South Asian Systolic Heart Failure Registry (SASHFR) : Registry to understand benefits of implantable device therapy known as cardiac resynchronization therapy (CRT) on patients with heart failure
- Conditions
- Health Condition 1: null- Moderate to advanced heart failure patients who meet current consensus guidelines for cardiac re-synchronization therapy
- Registration Number
- CTRI/2008/091/000203
- Lead Sponsor
- India Medtronic Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 502
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.
Sinus rhythm
Patient is willing to remain available for follow-up visits.
Patient is willing and able to comply with the protocol.
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
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br/ ><br>2. To characterize health care utilization (based on hospitalization days) of indicated patients receiving CRT and not receiving CRT. <br/ ><br>3. To determine the overall performance and changes in HF performance between baseline, 3, 9, 15, 21 and 24 months in all patients. <br/ ><br>Timepoint: from enrollment to 24 months
- Secondary Outcome Measures
Name Time Method Secondary Objectives: <br>1. To determine the demographics of HF patients in the registry.<br>2. To characterize the profile of patients with a positive response to CRT <br>3. To determine the percentage of HF patients who meet CRT implant guidelines after 3 months of optimal medical therapy post-enrollment within the group of patients who had not been on optimal medical therapy for at least 3 months prior to enrollment<br>4. To determine the overall performance and changes in seven HF performance metrics between baseline, 3, 9, and 24 months in individual practices.<br>5. To characterize the outcomes of patients treated with CRT-P versus CRT-D.<br>6. To characterize the implant procedure and follow-up management of patients treated with CRT in South Asia.<br>Timepoint: from enrollments to 24 months