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Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical SWIFT HM3 PMS

NCT04548128 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 102

Last updated 2023-02-01

No results posted yet for this study

Summary

This is a prospective, post-market, multi-center, non-blinded, single arm study of the HeartMate 3 Left Ventricular Assist System (LVAS). The objective of this study is to evaluate the implantation of the HM3 utilizing techniques other than full median sternotomy (e.g. thoracotomy) and impact on post-implant length of stay.

Conditions

  • Advanced Refractory Left Ventricular Heart Failure

Interventions

DEVICE

HeartMate 3 Left Ventricular Assist System (HM3 LVAS)

This clinical trial investigates implant of the HM3 LVAS by techniques other than full median sternotomy.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Sami Somo, PhD · Abbott

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-17
Primary Completion
2022-07-19
Completion
2022-12-20

Countries

  • United States
  • Canada

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 NCT04548128 on ClinicalTrials.gov