MitraClip System in Australia and New Zealand (MitraClipANZ)
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ClinicalTrials.gov Identifier: NCT01301625 |
Recruitment Status
:
Terminated
First Posted
: February 23, 2011
Last Update Posted
: November 3, 2015
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Condition or disease | Intervention/treatment |
---|---|
Mitral Regurgitation | Device: 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.
Study Type : | Observational |
Actual Enrollment : | 78 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Prospective Single Arm Clinical Trial Evaluating the MitraClip System in Australia and New Zealand |
Study Start Date : | November 2011 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | September 2014 |
Group/Cohort | Intervention/treatment |
---|---|
MitraClip Implant
Eligible patients undergoing a MitraClip procedure in Australia and New Zealand
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Device: MitraClip Implant
Percutaneous mitral valve repair using MitraClip implant.
Other Names:
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- Echocardiographic Endpoints [ Time Frame: at 12 months after implant procedure ]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 ]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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 | |
Australia, Queensland | |
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 |
Publications:
Responsible Party: | Evalve |
ClinicalTrials.gov Identifier: | NCT01301625 History of Changes |
Other Study ID Numbers: |
Protocol #M10-001 |
First Posted: | February 23, 2011 Key Record Dates |
Last Update Posted: | November 3, 2015 |
Last Verified: | November 2015 |
Keywords provided by Evalve:
MitraClip mitral regurgitation (MR) mitral valve insufficiency percutaneous mitral valve repair congestive heart failure |
Additional relevant MeSH terms:
Mitral Valve Insufficiency Heart Valve Diseases Heart Diseases Cardiovascular Diseases |