Health Condition 1: null- Moderate to advanced heart failure patients who meet current consensus guidelines for cardiac re-synchronization therapy
Conditions
Interventions
Intervention1: Not applicable: All patients included in the registry will be indicated for Cardiac Resynchronisation Therapy ( CRT).The patient will chose whether to receive a CRT implant or not. The
Sponsors
India Medtronic Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patient has signed and dated study informed consent. Patients having moderate to severe heart failure (NYHA Class III or IV) EF 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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 2. To characterize health care utilization (based on hospitalization days) of indicated patients receiving CRT and not receiving CRT. 3. To determine the overall performance and changes in HF performance between baseline, 3, 9, 15, 21 and 24 months in all patients. Timepoint: from enrollment to 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives: 1. To determine the demographics of HF patients in the registry. 2. To characterize the profile of patients with a positive response to CRT 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 4. To determine the overall performance and changes in seven HF performance metrics between baseline, 3, 9, and 24 months in individual practices. 5. To characterize the outcomes of patients treated with CRT-P versus CRT-D. 6. To characterize the implant procedure and follow-up management of patients treated with CRT in South Asia. Timepoint: from enrollments to 24 months | — |
Countries
India
Contacts
Public ContactRajesh Radhakrishnan
India Medtronic Pvt ltd
Outcome results
None listed