Medtronic South Asian Systolic Heart Failure Registry
This trial is active, not recruiting.
|Sponsor||Medtronic Cardiac Rhythm Disease Management|
|Start date||October 2008|
|End date||December 2013|
|Trial size||502 participants|
|Trial identifier||NCT01434615, CTRI/2008/091/000203, SASHFR|
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).
|Intervention model||parallel assignment|
|Primary purpose||health services research|
Clinical Composite score
time frame: 2 years
time frame: 2 years FU
Profile of patients with positive response to CRT
time frame: 2 years
Male or female participants of any age.
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.
|Official title||SASHFR (South Asian Systolic Heart Failure Registry) : A Multi-center, Nonrandomized, Prospective Study to Collect Data Pertaining to the Demographic and Cardiovascular Profiles, Management Strategies and Clinical Outcomes of HF Patients.|
|Principal investigator||C Narasimhan|
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