Heart Failure
Conditions
Brief summary
The purpose of this study is to evaluate the cardiac resynchronization therapy (CRT) response in a real-world patient population and evaluate options to address non-response and patient management.
Detailed description
The Personalized CRT study is a multi-center, single arm, prospective observational study. The purpose of the study is to better understand and characterize heart failure (HF) patient management by characterizing the use and clinical benefit of Medtronic market-released features/tools within the HF Patient Management portfolio.
Interventions
DEVICECardiac Resynchronization Therapy
Sponsors
Medtronic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Inclusion criteria
* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements * Patient has or is intended to receive or be treated with an eligible CRT device * Patient within 30 days of therapy received at the time of their initial PSR platform enrollment
Exclusion criteria
* Patient who is, or is expected to be inaccessible for follow-up * Patient with
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CRT Response | Every 3-9 months | A Clinical Composite Score (CCS) endpoint will be used to assess a change in CRT response for all patients from baseline to follow-up visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatments for CRT non-response | Every 3-9 months | Summary statistics will be obtained to describe the distribution of different treatments (or no treatment) the patient receives. |
| Treatment effects for different CRT features in the CRT non-responder population | Every 3-9 months | A Clinical Composite Score (CCS) endpoint will be used to assess a change in CRT response. |
| Patient outcome post initial CRT implant | Every 3-9 months | Patient outcome will be measured as the patient first occurrence of HF related hospitalization or death. |
Countries
Belgium, Canada, France, Germany, Italy, Malaysia, Netherlands, Serbia, South Korea, Spain, Sweden, United Kingdom, United States
Outcome results
None listed