MRI-guided risk-based pacing for heart failure with reduced ejection fraction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, prospective, randomized trial enrolling adults with non-ischemic cardiomyopathy, LVEF ≤35%, and heart failure symptoms despite GDMT. Participants undergo contrast-enhanced CMR to stratify risk by scar burden; low-risk patients (scar absent or <5%) are randomized 1:1 to LBBP without defibrillator or CRT-D with biventricular pacing. The LBBP procedure uses a 3830 lead via a proximal IVS approach, with fallback CS-based BiV pacing if LBBP is unsuccessful; in CRT-D arms, postero-lateral CS lead placement and a defibrillator lead are used. Primary endpoints focus on pacing effectiveness and clinical outcomes, with feasibility of alternative pacing strategies in case of technical failure. Inclusion criteria include adults ≥18 with typical LBBB and LVEF ≤35%, while key exclusions involve significant CAD requiring revascularization, non-LBBB patterns, pregnancy, contrast allergy, and other conditions limiting protocol adherence.

Why it matters

Who can join: the full rules

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

Where it's running

• Velammal Medical College Hospital and Research Institute
  Madurai, Tamil Nadu, India Recruiting

Study contacts

• Study coordinator: Shunmuga Sundaram Ponnusamy, MD, FHRS
• Email: shunmuga.pgi@gmail.com
• Phone: +919444712846

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.