NCT07791407

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
23mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Aug 2026Jul 2028

First Submitted

Initial submission to the registry

July 12, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2028

Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

12 months

First QC Date

July 12, 2026

Last Update Submit

August 25, 2026

Conditions

Non Ischemic Cardiomyopathy

Keywords

Cardiac resynchronisation therapy

Outcome Measures

Primary Outcomes (1)

  • Number of participants with the following treatment related events in each arm

    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

    12 months

Secondary Outcomes (1)

  • Number of participants with the following treatment related events in each arm

    6 and 12 months

Study Arms (2)

LBBP without defibrillator:

EXPERIMENTAL

Left bundle branch pacing along with right atrial pacing

Device: left bundle branch pacing

BiV-ICD

ACTIVE COMPARATOR

Biventricular pacing with defibrillator lead using RV-ICD lead, LV lead and atrial lead

Device: Biventricular pacing with defibrillator

Interventions

left bundle branch pacingDEVICE

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

LBBP without defibrillator:
Biventricular pacing with defibrillatorDEVICE

Biventricular pacing with right ventricular ICD lead and coronary sinus lead. Atrial lead will be positioned in the right atrium

BiV-ICD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with age ≥18 years
  • Typical left bundle branch block as defined by Strauss criteria with LVEF ≤35%
  • Heart failure symptoms despite guideline directed medical therapy (GDMT)

You may not qualify if:

  • 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
  • Patients with associated uncorrected congenital or valvular heart disease
  • Expected life-expectance of \<12 months due to associated comorbidities
  • Patients with contrast allergy
  • Baseline non-LBBB morphology
  • Renal dysfunction which limits the acquisition of CMR with contrast
  • Pregnant or lactating women
  • Patients who are unable to comply with study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Velammal Medical College Hospital and Research Institute

Madurai, Tamil Nadu, 625009, India

RECRUITING

Related Publications (1)

  • Ponnusamy SS, Ganesan V, Ramalingam V, Syed T, Mariappan S, Murugan S, Kumar M, Anand V, Murugan M, Vijayaraman P. MAgnetic resonance imaging based DUal lead cardiac Resynchronization therapy: A prospectIve Left Bundle Branch Pacing study (MADURAI LBBP study). Heart Rhythm. 2023 Aug;20(8):1119-1127. doi: 10.1016/j.hrthm.2023.05.019. Epub 2023 May 20.

    PMID: 37217065BACKGROUND

MeSH Terms

Interventions

Cardiac Resynchronization TherapyDefibrillators

Intervention Hierarchy (Ancestors)

Cardiac Pacing, ArtificialElectric Stimulation TherapyTherapeuticsElectrodesElectrical Equipment and SuppliesEquipment and Supplies

Central Study Contacts

Shunmuga Sundaram Ponnusamy, MD, FHRS

CONTACT

+919444712846shunmuga.pgi@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 12, 2026

First Posted

August 27, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

July 15, 2027

Study Completion (Estimated)

July 15, 2028

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)