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| ID | Type | Description | Link |
|---|---|---|---|
| CTRI/2008/091/000203 | Registry Identifier | Clinical Trials Registry - India |
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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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The purpose of this study is to (a) characterize the current management of patients with systolic heart failure (HF) in South Asia following an educational intervention of current guidelines and delivery of disease management tools and (b) to characterize the effect of current therapy on clinical outcomes in patients managed by tertiary care centers across South Asia. Current therapy includes characterization of the post market performance of any market released Medtronic cardiac resynchronization therapy (CRT) or cardiac resynchronization therapy plus implantable cardiac defibrillator (CRT-D) system for cardiac resynchronization therapy (CRT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No-CRT | Experimental | Patients who meet CRT device implantation guidelines (i.e., meet CRT indication and on optimal medical therapy) but who do not get a CRT-P or CRT-D device implanted |
|
| CRT | Experimental | Patients who meet CRT device implantation guidelines (i.e., meet CRT indication and on optimal medical therapy) and receive CRT-P or CRT-D device |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT | Device | Patients who meet CRT device implantation guidelines (i.e., meet CRT indication and on optimal medical therapy) and receive CRT-P or CRT-D device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Composite score | 1. To characterize the long term outcomes (clinical composite score as improved, unchanged or worsened) of patients who meet CRT implant guidelines and (a) receive CRT implant or (b) do not receive the CRT implant. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Demographics | To determine the demographics of HF patients in the registry including LVEF and NYHA Classification. | 2 years FU |
| Profile of patients with positive response to CRT | To characterize the profile of patients with a positive response to CRT. e.g Baseline LVEF |
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Inclusion Criteria:
Exclusion Criteria:
Patient has life expectancy of less than 12 months due to medical conditions other than HF.
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| Name | Affiliation | Role |
|---|---|---|
| C Narasimhan | Care Hospital, Hyderabd-India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Care Hospital | Hyderabad | Andhra Pradesh | 500 034 | India |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| No-CRT | Other | Patients who meet CRT device implantation guidelines (i.e., meet CRT indication and on optimal medical therapy) but who do not get a CRT-P or CRT-D device implanted |
|
| 2 years |