Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000020785
Ethics application status
Approved
Date submitted
3/01/2013
Date registered
8/01/2013
Date last updated
8/01/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The MitraClip System ANZ Clinical Trial is a prospective single arm clinical trial for men and women with significant, chronic mitral regurgitation to gather real-world clinical and health-economic outcome data to support the long-term safety, efficacy and economic value of the MitraClip System for treating mitral regurgitation
Scientific title
A Prospective Single Arm Clinical Trial Evaluating the MitraClip (Registered Trademark) System in Australia and New Zealand for Men and Women with Significant, Chronic Mitral Regurgitation
Secondary ID [1] 281723 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mitral Regurgitation
 288021 0
Condition category
Condition code
Cardiovascular 288398 288398 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The MitraClip System consists of a delivery catheter and an implantable Clip. The Clip is made of metal and is covered with polyester fabric. The Clip is attached to the end of a delivery catheter, which is a thin flexible tube that is used to insert and position the Clip on the mitral valve. The delivery catheter guides the Clip into place so that it can be attached to the leaflets of the mitral valve. Once the Clip is in place on the mitral valve, the delivery catheter is removed. The procedure to place the Clip will take around 3 to 4 hours and will be done under general anesthesia in the hospital. The procedure will be performed in the cardiac catheterization laboratory. This type of catheterization procedure usually requires an overnight stay in the hospital and around 24 hours to recover. The MitraClip procedure is performed using TEE and x-rays (called fluoroscopy). Participants may be required to limit physical activity for 30 days or longer after the procedure as instructed by the Trial doctor.

Participants will undergo the MitraClip procedure after their doctor has carefully evaluated their MR using ultrasound and if necessary, angiography. To introduce the MitraClip System, the doctor will insert the delivery catheter into the femoral vein in the groin. The delivery catheter will then be advanced along the vein until it enters the heart. A transseptal approach is used to gain access to the mitral valve. This is done by crossing from the right to left side (i.e., the name transseptal means to cross the septum) of the heart through a small opening. This small opening is present in about 1 out of 5 people and in others a commercially available catheter is used to create a small opening by puncturing the septum. In general, this opening will seal up on its own after the procedure. The delivery catheter will then be advanced through the small opening. The doctor will position the Clip, which is at the end of the delivery catheter, to a location in the middle of the mitral valve leaflets.

The Clip has two arms that are then opened to grasp the bottom of the two valve leaflets. Inside each Clip arm is a gripper. Once the arms have grasped the bottom of the leaflets, the grippers are then lowered onto the top of the leaflets, toward the arms. This causes each leaflet to be sandwiched between the arms and the grippers of the Clip. The Clip will be closed to pull the two leaflets together and locked in place. This secures the leaflets into the Clip and holds the two leaflets of the valve together at the point of the Clip. Finally, the Clip is separated from the delivery catheter. The valve will now open with two openings instead of one. At the end of the procedure, the delivery catheter will be removed and the Clip will be left in the body to help the mitral valve leaflets close sufficiently. It is possible that two Clips may be required to sufficiently reduce the mitral regurgitation. In order to place another Clip, if needed, the first delivery catheter will be removed and a new delivery catheter with the other Clip will be passed into the left side of the heart by the same approach as described above. The other Clip will then be placed adjacent to the first Clip in the same manner as previously described. It is also possible that if participants only receive one Clip during the initial procedure, a second Clip may be placed at a later date if required.

