Medtronic South Asian Systolic Heart Failure Registry

Medtronic Cardiac Rhythm and Heart Failure502 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

502

Conditions

Heart Failure

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

Demographics

To determine the demographics of HF patients in the registry including LVEF and NYHA Classification.

Time frame: 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