Overview

This trial is active, not recruiting.

Condition heart failure
Treatments crt, no-crt
Phase phase 4
Sponsor Medtronic Cardiac Rhythm Disease Management
Collaborator Medtronic
Start date October 2008
End date December 2013
Trial size 502 participants
Trial identifier NCT01434615, CTRI/2008/091/000203, SASHFR

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
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
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
(Experimental)
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
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

Primary Outcomes

Measure
Clinical Composite score
time frame: 2 years

Secondary Outcomes

Measure
Demographics
time frame: 2 years FU
Profile of patients with positive response to CRT
time frame: 2 years

Eligibility Criteria

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by Medtronic Cardiac Rhythm Disease Management.