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MOMENTUM 3 IDE Clinical Study Protocol

NCT02224755 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1028

Last updated 2022-06-27

Study results available
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Summary

The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.

Conditions

  • Advanced Refractory Left Ventricular Heart Failure

Interventions

DEVICE

HeartMate 3 LVAS

Implantation of HeartMate 3 LVAD to evaluate the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure

DEVICE

HeartMate II LVAS

Implantation of the commercially approved HeartMate II LVAD which is the standard treatment for advanced heart failure

Sponsors & Collaborators

  • Thoratec Corporation

    collaborator INDUSTRY

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Daniel Crandall, PhD · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-02
Primary Completion
2018-09-28
Completion
2019-03-26

Countries

  • United States

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 NCT02224755 on ClinicalTrials.gov