Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01301625




Registration number
NCT01301625
Ethics application status
Date submitted
4/02/2011
Date registered
23/02/2011
Date last updated
7/11/2018

Titles & IDs
Public title
MitraClip System in Australia and New Zealand
Scientific title
A Prospective Single Arm Clinical Trial Evaluating the MitraClip System in Australia and New Zealand
Secondary ID [1] 0 0
Protocol #M10-001
Universal Trial Number (UTN)
Trial acronym
MitraClipANZ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mitral Regurgitation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - MitraClip Implant

MitraClip Implant - Eligible patients undergoing a MitraClip procedure in Australia and New Zealand


Treatment: Devices: MitraClip Implant
Percutaneous mitral valve repair using MitraClip implant.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)
Timepoint [2] 0 0
30 days
Primary outcome [3] 0 0
Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)
Timepoint [3] 0 0
6 months
Primary outcome [4] 0 0
Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)
Timepoint [4] 0 0
12 months
Secondary outcome [1] 0 0
Number of Participants With 0, 1, 2, and 3 MitraClip Devices Implanted
Timepoint [1] 0 0
Day 0 (On the day of procedure)
Secondary outcome [2] 0 0
Number of Participants With Acute Procedural Success Rate
Timepoint [2] 0 0
At day 0 (on the day of index procedure)
Secondary outcome [3] 0 0
Procedure Time
Timepoint [3] 0 0
At day 0 (on the day of index procedure)
Secondary outcome [4] 0 0
Device Time
Timepoint [4] 0 0
At day 0 (on the day of index procedure)
Secondary outcome [5] 0 0
Fluoroscopy Duration
Timepoint [5] 0 0
At day 0 (on the day of index procedure)
Secondary outcome [6] 0 0
Total Contrast Volume
Timepoint [6] 0 0
At day 0 (on the day of index procedure)
Secondary outcome [7] 0 0
Left Ventricle End Diastolic Volume (LVEDV)
Timepoint [7] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [8] 0 0
Left Ventricle End Diastolic Volume (LVEDV)
Timepoint [8] 0 0
At Baseline and 30 Days
Secondary outcome [9] 0 0
Left Ventricle End Diastolic Volume (LVEDV)
Timepoint [9] 0 0
At Baseline and 12 months
Secondary outcome [10] 0 0
Left Ventricular End Systolic Volume (LVESV)
Timepoint [10] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [11] 0 0
Left Ventricular End Systolic Volume (LVESV)
Timepoint [11] 0 0
At Baseline and 30 Days
Secondary outcome [12] 0 0
Left Ventricular End Systolic Volume (LVESV)
Timepoint [12] 0 0
At Baseline and 12 months
Secondary outcome [13] 0 0
Left Ventricular Ejection Fraction (LVEF)
Timepoint [13] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [14] 0 0
Left Ventricular Ejection Fraction (LVEF)
Timepoint [14] 0 0
At Baseline and 30 Days
Secondary outcome [15] 0 0
Left Ventricular Ejection Fraction (LVEF)
Timepoint [15] 0 0
At Baseline and 12 months
Secondary outcome [16] 0 0
Number of Participants With MR Severity
Timepoint [16] 0 0
Baseline
Secondary outcome [17] 0 0
Number of Participants With MR Severity
Timepoint [17] 0 0
At discharge (=7 days of index procedure)
Secondary outcome [18] 0 0
Number of Participants With MR Severity
Timepoint [18] 0 0
30 days
Secondary outcome [19] 0 0
Number of Participants With MR Severity
Timepoint [19] 0 0
6 months
Secondary outcome [20] 0 0
Number of Participants With MR Severity
Timepoint [20] 0 0
12 months
Secondary outcome [21] 0 0
Left Ventricular Internal Diameter End Diastole (LVIDd)
Timepoint [21] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [22] 0 0
Left Ventricular Internal Diameter End Diastole (LVIDd)
Timepoint [22] 0 0
At Baseline and 30 Days
Secondary outcome [23] 0 0
Left Ventricular Internal Diameter End Diastole (LVIDd)
Timepoint [23] 0 0
At Baseline and 12 Months
Secondary outcome [24] 0 0
Left Ventricular Internal Diameter End Systole (LVIDs)
Timepoint [24] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [25] 0 0
Left Ventricular Internal Diameter End Systole (LVIDs)
Timepoint [25] 0 0
At Baseline and 30 Days
Secondary outcome [26] 0 0
Left Ventricular Internal Diameter End Systole (LVIDs)
Timepoint [26] 0 0
At Baseline and 12 Months
Secondary outcome [27] 0 0
Regurgitant Volume
Timepoint [27] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [28] 0 0
Regurgitant Volume
Timepoint [28] 0 0
At Baseline and 30 Days
Secondary outcome [29] 0 0
Regurgitant Volume
Timepoint [29] 0 0
At Baseline and 12 Months
Secondary outcome [30] 0 0
Regurgitant Fraction
Timepoint [30] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [31] 0 0
Regurgitant Fraction
Timepoint [31] 0 0
At Baseline and 30 Days
Secondary outcome [32] 0 0
Regurgitant Fraction
Timepoint [32] 0 0
At Baseline and 12 Months
Secondary outcome [33] 0 0
Mitral Valve Area (MVA) by Pressure Half-time (PHT)
Timepoint [33] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [34] 0 0
Mitral Valve Area (MVA) by Pressure Half-time (PHT)
Timepoint [34] 0 0
At Baseline and 30 Days
Secondary outcome [35] 0 0
Mitral Valve Area (MVA) by Pressure Half-time (PHT)
Timepoint [35] 0 0
At Baseline and 12 Months
Secondary outcome [36] 0 0
Mitral Valve Mean Gradient
Timepoint [36] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [37] 0 0
Mitral Valve Mean Gradient
Timepoint [37] 0 0
At Baseline and 30 Days
Secondary outcome [38] 0 0
Mitral Valve Mean Gradient
Timepoint [38] 0 0
At Baseline and 12 Months
Secondary outcome [39] 0 0
Left Atrial Volume
Timepoint [39] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [40] 0 0
Left Atrial Volume
Timepoint [40] 0 0
At Baseline and 30 Days
Secondary outcome [41] 0 0
Left Atrial Volume
Timepoint [41] 0 0
At Baseline and 12 Months
Secondary outcome [42] 0 0
Six Minute Walking Distance
Timepoint [42] 0 0
Baseline
Secondary outcome [43] 0 0
Six Minute Walking Distance
Timepoint [43] 0 0
30 days
Secondary outcome [44] 0 0
Six Minute Walking Distance
Timepoint [44] 0 0
6 months
Secondary outcome [45] 0 0
Six Minute Walking Distance
Timepoint [45] 0 0
12 months
Secondary outcome [46] 0 0
Percentage of Participants With New York Heart Association (NYHA) Class
Timepoint [46] 0 0
Baseline
Secondary outcome [47] 0 0
Percentage of Participants With New York Heart Association (NYHA) Class
Timepoint [47] 0 0
30 days
Secondary outcome [48] 0 0
Percentage of Participants With New York Heart Association (NYHA) Class
Timepoint [48] 0 0
6 months
Secondary outcome [49] 0 0
Percentage of Participants With New York Heart Association (NYHA) Class
Timepoint [49] 0 0
12 months
Secondary outcome [50] 0 0
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 30 Days
Timepoint [50] 0 0
30 days
Secondary outcome [51] 0 0
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 6 Months
Timepoint [51] 0 0
6 months
Secondary outcome [52] 0 0
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 12 Months
Timepoint [52] 0 0
12 months
Secondary outcome [53] 0 0
Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)
Timepoint [53] 0 0
Baseline
Secondary outcome [54] 0 0
Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)
Timepoint [54] 0 0
30 days
Secondary outcome [55] 0 0
Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)
Timepoint [55] 0 0
6 months
Secondary outcome [56] 0 0
Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)
Timepoint [56] 0 0
12 months
Secondary outcome [57] 0 0
Number of Participants With Mitral Valve Surgery
Timepoint [57] 0 0
30 days of Post-MitraClip Procedure
Secondary outcome [58] 0 0
Number of Participants With Second Intervention to Place an Additional MitraClip Device
Timepoint [58] 0 0
Through 12 months
Secondary outcome [59] 0 0
Rate of Patients Rehospitalized
Timepoint [59] 0 0
30 days
Secondary outcome [60] 0 0
Duration of Rehospitalization
Timepoint [60] 0 0
30 days
Secondary outcome [61] 0 0
Number of Participants at Discharge Facility
Timepoint [61] 0 0
< or = 12 days
Secondary outcome [62] 0 0
Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration
Timepoint [62] 0 0
Post index procedure within 30 days
Secondary outcome [63] 0 0
Post-procedure Hospital Stay
Timepoint [63] 0 0
Post index procedure within 30 days

