Physiologic Signals and Signatures With the Accuryn Monitoring System - A Retrospective and Prospective Analysis (The Accuryn Registry)
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
The Accuryn Registry Study is an open-ended, global, multi-center, retrospective and prospective, single-arm data collection study with an FDA cleared device. The target population are cardiovascular surgery patients. Physiologic data measurements will be collected from enrolled subjects using electronic medical records and data streams via the Accuryn Monitoring System.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Signed or Verbal Informed Consent as required by IRB (if applicable).
• Adult (age ≥ 18).
• Monitored on the Accuryn® Monitoring System during their procedure and ICU stay (for retrospective enrollment).
• Patient is undergoing cardiac surgical intervention(s).
Locations
United States
California
Cedars-Sinai Medical Center
ACTIVE_NOT_RECRUITING
Los Angeles
San Francisco VA Medical Center
TERMINATED
San Francisco
Washington, D.c.
George Washington University Hospital
RECRUITING
Washington D.c.
Florida
Cleveland Clinic Florida
RECRUITING
Weston
Kentucky
Jewish Hospital / University of Louisville
RECRUITING
Louisville
North Carolina
Mission Health Hospital
RECRUITING
Asheville
Duke University Hospital
RECRUITING
Durham
Wake Forest Baptist Medical Center
ACTIVE_NOT_RECRUITING
Winston-salem
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Contact Information
Primary
Bev Ann Blackwell
bblackwell@potreromed.com
256-679-5422
Backup
Ariane Marcus
amarcus@potreromed.com
888-635-7280
Time Frame
Start Date: 2020-12-21
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 2500
Treatments
Accuryn Monitoring System
Observational only (no intervention). Patients undergoing cardiovascular surgical intervention(s) monitored with the Accuryn Monitoring System (per standard of care) during their hospital stay
Authors
Related Therapeutic Areas
Sponsors
Leads: Potrero Medical