MitraClip System in Australia and New Zealand (MitraClipANZ)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Prospective Single Arm Clinical Trial Evaluating the MitraClip System in Australia and New Zealand|
- Echocardiographic Endpoints [ Time Frame: at 12 months after implant procedure ] [ Designated as safety issue: No ]MR Severity Grade Regurgitant Volume Regurgitant Fraction Left Ventricle End Diastolic Volume (LVEDV) Left Ventricular End Systolic Volume (LVESV) Left Ventricular End Diastolic Dimension (LVIDd) Left Ventricular End Systolic Dimension (LVIDs) LV Ejection Fraction (LVEF) Mitral Valve Area Mitral Valve Gradient Left Atrial Volumes
- Clinical Endpoints [ Time Frame: at 12 months after procedure ] [ Designated as safety issue: Yes ]Mortality NYHA Functional Class Six-Minute Walk Test (6MWT) distance QOL Assessment (Minnesota Living with Heart Failure Questionnaire) Mitral valve surgery, including reason for and type of surgery Second MitraClip device intervention, including reason for intervention Re-hospitalizations Reason for rehospitalization (i.e., heart failure, other cardiac, non-cardiac) Number of rehospitalizations Number of days rehospitalized
|Study Start Date:||November 2011|
|Study Completion Date:||September 2014|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Eligible patients undergoing a MitraClip procedure in Australia and New Zealand
Device: MitraClip Implant
Percutaneous mitral valve repair using MitraClip implant.
The MitraClip System ANZ Clinical Trial is a prospective, observational, single arm, multicenter trial to evaluate the MitraClip device for the treatment of mitral regurgitation (MR). Patients will be enrolled at up to 15 investigational sites throughout Australia and New Zealand. Up to 150 patients will be enrolled. Patients will be considered enrolled when local or general anesthesia is administered for the MitraClip procedure. Patients will be followed at discharge, 30 days, 6 months, 12 months and 24 months.
Investigational sites will recruit consecutive patients who meet trial enrollment criteria. Until enrollment in the MitraClip System ANZ Clinical Trial is closed, all patients who undergo a procedure for placement of a MitraClip device at an investigational site should be enrolled in the MitraClip System ANZ Clinical Trial.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301625
|Australia, New South Wales|
|St. Vincent's Hospital Sydney|
|Darlinghurst, New South Wales, Australia, 2010|
|Macquarie University Hosptial|
|North Ryde, New South Wales, Australia, 2109|
|North Shore Private Hospital|
|St Leonards, New South Wales, Australia, 2065|
|The Prince Charles Hospital|
|Chermside, Queensland, Australia, 4032|
|Australia, South Australia|
|Flinders Medical Centre|
|Bedford Park, South Australia, Australia, 5042|
|Australia, Western Australia|
|Sir Charles Gairdner Hospital|
|Nedlands, Western Australia, Australia, 6009|
|Principal Investigator:||David Muller, MD||St Vincent's Hospital, Sydney, Australia|
|Principal Investigator:||Jurgen Passage, FRACs||Sir Charles Gairdner Hospital, Perth, Australia|