Magnetic Resonance Imaging Based Risk Stratification for Defibrillator Implantation in Heart Failure Patients Requiring Cardiac Resynchronisation Therapy
Velammal Medical College Hospital and Research Institute
Phase
Not applicable
Started
2026-08-01
Last updated
2026-08-27
Condition(s) studied
Non Ischemic Cardiomyopathy
Investigational drug(s) / intervention(s)
left bundle branch pacingBiventricular pacing with defibrillator
left bundle branch pacing: Capture of left bundle branch fibers by positioning the lead deep inside the proximal inter ventricular septum. Atrial lead will positioned in the right atrium
Biventricular pacing with defibrillator: Biventricular pacing with right ventricular ICD lead and coronary sinus lead. Atrial lead will be positioned in the right atrium
Study summary
This randomized study aimed to compare the efficacy of LBBP without defibrillator vs biventricular pacing with defibrillator (BiV-ICD/CRT-D) in patients with LB-NICM and left ventricular ejection fraction (LVEF) ≤35% risk categorized by CMR imaging.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Patients with age ≥18 years
2. Typical left bundle branch block as defined by Strauss criteria with LVEF ≤35%
3. Heart failure symptoms despite guideline directed medical therapy (GDMT)
Exclusion Criteria:
1. Patients with angiographic evidence of significant coronary artery disease requiring revascularisation. In patients with significant CAD, LVEF will be re-assessed 3 months after revascularisation to decide about CRT
2. Patients with associated uncorrected congenital or valvular heart disease
3. Expected life-expectance of \<12 months due to associated comorbidities
4. Patients with contrast allergy
5. Baseline non-LBBB morphology
6. Renal dysfunction which limits the acquisition of CMR with contrast
7. Pregnant or lactating women
8. Patients who are unable to comply with study protocol
Primary outcome measure(s)
Number of participants with the following treatment related events in each arm — 12 months 1. Composite of occurrence
1. death,
2. HFH, or
3. sustained VT at 12 months
2. Echocardiographic response (ER) defined as absolute increase in LVEF by \>15% at 12 months
Trial sites (1)
Facility
City
Region
Status
Velammal Medical College Hospital and Research Institute
Madurai
Tamil Nadu
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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