MedTrace Logo

Hong Kong and Taiwan HM3 PMS

NCT04703855 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-07-01

Study results available
· View outcomes & findings →

Summary

Hong Kong and Taiwan HM3 PMS is a prospective, single arm, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure. The PMS will enroll approximately 30 patients, that meet the HM3 commercially approved labelling indications, from approximately 4 sites in Hong Kong and Taiwan. PMS participants will be followed until the 24 months follow-up visit or until they experience an outcome, whichever comes first.

Conditions

  • Advanced Heart Failure

Interventions

DEVICE

HeartMate 3™ left ventricular assist system (HM3 LVAS)

Advanced heart failure patients will be implanted with the HM3 LVAS

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Carlo Gazzola, B. Sc. · Abbott Medical Devices

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-14
Primary Completion
2022-03-31
Completion
2022-06-30
FDA Device
Yes

Countries

  • Hong Kong
  • Taiwan

Study Locations

More Related Trials

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 NCT04703855 on ClinicalTrials.gov