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

  • STATUS
    Recruiting
  • End date
    Jan 1, 2024
  • participants needed
    125
  • sponsor
    Rigshospitalet, Denmark
Updated on 15 August 2021
heart failure
cardiomyopathy
left bundle branch block
crt-p
atrio-biventricular pacing

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.

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 125 patients in one center to either conventional CRT (45 patients) or HIS/LBB pacing (80 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%.

Details
Condition cardiac failure, Cardiac Disease, Heart Failure, left bundle branch block, Right bundle branch block, Heart disease, Heart failure, congestive heart disease, lbbb, Heart Disease, Congestive Heart Failure
Treatment LV pacing, HIS/LBB pacing
Clinical Study IdentifierNCT04409119
SponsorRigshospitalet, Denmark
Last Modified on15 August 2021

Eligibility

Yes No Not Sure

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
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
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