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 registered on ANZCTR


Registration number
ACTRN12618000103268p
Ethics application status
Not yet submitted
Date submitted
13/01/2018
Date registered
23/01/2018
Date last updated
23/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study of the CardiAQ-Edwards ™ Transcatheter Mitral Valve (TMV) System for patients requiring mitral valve replacement
Scientific title
Early Feasibility Study of the CardiAQ-Edwards ™ Transcatheter Mitral Valve (TMV) System for patients with clinically significant, symptomatic mitral regurgitation requiring either mitral valve repair or replacement who are at high surgical risk as assessed by the Heart Team.
Secondary ID [1] 293675 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mitral Regurgitation 305974 0
Condition category
Condition code
Cardiovascular 305168 305168 0 0
Other cardiovascular diseases
Surgery 305169 305169 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The CardiAQ™ Transcatheter Mitral Valve System (TMVI) with the Transseptal Delivery Systems is intended to be used with patients suffering from moderate to severe mitral regurgitation (=3 +) requiring mitral valve replacement and whose native mitral annulus (major axis) dimension is appropriate for the available valve sizes and also been determined by a Cardiac Surgeon to be high risk or extreme risk for open heart surgery.
The TMVI System is intended to offer permanent valve implantation using a catheter-based delivery system option for patients experiencing mitral valve regurgitation, and who are high risk or extreme risk for surgical treatment. The System is intended primarily for patients with secondary or functional mitral regurgitation, but could also be used to treat patients with primary or organic mitral regurgitation if their anatomy is suitable. The System is not intended for patients with a pre-existing (prosthetic) device in the mitral valve space.

The intended users of the TMVI System are Interventional Cardiologists with structural heart disease experience, and Cardiac Surgeons with interventional skills. Investigators performing the implant procedure will receive device training via bench-top simulation and animal lab procedures prior to patient enrollment. Prior to device training, a presentation outlining each procedural step with an in-depth discussion on the unique aspects of the system and procedure will be conducted. The Investigator formal training will be performed by the Study Sponsor prior to patient enrollment at the study center.

Echocardiographers/Radiologists/Cardiologists appointed by the Site Principal Investigator must undergo training prior to patient enrollment. This training includes a device description and discussion of the protocol. Following this training and before starting the study, at the discretion of the Echo Core Lab director, the appointed Echocardiographer may be requested to send to the Echo Core Lab at least one sample image examination for quality assessment. This sample has to be a generic exam, representative of the site’s standard quality, to be evaluated by the Echo Core Lab. This examination will allow for feedback and therefore corrections to acquisition techniques before the start of the study. The documentation for this training (participants, number of sessions, outcomes) will be held by the Investigator in the Site Study Binder and by the Sponsor.

Training will be documented on a training record provided by the Study Sponsor, which the trainee must sign and date. The training of study support staff must be completed and documented according to the specific study tasks delegated to them by the Investigator.

The System is intended for use in a catheterization lab, surgical suite, or hybrid suite. The procedure will be performed at hospital facility that has a post-cardiac intensive care unit .
The Transseptal Delivery System is used to obtain transseptal access for delivery, positioning, and deployment of the valve TMV. It consists of the main delivery unit with a 107 cm working length, a 33 Fr OD ePTFE capsule for housing and securing the TMV and a 24 Fr integrated introducer sheath to maintain hemostasis at the femoral incision throughout the procedure. The access site is either a percutaneous insertion or a surgical cut down at either the left or right femoral or iliac vein to gain access to the right atrium. A transseptal puncture is made between the right and left atria and a 0.035 inch guidewire is used to gain access to the left ventricle via the left atrium.

The atrial septum is dilated using an off the shelf balloon catheter. A second balloon is inflated and tracked between the LVOT and the left atrium to confirm the wire path is free from mitral chordal entanglement. The delivery system is inserted through the femoral vein over the guidewire. With the distal tip of the delivery system in the left atrium, the delivery system capsule is flexed into location through rotation of the flex wheel.
Once in position, the retraction wheel is rotated to begin the TMV deployment process. Once the left ventricular anchors are fully expanded and the native mitral leaflets are captured, the TMV is released from the delivery system. The tapered tip is pulled back through the TMV. The delivery system is unflexed and retracted to free the attachment mechanisms from the TMV. Once free of the TMV, the attachment mechanisms are re-sheathed and the delivery system is pulled proximally in order to be removed from the body.

