Medtronic South Asian Systolic Heart Failure Registry (SASHFR)

Medtronic

Status and phase: Completed; Phase 4

Conditions: Heart Failure

Treatments: Other: No-CRT; Device: CRT

Study type: Interventional

Funder types: Industry

Identifiers

NCT01434615

CTRI/2008/091/000203 (Registry Identifier)

SASHFR

Details and patient eligibility

About

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).

Enrollment: 502 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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502 participants in 2 patient groups

No-CRT

Experimental group

Description:

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

Treatment:

Other: No-CRT

CRT

Experimental group

Description:

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

Treatment:

Device: CRT