Non Ischemic CardiomyopathyMADURAI CRTNCT07791407
Magnetic Resonance Imaging Based Risk Stratification for Defibrillator Implantation in Heart Failure Patients Requiring Cardiac Resynchronisation Therapy
A study testing left bundle branch pacing and Biventricular pacing with defibrillator in people with Non Ischemic Cardiomyopathy, run by Velammal Medical College Hospital and Research Institute at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Ischemic Cardiomyopathy
- What is being tested?
- left bundle branch pacing and Biventricular pacing with defibrillator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2026to 15 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Velammal Medical College Hospital and Research Institute
Madurai, Tamil Nadu, 625009
Shunmuga Sundaram Ponnusamy, MD,, FHRS, +919444712846, shunmuga.pgi@gmail.com
About this study
Official title: Magnetic Resonance Imaging Based Risk Stratification for Defibrillator Implantation in Heart Failure Patients Requiring Cardiac Resynchronization Therapy (MADURAI CRT)
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.
Read the detailed description
This is a single centre, prospective, randomized study in which patients with LB-NICM, LVEF ≤35% and heart failure despite guideline directed medical therapy (GDMT) will be included. CMR with gadolinium contrast will be performed to risk categorize the patient into low-risk or high risk based on presence of scar. Low risk patients (without scar ?<5%) will be randomized in 1:1 fashion to receive either LBBP without defibrillator or traditional CRT-D with biventricular pacing. LBBP will be performed by premature ventricular complex guided approach with 3830 selectsecure lead and C315His sheath in the proximal interventricular septum 1.5-2 cm distal to His bundle. LBB capture will be confirmed as per standard criteria. If LBBP lead implantation is unsuccessful, a coronary sinus lead will be placed to achieve biventricular pacing. In patients randomized to BiV-ICD, left ventricular lead will be placed in the postero-lateral branch of the coronary sinus with Q-LV duration of >90ms. If coronary sinus lead placement is unsuccessful, a LBBP lead will be implanted. The defibrillator lead will deployed in the right ventricular apical septum.
- Conditions
- Non Ischemic Cardiomyopathy
- Being tested
- left bundle branch pacing, Biventricular pacing with defibrillator
- Keywords
- Cardiac resynchronisation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Biventricular pacing with defibrillatorDevice
Biventricular pacing with right ventricular ICD lead and coronary sinus lead. Atrial lead will be positioned in the right atrium
| Study group | Role | What they receive |
|---|---|---|
| LBBP without defibrillator: | Experimental | Left bundle branch pacing along with right atrial pacing Receives: Device: left bundle branch pacing |
| BiV-ICD | Active comparator | Biventricular pacing with defibrillator lead using RV-ICD lead, LV lead and atrial lead Receives: Device: Biventricular pacing with defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with the following treatment related events in each arm
- Composite of occurrence
- death,
- HFH, or
- sustained VT at 12 months
- Echocardiographic response (ER) defined as absolute increase in LVEF by >15% at 12 months
Measured: 12 months
Secondary outcomes (1)
Number of participants with the following treatment related events in each arm
- Echocardiographic hyper-response (EHR) defined as normalisation of LVEF (≥50%) at 6 and 12 months
- Need for ICD upgrade (persistent LVEF <35% or sustained VT/VF) at 12 months
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Ischemic CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Velammal Medical College Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shunmuga Sundaram Ponnusamy MD, Velammal Medical College Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791407
- Sponsor's protocol ID
- MADURAI CRT
- Acronym
- MADURAI CRT
- Status last verified
- Aug 2026
- First submitted
- 12 Jul 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37217065
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging Based Risk Stratification for Defibrillator Implantation in Heart Failure Patients Requiring Cardiac Resynchronization Therapy (MADURAI CRT)
- ClinicalTrials.gov ID
- NCT07791407
- Acronym / sponsor ID
- MADURAI CRT / MADURAI CRT
- Conditions
- Non Ischemic Cardiomyopathy
- Keywords
- Cardiac resynchronisation therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Velammal Medical College Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Jul 2028 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single centre, prospective, randomized study in which patients with LB-NICM, LVEF ≤35% and heart failure despite guideline directed medical therapy (GDMT) will be included. CMR with gadolinium contrast will be performed to risk categorize the patient into low-risk or high risk based on presence of scar. Low risk patients (without scar ?<5%) will be randomized in 1:1 fashion to receive either LBBP without defibrillator or traditional CRT-D with biventricular pacing. LBBP will be performed by premature ventricular complex guided approach with 3830 selectsecure lead and C315His sheath in the proximal interventricular septum 1.5-2 cm distal to His bundle. LBB capture will be confirmed as per standard criteria. If LBBP lead implantation is unsuccessful, a coronary sinus lead will be placed to achieve biventricular pacing. In patients randomized to BiV-ICD, left ventricular lead will be placed in the postero-lateral branch of the coronary sinus with Q-LV duration of >90ms. If coronary sinus lead placement is unsuccessful, a LBBP lead will be implanted. The defibrillator lead will deployed in the right ventricular apical septum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LBBP without defibrillator: | Experimental | Device: left bundle branch pacingLeft bundle branch pacing along with right atrial pacing |
| BiV-ICD | Active comparator | Device: Biventricular pacing with defibrillatorBiventricular pacing with defibrillator lead using RV-ICD lead, LV lead and atrial lead |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| left bundle branch pacingCapture of left bundle branch fibers by positioning the lead deep inside the proximal inter ventricular septum. Atrial lead will positioned in the right atrium | Device | LBBP without defibrillator: |
| Biventricular pacing with defibrillatorBiventricular pacing with right ventricular ICD lead and coronary sinus lead. Atrial lead will be positioned in the right atrium | Device | BiV-ICD |
Primary outcome
Number of participants with the following treatment related events in each arm
Time frame: 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
1 secondary outcome
Number of participants with the following treatment related events in each arm
Time frame: 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Background: PubMed 37217065Ponnusamy 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.
- Individual participant dataSharing planned: No
Related trials for Non Ischemic Cardiomyopathy
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Not yet recruiting
MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
Ventricular Tachycardia (VT), Ischemic Cardiomyopathy
Not yet recruiting
Pivotal Study to Evaluate Catheter Ablation in Patients With Scar-Related Monomorphic Sustained VT in the Ventricular Ectopy and Reduction in Tachycardia Ablation Studies Program VERITAS SCAR VT
Scar-related Monomorphic Sustained VT
RecruitingObservational study
Non-ischemic Cardiomyopathy Registry, Biobank and Imaging Data Repository
Non-ischemic Cardiomyopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing left bundle branch pacing and Biventricular pacing with defibrillator in people with Non Ischemic Cardiomyopathy, run by Velammal Medical College Hospital and Research Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shunmuga Sundaram Ponnusamy, MD, FHRS (+919444712846, shunmuga.pgi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with the following treatment related events in each arm (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07791407, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.