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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
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Evalve

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment
Mitral Regurgitation Device: MitraClip Implant

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.


Study Design
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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
Groups and Cohorts
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Group/Cohort Intervention/treatment
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:
  • MitraClip System
  • MitraClip Delivery System
  • Steerable Guide Catheter


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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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
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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