Apogee International

Terminated

• Conditions: Chronic Heart Failure

• Registration Number: NCT04065997
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2019-08-21
• Study First Submitted QC: 2019-08-21
• Study First Posted: 2019-08-22
• Study Start: 2019-09-06
• Status Verified: 2021-07
• Primary Completion: 2021-07-26
• Study Completion: 2021-07-26
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse events	Implant to 12 months	Major adverse events are defined to be occurrence of major infection, major bleeding, device malfunction, stroke or death.

Trial Locations

Locations (31)

St. Vincents Hospital; 🇦🇺 Sydney, Australia

Medical University of Vienna; 🇦🇹 Vienna, Austria

UZ Leuven - Campus Gasthuisberg; 🇧🇪 Leuven, Belgium

Aarhus Universitetshospital; 🇩🇰 Aarhus, Denmark

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum; 🇩🇪 Bad Oeynhausen, Germany

Schuechtermann Klinik; 🇩🇪 Bad Rothenfelde, Germany

Deutsches Herzzentrum Berlin; 🇩🇪 Berlin, Germany

Universitätsklinikum Düsseldorf; 🇩🇪 Duesseldorf, Germany

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

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