MitraClip System in Australia and New Zealand (MitraClipANZ)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Evalve
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Evalve
ClinicalTrials.gov Identifier:
NCT01301625
First received: February 4, 2011
Last updated: March 5, 2014
Last verified: March 2014
  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


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:
  • MitraClip System
  • MitraClip Delivery System
  • Steerable Guide Catheter

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
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

Contacts
Contact: Jasmine Wilson 1-650-833-4435 jasmine.wilson@abbott.com

Locations
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         
Sponsors and Collaborators
Evalve
Abbott
Investigators
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
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014