The Bioprosthesis operates similarly to a healthy native mitral valve and prevents backflow from the left ventricle into the left atrium during systole. It is designed to conform to the natural shape of the annulus in three dimensions to ensure that the systolic load during closing is distributed evenly. The Bioprosthesis anchoring system extends between the chordae tendinae of the subvalvular apparatus to engage and capture the free-edge of the native mitral leaflets (anterior and posterior). This helps to dissipate the systolic load, minimize paravalvular leak, and reduce the risk of left ventricular outflow tract obstruction or systolic anterior leaflet motion.
The TMVI system is intended to offer permanent valve replacement for all participants.
Intervention code [1] 299941 0
Treatment: Surgery
Intervention code [2] 300075 0
Treatment: Devices
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304426 0
Safety assessed by freedom from device or procedure-related adverse events:
Freedom from death at 30 days from the implant procedure
Timepoint [1] 304426 0
30 days from the implant procedure
Primary outcome [2] 304492 0
Safety assessed by freedom from device or procedure-related adverse events:
Freedom from Major Adverse Cardiac and Cerebrovascular Events (MACCE; defined as death, MI, stroke and renal failure), severe bleeding and re-intervention at 30 days, from the implant procedure
Timepoint [2] 304492 0
30 days from the implant procedure
Secondary outcome [1] 341918 0
NYHA functional class: Number of patients with improvement in NYHA class from baseline in symptoms
Functional class will be evaluated during follow-ups using New York Heart Association Functional Classification.
Timepoint [1] 341918 0
30 days, 3 months, 6 months, 12 months and annually for five years, from baseline in symptoms.
Secondary outcome [2] 342132 0
American Thoracic Surgery Six Minute Walk Test: Increase in distance (m) from baseline performance
Timepoint [2] 342132 0
30 days, 3 Months ,6 Months, 12 Months, annual for five years, compared to baseline performance
Secondary outcome [3] 342133 0
Reduction in MR grade: Number of patients with reduction in mitral regurgitation grade from baseline assessed via Transesophageal Echocardiography
Timepoint [3] 342133 0
30 days, 3 Months ,6 Months, 12 Months, annual for five years, compared to baseline

Eligibility
Key inclusion criteria
•Clinically significant, symptomatic mitral regurgitation
•High risk for open-heart surgery
•Meets anatomical criteria
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
•Unsuitable anatomy
•Patient is inoperable

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
Not yet recruiting
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 outside Australia
Country [1] 9486 0
New Zealand
State/province [1] 9486 0
Waikato

Funding & Sponsors
Funding source category [1] 298294 0
Commercial sector/Industry
Name [1] 298294 0
Edwards Lifesciences, LLT
Address [1] 298294 0
Level 7, 36 Brandon Street
Wellington 6011 NZ
Country [1] 298294 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Edwards Lifesciences, LLT
Address
Level 7, 36 Brandon Street
Wellington 6011 NZ
Country
New Zealand
Secondary sponsor category [1] 297409 0
None
Name [1] 297409 0
Address [1] 297409 0
Country [1] 297409 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 299294 0
Ethics committee address [1] 299294 0
Ethics committee country [1] 299294 0
Date submitted for ethics approval [1] 299294 0
20/02/2018
Approval date [1] 299294 0
Ethics approval number [1] 299294 0

Summary
Brief summary
The objectives of this early feasibility study are to:
• Evaluate the safety and function of the CardiAQ-Edwards™ Transcatheter Mitral Valve System
• Provide guidance for future clinical study designs utilizing the CardiAQ-Edwards™ Transcatheter Mitral Valve System
• Provide guidance for future investigational device development efforts
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79942 0
Dr Rajesh Nair
Address 79942 0
Waikato District Health Board, Waikato Hospital
Cardiology Department
Private Bag 3200
Pembroke Street, Hamilton West
Hamilton 3204
Country 79942 0
New Zealand
Phone 79942 0
+64 7 8398899 xt 98566
Fax 79942 0
Email 79942 0
rajesh.nair@waikatodhb.health.nz
Contact person for public queries
Name 79943 0
Mrs Liz Low
Address 79943 0
Cardiology Clinical Trials Unit
14 Horne Street
Hamilton West
Hamilton 3204
Country 79943 0
New Zealand
Phone 79943 0
+64 7 839 7136
Fax 79943 0
Email 79943 0
lizl@cardiotrialswaikato.org.nz
Contact person for scientific queries
Name 79944 0
Mrs Deborah Deutsch
Address 79944 0
Edwards Lifesciences
One Edwards Way
Irvine, CA 92614
Country 79944 0
United States of America
Phone 79944 0
+1 (949) 756-4213
Fax 79944 0
Email 79944 0
deborah_deutsch@edwards.com

No data has been provided for results reporting
Summary results
Not applicable