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DOT HeartMate 3 Study

NCT04974684 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-08-20

Study results available
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Summary

A prospective, single-center, randomized controlled trial of the feasibility and safety of apixaban in HeartMate 3 patients.

Conditions

  • LVAD (Left Ventricular Assist Device) Thrombosis

Interventions

DEVICE

HeartMate 3

Patients implanted with HeartMate 3 will be randomized in 2:1 ratio in interventional and control group. Patients in interventional group will be switched to therapy with apixaban instead of warfarin.

DRUG

Apixaban

Patients implanted with HeartMate 3 will be randomized in 2:1 ratio in interventional and control group. Patients in interventional group will be switched to therapy with apixaban instead of warfarin.

Sponsors & Collaborators

  • Institute for Clinical and Experimental Medicine

    lead OTHER_GOV

Principal Investigators

  • Ivan Netuka, MD, PhD · Institute for Clinical and Experimental Medicine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2024-03-01
Completion
2024-03-01
FDA Device
Yes

Countries

  • Czechia

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 NCT04974684 on ClinicalTrials.gov