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MOMENTUM 3 Continued Access Protocol

NCT02892955 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1685

Last updated 2022-06-27

Study results available
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Summary

The objective of the study is to continue to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the the MOMENTUM 3 IDE Study.

Conditions

  • Advanced Refractory Left Ventricular Heart Failure

Interventions

DEVICE

HeartMate 3 LVAS

Implantation of HeartMate 3 LVAD to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the MOMENTUM 3 IDE Study.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Marie-Elena Brett · Abbott Medical Devices

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2020-12-31
Completion
2021-03-31
FDA Device
Yes

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 NCT02892955 on ClinicalTrials.gov