Heart Failure
Conditions
Keywords
Cardiac Resynchronization Therapy, Moderate to advanced, patients, current consensus guidelines
Brief summary
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).
Interventions
DEVICECRT
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
OTHERNo-CRT
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
Sponsors
Medtronic
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient has signed and dated study informed consent. Patients having moderate to severe heart failure (NYHA Class III or IV) EF \< 35% as measured by echo, MUGA, contrast ventriculogram or MRI. QRS duration \> 120 ms.
Exclusion criteria
Patient has life expectancy of less than 12 months due to medical conditions other than HF. * Patient has experienced unstable angina, acute myocardial infarction (MI), coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past 3 months. * Patient is known to have chronic permanent atrial arrhythmias (i.e., cases of long-standing atrial fibrillation of greater than 1 year, including those in which cardioversion has not been indicated or attempted). * Patient is enrolled in any concurrent study that would confound the results of this study. * Patient is pregnant or breastfeeding. * Patient has a CRT device implanted previously. * Patient has had a heart transplant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Composite score | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Demographics | 2 years FU | To determine the demographics of HF patients in the registry including LVEF and NYHA Classification. |
| Profile of patients with positive response to CRT | 2 years | To characterize the profile of patients with a positive response to CRT. e.g Baseline LVEF |
Countries
India
Outcome results
None listed