MedTrace Logo

Apogee International

NCT04065997 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 147

Last updated 2021-08-03

No results posted yet for this study

Summary

Medtronic is sponsoring the Apogee International registry to further confirm safety and efficacy of the HVAD™ System when used as intended, in "real world" clinical practice and to enhance scientific understanding of the implant procedure, optimized blood pressure management, anticoagulation/ antiplatelet therapies, logfile analysis and acoustic spectrum analysis in patients receiving a Medtronic HeartWare™ HVAD™ for bridge to transplant and destination therapy indications.

Conditions

Interventions

DEVICE

HeartWare Ventricular Assist Device

The HVAD is an implantable centrifugal rotary blood pump that is implanted in the pericardial space and is designed to provide up to 10 L/min of blood flow from the left ventricular to the aorta. The HVAD System is comprised of three major components: the HVAD (pump) with inflow and outflow conduits, a Controller (microprocessor unit that controls the operation of the HVAD), and power sources (AC and DC power adapters that provide power to the Controller and implanted HVAD).

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-06
Primary Completion
2021-07-26
Completion
2021-07-26
FDA Device
Yes

Countries

  • Australia
  • Austria
  • Belgium
  • Denmark
  • Finland
  • Germany
  • Italy
  • Kazakhstan
  • Lebanon
  • Netherlands
  • Norway
  • Poland
  • Serbia
  • Spain
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT04065997 on ClinicalTrials.gov