Medtronic South Asian Systolic Heart Failure Registry

Phase 4

Completed

• Conditions: Heart Failure
• Interventions: Device: CRT; Other: No-CRT

• Registration Number: NCT01434615
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2011-09-13
• Study First Submitted QC: 2011-09-14
• Study First Posted: 2011-09-15
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-05
• Last Update Posted: 2017-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 502

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CRT	CRT	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
No-CRT	No-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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Care Hospital; 🇮🇳 Hyderabad, Andhra Pradesh, India