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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
Date last updated
22/11/2022

Titles & IDs
Public title
JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study
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)
Secondary ID [1] 0 0
P02C220_JV06EFS_CIP
Secondary ID [2] 0 0
CP-0003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Valve Stenosis 0 0
Heart Valve Diseases 0 0
Heart Diseases 0 0
Cardiovascular Diseases 0 0
Ventricular Outflow Obstruction 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All-Cause Mortality
Timepoint [1] 0 0
30 Day
Secondary outcome [1] 0 0
Myocardial Infarction
Timepoint [1] 0 0
30 Day
Secondary outcome [2] 0 0
All Stroke/TIA
Timepoint [2] 0 0
30 Day
Secondary outcome [3] 0 0
Major Bleeding
Timepoint [3] 0 0
30 Day
Secondary outcome [4] 0 0
Major Vascular Complication
Timepoint [4] 0 0
30 Day
Secondary outcome [5] 0 0
Conduction Disturbance and Arrhythmias
Timepoint [5] 0 0
30 Day
Secondary outcome [6] 0 0
Acute Kidney Injury (AKI)
Timepoint [6] 0 0
30 Day
Secondary outcome [7] 0 0
Coronary Obstruction Requiring Intervention
Timepoint [7] 0 0
30 Day
Secondary outcome [8] 0 0
Endocarditis
Timepoint [8] 0 0
30 Day
Secondary outcome [9] 0 0
Conversion to Surgical Aortic Valve Replacement (SAVR)
Timepoint [9] 0 0
30 Day
Secondary outcome [10] 0 0
THV Malpositioning
Timepoint [10] 0 0
30 Day

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
Minimum age
18 Years
Maximum age
No limit
Sex
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2024
Actual
Sample size
Target
Accrual to date
Final
68
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
District of Columbia
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
Germany
State/province [3] 0 0
Berlin
Country [4] 0 0
Germany
State/province [4] 0 0
Freiburg
Country [5] 0 0
Germany
State/province [5] 0 0
Halle (Saale)
Country [6] 0 0
Germany
State/province [6] 0 0
Hamburg
Country [7] 0 0
Germany
State/province [7] 0 0
Köln
Country [8] 0 0
Germany
State/province [8] 0 0
Stuttgart
Country [9] 0 0
Netherlands
State/province [9] 0 0
Leiden
Country [10] 0 0
Netherlands
State/province [10] 0 0
Nieuwegein
Country [11] 0 0
Netherlands
State/province [11] 0 0
Rotterdam
Country [12] 0 0
New Zealand
State/province [12] 0 0
Auckland
Country [13] 0 0
New Zealand
State/province [13] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
JenaValve Technology, Inc.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT02732691
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.
Public notes

Contacts
Principal investigator
Name 0 0
Martin B Leon, MD
Address 0 0
New York-Presbyterian Hospital/Columbia University Medical Center, USA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02732691