MitraClip System in Australia and New Zealand (MitraClipANZ)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Mitral Regurgitation |
Device: MitraClip Implant |
| Study Type: | Observational |
| 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
| Estimated Enrollment: | 150 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
MitraClip Implant
Eligible patients undergoing a MitraClip procedure in Australia and New Zealand
|
Device: MitraClip Implant
Percutaneous mitral valve repair using MitraClip implant.
Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Consecutive patients eligible to receive the MitraClip implant at the designated investigational sites in Australia and New Zealand.
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01301625
| Contact: Jasmine Wilson | 1-650-833-4435 | jasmine.wilson@abbott.com |
| Australia, New South Wales | |
| St. Vincent's Hospital Sydney | Recruiting |
| Darlinghurst, New South Wales, Australia, 2010 | |
| Contact: David Muller, MD 61 2 8382 2775 dmuller@stvincents.com.au | |
| Principal Investigator: David Muller, MD | |
| Macquarie University Hosptial | Recruiting |
| North Ryde, New South Wales, Australia, 2109 | |
| Contact: Martin Ng, M.D. 61 2 9519 6875 mkcng@med.usyd.edu.au | |
| Principal Investigator: Martin Ng, M.D. | |
| North Shore Private Hospital | Recruiting |
| St Leonards, New South Wales, Australia, 2065 | |
| Contact: Ravi Bhindi, M.D. 61 2 9926 8677 ravinay.bhindi@sydney.edu.au | |
| Principal Investigator: Ravi Bhindi, M.D. | |
| Australia, Queensland | |
| The Prince Charles Hospital | Recruiting |
| Chermside, Queensland, Australia, 4032 | |
| Contact: Darren Walters, MD 61 7 3139 5906 Darren_Walters@health.qld.gov.au | |
| Principal Investigator: Darren Walters, MD | |
| Australia, South Australia | |
| Flinders Medical Centre | Not yet recruiting |
| Bedford Park, South Australia, Australia, 5042 | |
| Contact: Malcolm Fawcett 61 8 8204 4440 malcolm.fawcet@sahmri.com | |
| Principal Investigator: Ajay Sinhal, MD | |
| Australia, Western Australia | |
| Sir Charles Gairdner Hospital | Recruiting |
| Nedlands, Western Australia, Australia, 6009 | |
| Contact: Eric Yamen, MD 61 8 9346 2133 eric.yamen@health.wa.gov.au | |
| Principal Investigator: Eric Yamen, MD | |
| Principal Investigator: | David Muller, MD | St Vincent's Hospital, Sydney, Australia | |
| Study Director: | Barathi Sethuraman, PhD | Abbott Vascular, Menlo Park, CA | |
| Principal Investigator: | Jurgen Passage, FRACs | Sir Charles Gairdner Hospital, Perth, Australia |
More Information
Publications:
| Responsible Party: | Evalve |
| ClinicalTrials.gov Identifier: | NCT01301625 History of Changes |
| Other Study ID Numbers: | Protocol #M10-001 |
| Study First Received: | February 4, 2011 |
| Last Updated: | March 5, 2014 |
| Health Authority: | Australia: Human Research Ethics Committee Australia: National Health and Medical Research Council Australia: Department of Health and Ageing Therapeutic Goods Administration New Zealand: Medsafe New Zealand: Institutional Review Board |
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 Cardiovascular Diseases Heart Diseases Heart Valve Diseases |
ClinicalTrials.gov processed this record on March 01, 2015