Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000718448
Ethics application status
Approved
Date submitted
19/04/2016
Date registered
30/05/2016
Date last updated
7/06/2017
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 regurgitation (AR).
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 Regurgitation (AR)
Secondary ID [1] 289042 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Regurgitation 298461 0
Condition category
Condition code
Cardiovascular 298560 298560 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] 294526 0
Treatment: Devices
Comparator / control treatment
Nil- single-arm study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298048 0
All-cause mortality (adjudicated)
Timepoint [1] 298048 0
30 days post-index procedure
Secondary outcome [1] 323010 0
Event rate of VARC-2 individual safety endpoints, including:
- All-cause mortality (assessed by review of medical records)
Timepoint [1] 323010 0
At 1 month, 6 months, 1 year, and 2 years post-index procedure.
Secondary outcome [2] 323011 0
- Myocardial infarction (assessed by review of medical records)
Timepoint [2] 323011 0
At 1 month, 6 months, 1 year, and 2 years post-index procedure.
Secondary outcome [3] 323012 0
- Neurologic complications- all cause stroke and transient ischemic attack (TIA) (assessed by review of medical records)
Timepoint [3] 323012 0
At 1 month, 6 months, 1 year, and 2 years post-index procedure.
Secondary outcome [4] 323013 0
- Bleeding complications (assessed by review of medical records)
Timepoint [4] 323013 0
At 1 month, 6 months, 1 year, and 2 years post-index procedure.
Secondary outcome [5] 323565 0
- Acute kidney injury (AKIN classification) (assessed by review of medical records)
Timepoint [5] 323565 0
within 7 days post-index procedure.
Secondary outcome [6] 323566 0
- Vascular complications (Major, minor, closure device failure) (assessed by review of medical records)
Timepoint [6] 323566 0
At 1 month, 6 months, 1 year, and 2 years post-index procedure.
Secondary outcome [7] 323567 0
- Conduction disturbances and arrhythmias (assessed by review of medical records)
Timepoint [7] 323567 0
At 1 month, 6 months, 1 year, and 2 years post-index procedure.
Secondary outcome [8] 323568 0
- TAVR-related complications (assessed by review of medical records)
Timepoint [8] 323568 0
At 1 month, 6 months, 1 year, and 2 years post-index procedure.
Secondary outcome [9] 323569 0
Functional classification assessed using the New York Heart Association (NYHA) functional class.
Timepoint [9] 323569 0
At 1 month, 6 months, 1 year, and 2 years post-index procedure, as compared to baseline.
Secondary outcome [10] 323570 0
Clinical outcome assessed using the 6 Minute Walk Test (6MWT).
Timepoint [10] 323570 0
At 6 months, 1 year, and 2 years post-index procedure, as compared to baseline.
Secondary outcome [11] 323571 0
Clinical outcome assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Timepoint [11] 323571 0
At 1 year and 2 years post-index procedure, as compared to baseline.

Eligibility
Key inclusion criteria
1. Patient with severe aortic regurgitation (AR) assessed by echocardiography
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/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
Actual
19/04/2016
Date of last participant enrolment
Anticipated
Actual
19/04/2016
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 7830 0
New Zealand
State/province [1] 7830 0
Waikato

Funding & Sponsors
Funding source category [1] 293414 0
Commercial sector/Industry
Name [1] 293414 0
JenaValve Technology, Inc.
Country [1] 293414 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] 292240 0
None
Name [1] 292240 0
None
Address [1] 292240 0
None
Country [1] 292240 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294862 0
Health and Disability Ethics Committee
Ethics committee address [1] 294862 0
Ministry of Health, Freyberg Building, 20 Aitken Street, PO Box 5013, Wellington 6011
Ethics committee country [1] 294862 0
New Zealand
Date submitted for ethics approval [1] 294862 0
Approval date [1] 294862 0
20/10/2015
Ethics approval number [1] 294862 0

Summary
Brief summary
The purpose of this research study is to collect information about a new treatment for severe aortic regurgitation, which affects the aortic valve in the heart. Aortic regurgitation is a condition where the heart’s aortic valve does not close tightly and allows some blood to leak back into the heart’s main pumping chamber – the left ventricle. Symptoms of aortic regurgitation may include fatigue and shortness of breath. In New Zealand the options available for treating severe aortic regurgitation include surgical aortic valve replacement or treatment with medications. This investigational device has been designed to enable the treatment of aortic regurgitation in a TAVI procedure. Your doctors have determined that you need a new aortic heart valve. TAVI is offered to those patients who are at high risk for undergoing open heart surgery to replace the aortic valve.. It has been determined however that you may meet the criteria to have your valve replaced with the JenaValve Pericardial TAVR System as part of this research study. 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 59078 0
Dr Sanjeevan Pasupati
Address 59078 0
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country 59078 0
New Zealand
Phone 59078 0
+6478398899
Fax 59078 0
+6478398639
Email 59078 0
[email protected]
Contact person for public queries
Name 59079 0
Mrs Kirsty Abercrombie
Address 59079 0
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country 59079 0
New Zealand
Phone 59079 0
+6478397136
Fax 59079 0
Email 59079 0
[email protected]
Contact person for scientific queries
Name 59080 0
Ms Barbara Lindsay
Address 59080 0
JenaValve Technology, Inc.
7545 Irvine Center Drive, Suite 100
Irvine, CA 92618
Country 59080 0
United States of America
Phone 59080 0
+ 1 (949) 396-7500
Fax 59080 0
Email 59080 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
No additional documents have been identified.