Heart Failure Clinical Trial

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

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 HeartWareâ„¢ Ventricular Assist Device (HVADâ„¢) for destination therapy.

The Apogee study is conducted within Medtronic's Product Surveillance Platform.

View Full Description

Full 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.

View Eligibility Criteria

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.

Study is for people with:

Heart Failure

Estimated Enrollment:

124

Study ID:

NCT03697980

Recruitment Status:

Completed

Sponsor:

Medtronic Cardiac Rhythm and Heart Failure

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There are 31 Locations for this study

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Saint Vincent Heart Clinic Arkansas
Little Rock Arkansas, 72205, United States
University of California San Diego
San Diego California, 92103, United States
University of California San Francisco Medical Center
San Francisco California, 94143, United States
Stanford University Hospital
Stanford California, 94305, United States
University of Colorado
Aurora Colorado, 80045, United States
AdventHealth
Orlando Florida, 32804, United States
Northwestern University
Chicago Illinois, 60611, United States
Cardiac Surgery Clinical Research Center
Oak Lawn Illinois, 60453, United States
The University of Kansas Medical Center
Kansas City Kansas, 66160, United States
University of Louisville
Louisville Kentucky, 40202, United States
University of Maryland Medical Center
Baltimore Maryland, 21201, United States
The Johns Hopkins Hospital
Baltimore Maryland, 21287, United States
Tufts Medical Center
Boston Massachusetts, 02111, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
Mayo Clinic Rochester
Rochester Minnesota, 55905, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
NYU Langone Medical Center
New York New York, 10016, United States
Columbia University
New York New York, 10032, United States
The Lindner Christ Hospital
Cincinnati Ohio, 45219, United States
The Ohio State University Wexner Medical Center
Columbus Ohio, 43210, United States
Oklahoma Heart Institute
Tulsa Oklahoma, 74104, United States
Providence St. Vincent Medical Center
Portland Oregon, 97225, United States
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh Pennsylvania, 15213, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
Baylor College of Medicine
Houston Texas, 77030, United States
Houston Methodist Hospital
Houston Texas, 77030, United States
University of Texas Health Sciences Center
Houston Texas, 77030, United States
University of Utah
Salt Lake City Utah, 84132, United States
Sentara Norfolk General Hospital
Norfolk Virginia, 23507, United States
Virginia Commonwalth University Health System
Richmond Virginia, 23298, United States
University of Washington Medical Center
Seattle Washington, 98195, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

124

Study ID:

NCT03697980

Recruitment Status:

Completed

Sponsor:


Medtronic Cardiac Rhythm and Heart Failure

How clear is this clinincal trial information?

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