Eligibility
Key inclusion criteria
* Age 18 years or older.
* MR = 3+ .
* Transseptal catheterization and femoral vein access feasible.
* Placement of the MitraClip device on mitral leaflets feasible.
* Mitral valve orifice area = 4.0 cm2.
* Written informed consent obtained.
* The patient agrees to return for follow-up visits.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Need for emergency surgery, other cardiac surgery.
* Coronary artery disease (CAD), atrial fibrillation (AF), other valve disease.
* Prior mitral valve repair surgery, mechanical prosthetic valve, or ventricular assist device (VAD).
* Active endocarditis or rheumatic heart disease; leaflets degenerated from endocarditis or rheumatic disease.
* Transesophageal echocardiography (TEE) contraindicated.
* Known hypersensitivity or contraindication to trial or procedure medications which cannot be managed medically.
* Currently participating in investigational drug trial or another device trial that has not yet completed the primary endpoint or that interferes with the MitraClip System ANZ Clinical Trial.
* Pregnant or planning pregnancy within next 12 months.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2014
Sample size
Target
Accrual to date
Final
78
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
St. Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Macquarie University Hosptial - North Ryde
Recruitment hospital [3] 0 0
North Shore Private Hospital - St Leonards
Recruitment hospital [4] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [5] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [6] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2109 - North Ryde
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
4032 - Chermside
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Abbott
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Muller, MD
Address 0 0
St Vincent's Hospital - Sydney, Australia
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

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

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01301625