced:
Migration: After initial correct positioning, the valve prosthesis moves upwards or downwards, within the aortic annulus from its initial position, with or without consequences
Embolization: The valve prosthesis moves during or after deployment such that it loses contact with the aortic annulus
Ectopic Valve Deployment: Permanent deployment of the valve prosthesis in a location other than the aortic root
Query!
Timepoint [10]
0
0
30 Day
Query!
Eligibility
Key inclusion criteria
* Patient with severe degenerative native aortic stenosis (AS).
* Patient at high risk for open surgical valve replacement
* Patient symptomatic according to NYHA functional class II or higher
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
NA
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
21/10/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/04/2024
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
68
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
District of Columbia
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
New York
Query!
Country [3]
0
0
Germany
Query!
State/province [3]
0
0
Berlin
Query!
Country [4]
0
0
Germany
Query!
State/province [4]
0
0
Freiburg
Query!
Country [5]
0
0
Germany
Query!
State/province [5]
0
0
Halle (Saale)
Query!
Country [6]
0
0
Germany
Query!
State/province [6]
0
0
Hamburg
Query!
Country [7]
0
0
Germany
Query!
State/province [7]
0
0
Köln
Query!
Country [8]
0
0
Germany
Query!
State/province [8]
0
0
Stuttgart
Query!
Country [9]
0
0
Netherlands
Query!
State/province [9]
0
0
Leiden
Query!
Country [10]
0
0
Netherlands
Query!
State/province [10]
0
0
Nieuwegein
Query!
Country [11]
0
0
Netherlands
Query!
State/province [11]
0
0
Rotterdam
Query!
Country [12]
0
0
New Zealand
Query!
State/province [12]
0
0
Auckland
Query!
Country [13]
0
0
New Zealand
Query!
State/province [13]
0
0
Hamilton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
JenaValve Technology, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
To collect information about treatment for severe aortic stenosis (AS), which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes symptoms such as chest pain, fainting and shortness of breath. The preferred treatment for severe aortic stenosis is aortic valve replacement surgery.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02732691
Query!
Trial related presentations / publications
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. 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. 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. 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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Martin B Leon, MD
Query!
Address
0
0
New York-Presbyterian Hospital/Columbia University Medical Center, USA
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/91/NCT02732691/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/91/NCT02732691/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02732691