Apogee International

  • STATUS
    Recruiting
  • End date
    Aug 29, 2024
  • participants needed
    500
  • sponsor
    Medtronic Cardiac Rhythm and Heart Failure
Updated on 29 October 2020
Investigator
Tessa Geelen, PhD
Primary Contact
St. Vincents Hospital (7.3 mi away) Contact
+56 other location

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.

Description

Apogee International is a prospective, non-interventional, post-market, multi-site registry, conducted within Medtronic's Product Surveillance Registry (PSR) Platform. Enrollment into Apogee International will be comprised of newly implanted, commercial use patients with the HeartWare Ventricular Assist Device System (HVAD System).

Sites selected to participate are expected to collect data in at least one of these five

modules
  1. Logfile Download;
  2. Anti-coagulation / Anti-platelet Management;
  3. Blood Pressure (BP) Management;
  4. Acoustic Spectrum Analysis;
  5. Infection Control

Details
Treatment HeartWare Ventricular Assist Device
Clinical Study IdentifierNCT04065997
SponsorMedtronic Cardiac Rhythm and Heart Failure
Last Modified on29 October 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Chronic Heart Failure?
Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
Enrollment into Apogee International will be comprised of newly enrolled, commercial use patients with the HeartWare HVAD System
Patient is consented prior to the HVAD implant procedure

Exclusion Criteria

Patient who is, or is expected to be inaccessible for follow-up
Participation is excluded by local law
Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound the PSR results
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Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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