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

Chronic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03697980
• Other study ID #: Apogee
• Status: Completed
• Start date: January 17, 2019
• Est. completion date: February 10, 2022

Study information

• Verified date: November 2023
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: February 10, 2022
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Device:
• HeartWare Ventricular Assist Device
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).

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	The Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	The Lindner Christ Hospital	Cincinnati	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	Baylor College of Medicine	Houston	Texas
United States	Houston Methodist Hospital	Houston	Texas
United States	University of Texas Health Sciences Center	Houston	Texas
United States	The University of Kansas Medical Center	Kansas City	Kansas
United States	Saint Vincent Heart Clinic Arkansas	Little Rock	Arkansas
United States	University of Louisville	Louisville	Kentucky
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Columbia University	New York	New York
United States	NYU Langone Medical Center	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Cardiac Surgery Clinical Research Center	Oak Lawn	Illinois
United States	AdventHealth	Orlando	Florida
United States	University of Pittsburgh Medical Center UPMC Presbyterian	Pittsburgh	Pennsylvania
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Virginia Commonwalth University Health System	Richmond	Virginia
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah
United States	University of California San Diego	San Diego	California
United States	University of California San Francisco Medical Center	San Francisco	California
United States	University of Washington Medical Center	Seattle	Washington
United States	Stanford University Hospital	Stanford	California
United States	Oklahoma Heart Institute	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Major Adverse Events	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.	Implant to 12 months