Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
TERMINATED
Total Enrollment
78 participants
Study Classification
OBSERVATIONAL
Study Start Date
2011-11-30
Study Completion Date
2014-09-30
Brief Summary
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The primary objective of the MitraClip System Australia and New Zealand (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.
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Detailed Description
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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.
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.
Conditions
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Mitral Regurgitation
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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MitraClip Implant
Eligible patients undergoing a MitraClip procedure in Australia and New Zealand
MitraClip Implant
Intervention Type
DEVICE
Percutaneous mitral valve repair using MitraClip implant.
Interventions
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MitraClip Implant
Percutaneous mitral valve repair using MitraClip implant.
Intervention Type
DEVICE
Other Intervention Names
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MitraClip System
MitraClip Delivery System
Steerable Guide Catheter
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Abbott
INDUSTRY
Sponsor Role
collaborator
Abbott Medical Devices
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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David Muller, MD
Role: PRINCIPAL_INVESTIGATOR
St Vincent's Hospital - Sydney, Australia
Jurgen Passage, FRACs
Role: PRINCIPAL_INVESTIGATOR
Sir Charles Gairdner Hospital, Perth, Australia
Locations
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St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Site Status
Macquarie University Hosptial
North Ryde, New South Wales, Australia
Site Status
North Shore Private Hospital
St Leonards, New South Wales, Australia
Site Status
The Prince Charles Hospital
Chermside, Queensland, Australia
Site Status
Flinders Medical Centre
Bedford Park, South Australia, Australia
Site Status
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Site Status
Countries
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Australia
References
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Mauri L, Garg P, Massaro JM, Foster E, Glower D, Mehoudar P, Powell F, Komtebedde J, McDermott E, Feldman T. The EVEREST II Trial: design and rationale for a randomized study of the evalve mitraclip system compared with mitral valve surgery for mitral regurgitation. Am Heart J. 2010 Jul;160(1):23-9. doi: 10.1016/j.ahj.2010.04.009.
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Ussia GP, Barbanti M, Tamburino C. Feasibility of percutaneous transcatheter mitral valve repair with the MitraClip system using conscious sedation. Catheter Cardiovasc Interv. 2010 Jun 1;75(7):1137-40. doi: 10.1002/ccd.22415.
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Geidel S, Ostermeyer J, Lass M, Schmoeckel M. Complex surgical valve repair after failed percutaneous mitral intervention using the MitraClip device. Ann Thorac Surg. 2010 Jul;90(1):277-9. doi: 10.1016/j.athoracsur.2009.12.048.
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Conradi L, Treede H, Franzen O, Seiffert M, Baldus S, Schirmer J, Meinertz T, Reichenspurner H. Impact of MitraClip therapy on secondary mitral valve surgery in patients at high surgical risk. Eur J Cardiothorac Surg. 2011 Dec;40(6):1521-6. doi: 10.1016/j.ejcts.2011.03.007. Epub 2011 Apr 15.
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Protocol #M10-001
Identifier Type: -
Identifier Source: org_study_id
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