HVP Apogee addendum in Destination Therapy (DT) Post Approval Study (PAS) patients.
Patients must be enrolled in DT PAS first: The purpose of the Apogee study is to further enhance scientific understanding of the implant procedure, optimized blood pressure management, and anticoagulation / antiplatelet therapies. The goals of Apogee are:
• To evaluate collective impact of Apogee standardized guidelines and characterize impact on 12-month aggregate adverse event rate
• To better understand the effects of implant technique and patient management on clinical outcomes
Key Inclusion Criteria:
1. Subjects consented to participate in DT PAS are eligible for participation in Apogee.
There are no exclusion criteria unique to Apogee.
**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
Heart and Vascular
Jacob Abraham MD
- Providence St. Vincent Medical Center