Status:
COMPLETED
Medtronic South Asian Systolic Heart Failure Registry
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Collaborating Sponsors:
Medtronic
Conditions:
Heart Failure
Eligibility:
All Genders
Phase:
PHASE4
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 deliv...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
502 Patients enrolled
Trial Details
Trial ID
NCT01434615
Start Date
October 1 2008
End Date
December 1 2015
Last Update
December 7 2017
Active Locations (1)
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1
Care Hospital
Hyderabad, Andhra Pradesh, India, 500 034