Participants will be observed for 2 years as part of this clinical trial.
Intervention code [1] 286261 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288568 0
Echocardiographic Endpoint: MR Severity Grade
Timepoint [1] 288568 0
at 12 months after implant procedure
Primary outcome [2] 288569 0
Echocardiographic Endpoint: Regurgitant Volume
Timepoint [2] 288569 0
at 12 months after implant procedure
Primary outcome [3] 288584 0
Echocardiographic Endpoint: Left Ventricle End Diastolic Volume (LVEDV)
Timepoint [3] 288584 0
at 12 months after implant procedure
Secondary outcome [1] 300480 0
Primary Outcome Echocardiographic Endpoint: Left Ventricular End Systolic Volume (LVESV)
Timepoint [1] 300480 0
at 12 months after implant procedure
Secondary outcome [2] 300521 0
Primary Outcome Echocardiographic Endpoint: Left Ventricular End Diastolic Dimension (LVIDd)
Timepoint [2] 300521 0
at 12 months after implant procedure
Secondary outcome [3] 300522 0
Primary Outcome Echocardiographic Endpoint: Left Ventricular End Systolic Dimension (LVIDs)
Timepoint [3] 300522 0
at 12 months after implant procedure
Secondary outcome [4] 300523 0
Primary Outcome Echocardiographic Endpoint: LV Ejection Fraction (LVEF)
Timepoint [4] 300523 0
at 12 months after implant procedure
Secondary outcome [5] 300524 0
Primary Outcome Echocardiographic Endpoint: Mitral Valve Area
Timepoint [5] 300524 0
at 12 months after implant procedure
Secondary outcome [6] 300525 0
Primary Outcome Echocardiographic Endpoint: Mitral Valve Gradient
Timepoint [6] 300525 0
at 12 months after implant procedure
Secondary outcome [7] 300526 0
Primary Outcome Echocardiographic Endpoint: Left Atrial Volumes
Timepoint [7] 300526 0
at 12 months after implant procedure
Secondary outcome [8] 300527 0
Primary Outcome Echocardiographic Endpoint: Regurgitant Fraction
Timepoint [8] 300527 0
at 12 months after implant procedure
Secondary outcome [9] 300528 0
Primary Outcome Clinical Endpoint: Mortality
Timepoint [9] 300528 0
at 12 months after procedure
Secondary outcome [10] 300529 0
Primary Outcome Clinical Endpoint: NYHA Functional Class (assessed by The New York Heart Association (NYHA) Functional Classification)
Timepoint [10] 300529 0
at 12 months after procedure
Secondary outcome [11] 300530 0
Primary Outcome Clinical Endpoint: Six-Minute Walk Test (6MWT) distance (Measured by how long participants can walk in six minutes, which will provide information on their ability to exercise.)
Timepoint [11] 300530 0
at 12 months after procedure
Secondary outcome [12] 300531 0
Primary Outcome Clinical Endpoint: QOL Assessment (Minnesota Living with Heart Failure Questionnaire which contains questions about how the participants health affects their daily life.)
Timepoint [12] 300531 0
at 12 months after procedure
Secondary outcome [13] 300532 0
Primary Outcome Clinical Endpoint: Mitral valve surgery, including reason for and type of surgery
Timepoint [13] 300532 0
at 12 months after procedure
Secondary outcome [14] 300533 0
Primary Outcome Clinical Endpoint: Second MitraClip device intervention, including reason for intervention
Timepoint [14] 300533 0
at 12 months after procedure
Secondary outcome [15] 300534 0
Primary Outcome Clinical Endpoint: Re-hospitalizations:
Reason for rehospitalization (i.e., heart failure, other cardiac, non-cardiac)
Number of rehospitalizations Number of days rehospitalized
Timepoint [15] 300534 0
at 12 months after procedure

