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HeartMate 3™ CE Mark Clinical Investigation Plan

NCT02170363 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-06-27

Study results available
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Summary

The purpose of this clinical investigation is to evaluate the performance and safety of the HeartMate 3 Left Ventricular Assist System (HM3 LVAS) To support obtaining CE Mark for the HM3 LVAS in Europe, a multi-center clinical study will be conducted in multiple countries. The clinical study will be conducted in compliance with the Declaration of Helsinki, ICH/GCP and EN ISO 14155:2011 Requirements for Clinical Investigations and in accordance with country-specific requirements, under one clinical study protocol.

This study will evaluate the performance of the HM3 LVAS, side effects and undesirable conditions within acceptable risks and weigh them against the intended performance of HM3 LVAS in accordance with Essential Requirements 2, 5 and 16 of the Active Implantable Medical Device Directive 90/385/EEC (AIMDD).

Conditions

  • Advanced Refractory Left Ventricular Heart Failure

Interventions

DEVICE

Left Ventricular Assist System (LVAS)

Implantation of left ventricular assist device for hemodynamic support

Sponsors & Collaborators

  • Center for Life Sciences

    collaborator UNKNOWN

  • Emergo

    collaborator UNKNOWN

  • KCRI

    collaborator OTHER

  • Thoratec Corporation

    collaborator INDUSTRY

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Carlo Gazzola, B. Sc. · Abbott

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-05-31
Completion
2020-03-09

Countries

  • Australia
  • Austria
  • Canada
  • Czechia
  • Germany
  • Kazakhstan

Study Locations

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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 NCT02170363 on ClinicalTrials.gov