Apogee, A HeartWare HVAD Destination Product Surveillance Registry (PSR) Platform
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/5/2019 |
| Start Date: | January 17, 2019 |
| End Date: | October 2020 |
| Contact: | Apogee Manager |
| Email: | samantha.ly@medtronic.com |
| Phone: | 508-532-4722 |
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.
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.
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.
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.
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.
We found this trial at
7
sites
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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505 Parnassus Ave
San Francisco, California 94143
San Francisco, California 94143
(415) 476-1000
University of California, San Francisco Medical Center UCSF Medical Center is recognized throughout the world...
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