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MitraClip System in Australia and New Zealand

NCT01301625 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 78

Last updated 2018-11-07

Study results available
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Summary

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.

Conditions

  • Mitral Regurgitation

Interventions

DEVICE

MitraClip Implant

Percutaneous mitral valve repair using MitraClip implant.

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • David Muller, MD · St Vincent's Hospital - Sydney, Australia

  • Jurgen Passage, FRACs · Sir Charles Gairdner Hospital, Perth, Australia

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Australia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01301625 on ClinicalTrials.gov