Personalized Therapy Study - HFRS (TriageHF) Post Approval Study
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|ClinicalTrials.gov Identifier: NCT04489225|
Recruitment Status : Recruiting
First Posted : July 28, 2020
Last Update Posted : May 12, 2021
|Condition or disease||Intervention/treatment|
|Heart Failure||Other: Observational|
|Study Type :||Observational|
|Estimated Enrollment :||2200 participants|
|Official Title:||Personalized Therapy Study - Heart Failure Risk Status (TriageHF) Post Approval Study|
|Actual Study Start Date :||August 1, 2020|
|Estimated Primary Completion Date :||January 31, 2025|
|Estimated Study Completion Date :||January 31, 2027|
This single arm observational study includes all patients implanted with a Medtronic Cobalt™ XT ICD or CRT-D MRI SureScan™ (with Attain StabilityQuad™ MRI SureScan™ Model 4798 Lead (ASQ)), who are enrolled in the Medtronic CareLink (CL) Network and Product Surveillance Registry (PSR). Patients will be followed per the standard of care practices of their care provider. All patients must provide a signed informed consent.
Observational only without any intervention
- positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure [ Time Frame: Up to 5 years ]To estimate the positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure
- Number of HF hospitalization or HF related deaths [ Time Frame: Up to 5 years ]Summarize the number of HF hospitalization or HF related deaths that were not preceded by a High-Risk Status.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04489225
|Contact: PSR Study Teamemail@example.com|