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Trial registered on ANZCTR


Registration number
ACTRN12616000717459
Ethics application status
Approved
Date submitted
14/12/2015
Date registered
30/05/2016
Date last updated
5/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A feasibility study to assess the safety and efficacy of JenaValve for patients with severe aortic stenosis (AS).
Scientific title
A Feasibility Study to Assess Safety and Efficacy of the Transapical and Transfemoral JenaValve Pericardial TAVR (Transcatheter Aortic Valve Replacement) System in the Treatment of Patients with Symptomatic Severe Aortic Stenosis (AS)
Secondary ID [1] 288142 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Stenosis 297053 0
Condition category
Condition code
Cardiovascular 297280 297280 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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. The JenaValve Pericardial TAVR System will be examined in this clinical study for aortic valve replacement. The TAVR procedure is performed by a heart surgeon and a cardiologist. The TAVR device may be implanted transapical, which is placed through your chest wall, or transfemoral, which is placed though an artery in your groin. The choice of which which approach is used is at the clinical discretion of the study physicians.. The TAVR procedure typically takes 1-2 hours to complete. The JenaValve TAVR device, once implanted, is designed to remain permanently in place.
Intervention code [1] 293454 0
Treatment: Devices
Comparator / control treatment
Nil- single-arm study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296858 0
All-cause mortality (adjudicated)
Timepoint [1] 296858 0
30 days post-index procedure
Secondary outcome [1] 319546 0
Event rate of VARC-2 individual safety endpoints, including:
- All-cause mortality (assessed by review of medical records)
Timepoint [1] 319546 0
At 1 month, 6 months, 1 year, and 2 years post-index procedure.
Secondary outcome [2] 319547 0
- Myocardial infarction (assessed by review of medical records)
Timepoint [2] 319547 0
At 1 month, 6 months, 1 year, and 2 years post-index procedure.
Secondary outcome [3] 323002 0
- Neurologic complications- all cause stroke and transient ischemic attack (TIA) (assessed by review of medical records)
Timepoint [3] 323002 0
At 1 month, 6 months, 1 year, and 2 years post-index procedure.
Secondary outcome [4] 323005 0
- Bleeding complications (assessed by review of medical records)
Timepoint [4] 323005 0
At 1 month, 6 months, 1 year, and 2 years post-index procedure.
Secondary outcome [5] 323572 0
- Acute kidney injury (AKIN classification) (assessed by review of medical records)
Timepoint [5] 323572 0
Within 7 days post-index procedure.
Secondary outcome [6] 323573 0
- Vascular complications (Major, minor, closure device failure) (assessed by review of medical records)
Timepoint [6] 323573 0
At 1 month, 6 months, 1 year, and 2 years post-index procedure.
Secondary outcome [7] 323574 0
- Conduction disturbances and arrhythmias (assessed by review of medical records)
Timepoint [7] 323574 0
At 1 month, 6 months, 1 year, and 2 years post-index procedure.
Secondary outcome [8] 323575 0
- TAVR-related complications (assessed by review of medical records)
Timepoint [8] 323575 0
At 1 month, 6 months, 1 year, and 2 years post-index procedure.
Secondary outcome [9] 323576 0
Functional classification assessed using the New York Heart Association (NYHA) functional class.
Timepoint [9] 323576 0
At 1 month, 6 months, 1 year, and 2 years post-index procedure, as compared to baseline.

Secondary outcome [10] 323577 0
Clinical outcome assessed using the 6 Minute Walk Test (6MWT).
Timepoint [10] 323577 0
At 6 months, 1 year, and 2 years post-index procedure, as compared to baseline.
Secondary outcome [11] 323578 0
Clinical outcome assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Timepoint [11] 323578 0
At 1 year and 2 years post-index procedure, as compared to baseline.

Eligibility
Key inclusion criteria
1. Patient with severe degenerative native aortic stenosis (AS)
2. Patient at high risk for open surgical valve replacement
3. 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
1. Congenital uni- or bicuspid aortic valve morphology
2. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
3. Endocarditis or other active infection
4. Need for urgent or emergent TAVR procedure for any reason
5. Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Safety
Statistical methods / analysis
This study is a single-arm, multi-center, prospective feasibility study that is exploratory in nature. It is anticipated that a maximum of 30 mITT (modified intention to treat) subjects will be included to initially assess the safety and feasibility of the procedure and investigational device.
Continuous outcome variables will be presented as means and standard deviations, as well as medians and ranges. For categorical outcome variables, relative frequencies will be provided. Descriptive tables will be produced for baseline characteristics.

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
Actual
17/02/2016
Date of last participant enrolment
Anticipated
Actual
17/02/2016
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 7416 0
New Zealand
State/province [1] 7416 0
Auckland, Waikato

Funding & Sponsors
Funding source category [1] 292549 0
Commercial sector/Industry
Name [1] 292549 0
JenaValve Technology, Inc.
Country [1] 292549 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
JenaValve Technology, Inc.
Address
7545 Irvine Center Drive
Suite 100
Irvine, CA 92618
Country
United States of America
Secondary sponsor category [1] 291269 0
None
Name [1] 291269 0
None
Address [1] 291269 0
None
Country [1] 291269 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294026 0
Health and Disability Ethics Committee
Ethics committee address [1] 294026 0
Ministry of Health, Freyberg Building, 20 Aitken Street, PO Box 5013, Wellington 6011
Ethics committee country [1] 294026 0
New Zealand
Date submitted for ethics approval [1] 294026 0
Approval date [1] 294026 0
01/10/2015
Ethics approval number [1] 294026 0

Summary
Brief summary
The purpose of this research study is to collect information about a new treatment for severe aortic stenosis, 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. A less invasive surgical approach called TAVR (also known as TAVI) is offered to those patients who are high risk for undergoing open heart surgery to replace the aortic valve. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System, which is intended to help treat severe aortic stenosis. The JenaValve replacement valve is placed inside the aortic valve by using the JenaValve delivery system. The JenaValve replacement valve may be implanted in one of two ways: (1) transapical - where the valve is implanted through the chest wall, and (2) transfemoral – where the valve is implanted through an artery in the groin. The choice of which implant method will be used is decided by the doctor.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62186 0
Dr Mark Webster
Address 62186 0
Green Lane Cardiovascular Service
Auckland City Hospital
2 Park Road, Grafton
Auckland 1142
Country 62186 0
New Zealand
Phone 62186 0
+ 64 9 3074949
Fax 62186 0
Email 62186 0
[email protected]
Contact person for public queries
Name 62187 0
Robin Clarke
Address 62187 0
Interventional Cardiology Trial Coordinator
Auckland City Hospital
2 Park Road, Grafton
Auckland 1142
Country 62187 0
New Zealand
Phone 62187 0
+ 64 9 3074949
Fax 62187 0
Email 62187 0
[email protected]
Contact person for scientific queries
Name 62188 0
Barbara Lindsay
Address 62188 0
JVT Research and Development Corp.
7545 Irvine Center Drive, Suite 100
Irvine, CA 92618
Country 62188 0
United States of America
Phone 62188 0
+ 1 (949) 396-7500
Fax 62188 0
Email 62188 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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