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.
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 the investigators 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 the investigators 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) the investigators 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%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
3830 lead to HIS or LBB
LV lead in a CS branch
Hammersmith Hospital
London, United Kingdom
RECRUITINGChange in Left ventricular end-systolic volume
Echocardiographic response after 6 months defined as decrease in left ventricular systolic volume of ≥ 15% of baseline
Time frame: 6 months
Success rate of implanting a HIS-bundle lead with capture of the left bundle branch or a LBB-lead with narrowing of QRS
The success rate of implanting a pacing lead to the HIS-bundle with capture of the left bundle at a threshold \< 2.5 V at 1 ms or implantation of a LBB lead with narrowing of the QRS duration and maintaining this effect at 6 month follow-up
Time frame: 6 months
Change in LVEF and left ventricular chamber dimensions
Echocardiographic response assessed by chamber dimensions and LVEF on a continuous scale
Time frame: 6 months
Change in 6-min hall-walk test
Functional response after 6 months defined as an increase in 6-min walking distance of ≥ 20% of the initial value
Time frame: 6 months
Change in NYHA class
Symptomatic response after 6 months defined as a fall in NYHA class of ≥ 1
Time frame: 6 months
Change in Minnesota Living with Heart Failure score
Change in well-being after 6 months defined as a decrease in Minnesota Living With Heart Failure score of ≥ 15% of baseline
Time frame: 6 months
Shortening of QRS duration
Shortening the duration of the QRS complex defined as the widest paced QRS complex rated at 12-lead ECG after 6 months
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Time frame: 6 months
Change in NT-pro BNP value
Change in NT-pro BNP value
Time frame: 6 months
Complications
Device-related complications (periprocedural: electrode reoperation, pneumothorax, hemothorax, pericardial bleeding/tamponade and later (after 30 days post implantation): LV/HIS electrode reoperation, change of device due to battery depletion and infection requiring extraction).
Time frame: 6 months