Eligibility
Key inclusion criteria
1. Age 18 years or older.
2. Significant, chronic MR (greater than or equal to 3+) by echocardiography.
3. In the judgment of the Investigator, transseptal catheterization and femoral vein access are feasible.
4. In the judgment of the Investigator, placement of the MitraClip device on the mitral leaflets is feasible.
5. Mitral valve orifice area greater than or equal to 4.0 cm2.
6. The patient or the patient’s legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the institution’s Human Research Ethics Committee (HREC) of the respective clinical site.
7. The patient agrees to return for all required post-procedure follow-up visits.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have need for emergency surgery for any reason or need for any other cardiac surgery including surgery for coronary artery disease, atrial fibrillation, pulmonic, aortic or tricuspid disease.
2. Have undergone prior mitral valve repair surgery or have any currently implanted mechanical prosthetic valve or currently implanted ventricular assist device (VAD).
3. Have active endocarditis or active rheumatic heart disease or leaflets degenerated from either endocarditis or rheumatic disease (i.e., noncompliant, perforated).
4. Transesophageal echocardiography (TEE) is contraindicated.
5. Has a known hypersensitivity or contraindication to trial or procedure medications which cannot be adequately managed medically.
6. Currently participating in an investigational drug trial or another device trial that has not yet completed the primary endpoint or that otherwise clinically interferes with the MitraClip System ANZ Clinical Trial data collection. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.)
7. Pregnant or planning pregnancy within next 12 months.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/11/2011
Date of last participant enrolment
Anticipated
1/12/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 350 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 351 0
The Prince Charles Hospital - Chermside
Recruitment hospital [3] 352 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst

Funding & Sponsors
Funding source category [1] 286510 0
Commercial sector/Industry
Name [1] 286510 0
Evalve, Inc.
A subsidiary of Abbott Vascular Inc.
Country [1] 286510 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Evalve, Inc. A subsidiary of Abbott Vascular Inc.
Address
4045 Campbell Ave
Menlo Park, CA 94025
Country
United States of America
Secondary sponsor category [1] 285299 0
None
Name [1] 285299 0
Address [1] 285299 0
Country [1] 285299 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288585 0
Sir Charles Gairdner Group Human Research Ethics Committee
Ethics committee address [1] 288585 0
Ethics committee country [1] 288585 0
Australia
Date submitted for ethics approval [1] 288585 0
Approval date [1] 288585 0
Ethics approval number [1] 288585 0
Ethics committee name [2] 288595 0
The Prince Charles Hospital Metro North Health Service District Human Research Ethics Committee
Ethics committee address [2] 288595 0
Ethics committee country [2] 288595 0
Australia
Date submitted for ethics approval [2] 288595 0
Approval date [2] 288595 0
23/11/2011
Ethics approval number [2] 288595 0
Ethics committee name [3] 288596 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [3] 288596 0
Ethics committee country [3] 288596 0
Australia
Date submitted for ethics approval [3] 288596 0
Approval date [3] 288596 0
17/05/2011
Ethics approval number [3] 288596 0

Summary
Brief summary
The primary objective of the MitraClip System ANZ Clinical Trial is to gather real-world clinical and health-economic outcome data to support the long-term safety, efficacy and economic value of the MitraClip System in the continuum of therapies for treating MR. Specifically, the following clinical and economic data will be collected: New York Heart Association (NYHA) Functional Class, Six-Minute Walk Test (6MWT) distance, quality of life (QOL) information, echocardiographic measures of left ventricular size and function, and data associated with the index hospitalization, rehospitalizations, concomitant medications and discharge facility to support the MitraClip System economic analysis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36806 0
A/Prof David Muller
Address 36806 0
Cardiology Department
St. Vincent's Hospital
390 Victoria Street
Darlinghurst, NSW 2010
Country 36806 0
Australia
Phone 36806 0
61283822775
Fax 36806 0
Email 36806 0
[email protected]
Contact person for public queries
Name 36807 0
Ms Barathi Sethuraman, PhD
Address 36807 0
Abbott Vascular Structural Heart
4045 Campbell Ave
Menlo Park, CA 94025
Country 36807 0
United States of America
Phone 36807 0
1-650-833-1638
Fax 36807 0
Email 36807 0
[email protected]
Contact person for scientific queries
Name 36808 0
Ms Barathi Sethuraman, PhD
Address 36808 0
Abbott Vascular Structural Heart
4045 Campbell Ave
Menlo Park, CA 94025
Country 36808 0
United States of America
Phone 36808 0
1-650-833-1638
Fax 36808 0
Email 36808 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

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