A clinical trial to study effect of new method of CRT-optimization (FOI fusion-optimized intervals method) in cardiac resynchronization therapy(CRT) implanted patients on cardiac functio
Not Applicable
- Conditions
- Health Condition 1: I501- Left ventricular failure, unspecified
- Registration Number
- CTRI/2022/08/044886
- Lead Sponsor
- CHANDAN SHARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Patients with standard indication of cardiac resynchronization therapy
2.Ejection fraction �35%.
3.QRS duration �130ms.
4.Left bundle branch morphology.
5.New York Heart Association Functional Class II,III and ambulatory class IV.
6.On optimal medical treatment.
7.With preserved intrinsic AV conduction.
Exclusion Criteria
1.Patient refusal.
2.Cardiomyopathy with a reversible cause.
3.Patients planned for heart transplantation.
4.Atrial fibrillation.
5.Complete AV block.
6.AV delay >250 ms.
7.Right bundle branch block.
8.Other diseases with < 1 year life expectancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.QRS narrowing on ECG <br/ ><br>2.LV reverse remodelling(LV end-systolic volume LVESV,LV end-diastolic volume LVEDV,Ejection fraction EF) <br/ ><br> <br/ ><br>Timepoint: 1.QRS narrowing on ECG,Time point-day 1 post CRT implan tation and at 6months <br/ ><br>2.LV reverse remodelling(LV end-systolic volume LVESV,LV end-diastolic volume LVEDV,Ejection fraction EF) <br/ ><br>Time point: at 6 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Clinical response [ Time Frame: 6months ]: 10% increased distance in the 6-minute walk test(6MWT). <br/ ><br>2.Change in NYHA class. <br/ ><br>3.Change in NT-pro BNP levels. <br/ ><br>Timepoint: 6 months