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NCT03697980 · ClinicalTrials.gov registry record
Apogee, A HeartWare HVAD Destination Product Surveillance Registry (PSR) Platform
A clinical trial, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Completed
- Registry status
- 136
- Enrollment target
NCT03697980: Completed study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
NCT03697980 is a clinical trial that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 136 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03697980 has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- COMPLETED
- Registry status
- 136 participants
- Enrollment target
Study Summary
Medtronic is sponsoring the Apogee study to further enhance scientific understanding of the implant procedure, optimized blood pressure management, and anticoagulation/ antiplatelet therapy in patients receiving a Medtronic HeartWare™ Ventricular Assist Device (HVAD™) for destination therapy. The Apogee study is conducted within Medtronic's Product Surveillance Platform.
Primary Outcome
Freedom from event is the probability (expressed as a percent of 100) the participant did not have a major adverse event during 12 months post implant via the Kaplan-Meier method. Participants that did not have a major adverse event were censored at the time of last follow-up in Apogee or their end of study at 12 months post implant, whichever occurred first. Major adverse events are defined to be occurrence of infection, bleeding, device malfunction, CT confirmed stroke, or death. Infection, b
Interventions
- DEVICE HeartWare Ventricular Assist Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2019-01-17 |
| Est. Completion | 2022-02-10 |
What the finished NCT03697980 record still lists
NCT03697980 is an observational study that tracks outcomes without assigning an intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which HeartWare Ventricular Assist Device is the first listed.
NCT03697980 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03697980 about?
NCT03697980 is a clinical study titled "Apogee, A HeartWare HVAD Destination Product Surveillance Registry (PSR) Platform". Medtronic is sponsoring the Apogee study to further enhance scientific understanding of the implant procedure, optimized blood pressure management, and anticoagulation/ antiplatelet therapy in patients receiving a Medtronic HeartWare™ Ventricular Assist Device (HVAD™) for destination therapy. The A...
What is the current status of trial NCT03697980?
This trial is currently completed. The enrollment target is 136 participants. The study started on 2019-01-17. Estimated completion is 2022-02-10.
What interventions are being tested in trial NCT03697980?
The interventions under investigation include: HeartWare Ventricular Assist Device (DEVICE).
Who is sponsoring clinical trial NCT03697980?
This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.
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