HIS Alternative II
His-Alternative II — 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
Paciente / Población Intervención / Exposición Comparación Desenlace
In 150 patients with HFrEF and left bundle branch block, conduction-system pacing was compared with biventricular pacing on the change in LV end-systolic volume at 6 months.
N
150
Diseño
Investigator-initiated, multicentre (Rigshospitalet, Copenhagen; Imperial College Healthcare NHS Trust, London), randomised 1:2 (biventricular CRT : conduction-system-pacing CRT) non-inferiority trial; patients and echocardiography/6-minute-walk assessors blinded; in the CSP arm His-bundle pacing is attempted first, then left bundle branch pacing, with a coronary-sinus LV lead as bail-out (and vice versa in the control arm); 6-month follow-up; enrolment June 2020 to February 2026.
Desenlace
Change in left ventricular end-systolic volume by echocardiography at 6 months (non-inferiority versus biventricular CRT); the registry also lists the success rate of His-bundle or LBB lead implantation with LBBB correction as a co-primary