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A study to compare safety and efficacy of FOI based vs Nominal mode of CRT implantation

Effect of electrical based optimization on improving electrical and mechanical performance after CRT implantation - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084621
Enrollment
50
Registered
2025-04-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: I509- Heart failure, unspecified Health Condition 2: I501- Left ventricular failure, unspecified

Interventions

Intervention1: Cardiac resynchronization therapy using using fusion-optimized interval (FOI) programming: Followed up for 6 months after CRT implantation Control Intervention1: Cardiac resynchronizati

Sponsors

Dr Bhargav Somaiya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with standard indication of cardiac resynchronization 1.Ejection fraction less than or equal to 35% 2.QRS duration greater than or equal to 130ms 3.Left bundle branch morphology 4.New York Heart Association Functional Class II, III and ambulatory class IV 5.Optimal medical treatment 6.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 greater than 250 ms 7.Right bundle branch block 8.Other diseases with less than 1 year life expectancy

Design outcomes

Primary

MeasureTime frame
To assess the change in electrocardiographic dys-synchrony with LV function changes in the form of QRS narrowing and fragmentation on ECG & Echocardiographic response of more than 15% decrease in LV-ESV (Left Ventricular-End Systolic Volume) and more than 5% increase in LV ejection fraction (LV-EF).Timepoint: At baseline and 6 months

Secondary

MeasureTime frame
Changes in 6 minute walk testTimepoint: 6 months;Changes in NYHA classTimepoint: 6 months;Changes in BNP/NT-proBNP levelsTimepoint: 6 months

Countries

India

Contacts

Public ContactProf Nitish Naik

All India Institute of Medical Sciences, New Delhi

nitishnaik@yahoo.co.in9810416170

Outcome results

None listed

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