MitraClip System in Australia and New Zealand (MitraClipANZ)
This study has been terminated.
Sponsor:
Evalve
Collaborator:
Abbott
Information provided by (Responsible Party):
Evalve
ClinicalTrials.gov Identifier:
NCT01301625
First received: February 4, 2011
Last updated: November 2, 2015
Last verified: November 2015
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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 |
Further study details as provided by Evalve:
Primary Outcome Measures:
- 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
| Enrollment: | 78 |
| Study Start Date: | November 2011 |
| Study Completion Date: | September 2014 |
| Primary Completion Date: | September 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 (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Consecutive patients eligible to receive the MitraClip implant at the designated investigational sites in Australia and New Zealand.
Criteria
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 Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301625
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301625
Locations
| 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 | |
Sponsors and Collaborators
Evalve
Abbott
Investigators
| Principal Investigator: | David Muller, MD | St Vincent's Hospital, Sydney, Australia |
| 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: | November 2, 2015 |
| 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 Heart Valve Diseases Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on September 23, 2016