NCT04409119

Direct HIS/LBB Pacing as an Alternative to Biventricular Pacing in Patients With HFrEF and a Typical LBBB.

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will investigate the feasibility of using direct HIS pacing or left bundle branch pacing (LBB pacing) as an alternative to biventricular pacing in patients with symptomatic heart failure and an ECG with a typical left bundle branch block pattern.

Detailed description

Biventricular pacing has for more than a decade been standard of care for patients with HFrEF, LVEF \< 35%, NYHA II-IV despite optimal medical treatment and an ECG with left bundle branch block (LBBB). However, it is not always ideal because of several drawbacks such as phrenic nerve capture, inability to reach late activated areas and many more. Direct HIS pacing can in many cases capture the left bundle and provide normal electrical activation of the left ventricle but sometimes with high pacing thresholds. Recently direct left bundle branch pacing has shown promise with synchronous activation of the left ventricle at low pacing thresholds. In the present study we randomize 150 patients in two centres to either conventional CRT (50 patients) or HIS/LBB pacing (100 patients). In the HIS/LBB arm, direct HIS-pacing is attempted first but if its not possible or the pacing threshold for capturing the left bundle branch is \> 2.5 V at 1 ms we switch to placing a LBB-lead. Power calculation for non-inferiority: With the 50 patients in the first His Alternative study (25 Biv-CRT og 25 His-CRT) we observed a fall in systolic volumes of 34% and 46% with a standard deviation of 13-16%. Using these numbers it would take at least 108 patients to be 90% sure that the lower limit of a one-sided 97.5% confidence interval (equal to a 95% two-sided confidence interval) would be over the non-inferiority limit of -10%.

Conditions

• Heart Failure
• Left Bundle-Branch Block

Interventions

Type	Name	Description
DEVICE	HIS/LBB pacing	3830 lead to HIS or LBB
DEVICE	LV pacing	LV lead in a CS branch

Timeline

• Start date: 2020-06-01
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2020-06-01
• Last updated: 2026-02-12

Locations

1 site across 1 country: Denmark