Apogee, A HeartWare HVAD Destination Product Surveillance Registry (PSR) Platform
- Conditions
- Chronic Heart Failure
- Interventions
- Device: HeartWare Ventricular Assist Device
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 136
- Subjects consented to participate in DT PAS are eligible for participation in Apogee.
- There are no exclusion criteria unique to Apogee.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HVAD Left Ventricular Assist Device HeartWare Ventricular Assist Device Device: HeartWare Ventricular Assist Device Other Names: HVAD The HVAD is an implantable centrifugal rotary blood pump that is implanted in the pericardial space and is designed to provide up to 10 L/min of blood flow from the left ventricular to the aorta. The HVAD System is comprised of three major components: the HVAD (pump) with inflow and outflow conduits, a Controller (microprocessor unit that controls the operation of the HVAD), and power sources (AC and DC power adapters that provide power to the Controller and implanted HVAD).
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (33)
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
The Lindner Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Oklahoma Heart Institute
🇺🇸Tulsa, Oklahoma, United States
University of California San Francisco Medical Center
🇺🇸San Francisco, California, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
University of Texas Health Sciences Center
🇺🇸Houston, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Stanford University Hospital
🇺🇸Stanford, California, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Pittsburgh Medical Center UPMC Presbyterian
🇺🇸Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Cardiac Surgery Clinical Research Center
🇺🇸Oak Lawn, Illinois, United States
The University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
The Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Columbia University
🇺🇸New York, New York, United States
Virginia Commonwalth University Health System
🇺🇸Richmond, Virginia, United States
AdventHealth
🇺🇸Orlando, Florida, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
Saint Vincent Heart Clinic Arkansas
🇺🇸Little Rock, Arkansas, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
University of California San Diego
🇺🇸San Diego, California, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States