Medtronic is sponsoring the HFRS PAS to evaluate the HFRS feature (TriageHF) when used in routine clinical practice following commercial release. The HFRS PAS is conducted within Medtronic's Product Surveillance Registry (PSR) platform.
The HFRS PAS is a global, prospective, observational, multi-site study. Patients implanted with a Medtronic Cobalt™ XT CRT (with Attain StabilityQuad™ MRI SureScan™ Model 4798 Lead (ASQ)) or ICD device who are enrolled in the Medtronic CareLink (CL) Network and the PSR will be followed per the standard of care practices of their care provider.
Study Type
OBSERVATIONAL
Enrollment
2,200
Observational only without any intervention
positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure
To estimate the positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure
Time frame: Up to 5 years
Number of HF hospitalization or HF related deaths
Summarize the number of HF hospitalization or HF related deaths that were not preceded by a High-Risk Status.
Time frame: Up to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Southwest EP
Chandler, Arizona, United States
Saint Vincent Heart Clinic Arkansas
Little Rock, Arkansas, United States
Chula Vista Cardiac Center
Chula Vista, California, United States
Cardiovascular Consultants Medical Group
Van Nuys, California, United States
Cardiology Associates Medical Group
Ventura, California, United States
Colorado Springs Cardiology
Colorado Springs, Colorado, United States
Denver Heart
Denver, Colorado, United States
Colorado Heart and Vascular, PC
Lakewood, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale New Haven Hospital
New Have, Connecticut, United States
...and 82 more locations