Apogee, A HeartWare HVAD Destination Product Surveillance Registry (PSR) Platform

Completed

• Conditions: Chronic Heart Failure

• Registration Number: NCT03697980
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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.

Study Timeline

• Study First Submitted: 2018-10-04
• Study First Submitted QC: 2018-10-04
• Study First Posted: 2018-10-05
• Study Start: 2019-01-17
• Primary Completion: 2022-02-10
• Study Completion: 2022-02-10
• Results First Submitted: 2023-02-06
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-30
• Last Update Submitted: 2023-11-30
• Results First Posted: 2023-12-04
• Last Update Posted: 2023-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Major Adverse Events	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.

Trial Locations

Locations (33)

Saint Vincent Heart Clinic Arkansas; 🇺🇸 Little Rock, Arkansas, United States

University of California San Diego; 🇺🇸 San Diego, California, United States

University of California San Francisco Medical Center; 🇺🇸 San Francisco, California, United States

Stanford University Hospital; 🇺🇸 Stanford, California, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

AdventHealth; 🇺🇸 Orlando, Florida, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Cardiac Surgery Clinical Research Center; 🇺🇸 Oak Lawn, Illinois, United States

The University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

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