Alternative pacing methods for heart failure patients with left bundle branch block

Direct HIS/LBB Pacing as an Alternative to Biventricular Pacing in Patients With Symptomatic Heart Failure Despite Optimal Medical Treatment and an ECG With a Typical Left Bundle Branch Block Pattern.

This study is testing new pacing methods for heart failure patients with a specific heart block to see if they work better than the usual treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rigshospitalet, Denmark (Academic / other)
• Locations: 1 site (Copenhagen, Hovedstaden)
• Trial ID: NCT04409119 on ClinicalTrials.gov

What this trial studies

This study investigates the feasibility of using direct HIS pacing or left bundle branch pacing (LBB pacing) as alternatives to traditional biventricular pacing in patients suffering from symptomatic heart failure and exhibiting a typical left bundle branch block pattern on their ECG. The trial will randomize 150 patients across two centers, comparing the effectiveness of conventional cardiac resynchronization therapy (CRT) with the new pacing techniques. The HIS/LBB pacing approach aims to improve left ventricular activation while minimizing complications associated with biventricular pacing. The study will assess the pacing thresholds and overall cardiac function in these patients.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with ischemic or non-ischemic cardiomyopathy, LVEF ≤ 35%, and NYHA class II-IV heart failure symptoms despite optimal medical treatment.

Not a fit: Patients who already have an existing biventricular pacing system or those not meeting the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more effective and less invasive treatment option for heart failure patients with left bundle branch block.

How similar studies have performed: While biventricular pacing has been the standard for over a decade, the HIS and LBB pacing methods are relatively novel and have shown promise in preliminary studies.

Eligibility criteria

Inclusion Criteria:

* Patients over 18 years of age, ischemic or non-ischemic cardiomyopathy with LVEF ≤ 35% assessed by echocardiography, NYHA class II-IV heart failure symptoms despite optimal medical treatment and

  * Either planned new implantation of a biventricular pacing system (CRT-P or CRT-D), where the ECG is with sinus rhythm and a typical left bundle branch block (see definition below)
  * Or planned upgrade of an existing pacemaker or ICD to a biventricular pacing system (CRT-P or CRT-D), where the ECG is with sinus rhythm and a typical left bundle branch block or there has been\> 90% right ventricular pacing from an existing pacemaker for at least 2 months prior to enrollment
* Signed informed consent

Typical left bundle branch block:

QRS width \> 130 msec for women and \> 140 msec for men QS or rS pattern in leads V1 and V2, and mid-QRS plateau phase with or without extras in at least 2 of leads V1, V2, V5, V6, I, and aVL

Exclusion Criteria:

* Existing biventricular pacing system
* Permanent atrial fibrillation
* Severe renal failure with eGFR \< 30 ml/min
* AMI or CABG within the last three months
* The patient does not want to participate

Where this trial is running

Copenhagen, Hovedstaden

• Rigshospitalet — Copenhagen, Hovedstaden, Denmark (Recruiting)

Study contacts

• Principal investigator: Michael Vinther, MD PhD — Rigshospitalet, Denmark
• Study coordinator: Berit Th Philbert, MD PhD

Conditions Heart Failure; Left Bundle-Branch Block; left bundle branch block; HIS-pacing; LBB-pacing; left bundle branch pacing