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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 function

Impact of fusion-optimized intervals(FOI) in cardiac resynchronization therapy(CRT) implanted patients on ECG-dyssynchrony,LV reverse remodelling,clinical and biochemical parameters

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/044886
Enrollment
50
Registered
2022-08-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I501- Left ventricular failure, unspecified

Interventions

Intervention1: FOI(fusion-optimized intervals) algorithm method of CRT optimization: In CRT-implanted subjects to be included in trail,half of the patients will undergo CRT optimization by method ca

Sponsors

CHANDAN SHARMA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with standard indication of cardiac resynchronization therapy 2.Ejection fraction 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

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

Design outcomes

Primary

MeasureTime frame
1.QRS narrowing on ECG 2.LV reverse remodelling(LV end-systolic volume LVESV,LV end-diastolic volume LVEDV,Ejection fraction EF) Timepoint: 1.QRS narrowing on ECG,Time point-day 1 post CRT implan tation and at 6months 2.LV reverse remodelling(LV end-systolic volume LVESV,LV end-diastolic volume LVEDV,Ejection fraction EF) Time point: at 6 months—

Secondary

MeasureTime frame
1. Clinical response [ Time Frame: 6months ]: 10% increased distance in the 6-minute walk test(6MWT). 2. Change in NYHA class. 3. Change in NT-pro BNP levels. Timepoint: 6 months—

Countries

India

Contacts

Public ContactCHANDAN SHARMA

AIIMS,New Delhi

nitishnaik@yahoo.co.in9810416170

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026