Health Condition 1: I498- Other specified cardiac arrhythmias
Conditions
Interventions
Intervention1: Fusion-optimised interval (FOI): Fusion-optimised interval (FOI) method of AV and VV delay optimization with Intrinsic electrogram based automated algorithms - two most simple and promi
Sponsors
ICMR NEW DELHI
Eligibility
Inclusion criteria
Inclusion criteria: i. Age more than 18 years ii. Patient with HF iii. In sinus rhythm iv. With New York Heart Association (NYHA) functional class II to ambulatory IV despite optimal guideline directed medical treatment. For NYHA I left ventricular EF must be less than or equal to 30% v. LV ejection fraction (LVEF) less than or equal to 35% (for NYHA class II to ambulatory IV) vi. QRS width more than or equal to120 ms with left bundle branch block (LBBB) vii. Successful CRT implantation viii. Post implant RV-LV duration more than or equal to 70 milliseconds ix. Patient is giving consent.
Exclusion criteria
Exclusion criteria: i. Patient with treatable cardiomyopathy ii. Subjects with documented permanent complete AV block or significant AV block (AV interval more than or equal to 250 milliseconds) iii. Patient with atrial fibrillation iv. Life expectancy shorter than 12 months due to any medical condition v. Patient having RBBB or nonspecific IVCD. vi. Subject is awaiting cardiac transplantation or is to receive a VAD. vii. Patient on hemodialysis i. Patient with treatable cardiomyopathy ii. Subjects with documented permanent complete AV block or significant AV block (AV interval more than or equal to 250 milliseconds) iii. Patient with atrial fibrillation iv. Life expectancy shorter than 12 months due to any medical condition v. Patient having RBBB or nonspecific IVCD. vi. Subject is awaiting cardiac transplantation or is to receive a VAD. vii. Patient on hemodialysis viii. Woman of childbearing potential who is planning to be pregnant during the course of the trial. ix. Not wiling to give written consent. x. Not capable of complying with follow up visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We expect the fusion optimized intervals (FOI) strategy to cause Clinical and Anatomical Improvement i.e., composite of LV reverse remodeling and or improvement of 6MWTD at 12 months follow-up. Timepoint: 12 months follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| We expect the fusion optimized intervals (FOI) strategy to cause Clinical and Anatomical Improvement i.e., improvement of 6MWTD at 12 months follow-up.Timepoint: 12 months follow-up. | — |
Countries
India
Contacts
Public ContactDr Nitish Naik
AIIMS NEW DELHI
Outcome results
None listed