Apogee, A HeartWare HVAD Destination Product Surveillance Registry (PSR) Platform
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Heart Failure
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Enrollment
- 136
- Locations
- 33
- Primary Endpoint
- Rate of Major Adverse Events
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed Description
The Apogee study is a prospective, observational, post-market, on-label, multi-site study in Destination Therapy patients. Patients participating in the Medtronic Destination Therapy (DT) Post Approval Study (PAS) (NCT03681210) are eligible for participation in Apogee. Patients enrolled in Apogee will be followed under the Apogee study for one-year post-implant. After participation in Apogee ends, patients will remain enrolled in DT PAS and will continue to be followed as outlined in the DT PAS protocol. The total estimated study duration is 33 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects consented to participate in DT PAS are eligible for participation in Apogee.
Exclusion Criteria
- •There are no exclusion criteria unique to Apogee.
Outcomes
Primary Outcomes
Rate of Major Adverse Events
Time Frame: Implant to 12 months
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, bleeding, device malfunction and CT confirmed stroke were categorized via Intermacs Version 5.0. Events occurring during the implant procedure were excluded.