Conduction system pacing vs biventricular resynchronization therapy in systolic dysfunction and wide QRS: mortality, heart failure hospitalization or cardiac transplant (CONSYST-CRT II trial).
Superiority trial that aims to study the composite endpoint consisting of all-cause mortality, cardiac transplant or heart failure hospitalization at 12-month follow-up.
Patient must indicate acceptance to participate in the study by signing an informed consent document.
Patient must be ≥ 18 years of age.
Left bundle branch block, QRS ≥130 and LVEF <=35%. No indication of stimulation for AV block.
Non-left bundle branch block, QRS ≥150 and LVEF <=35%.
Myocardial infarction, unstable angina or cardiac revascularization during the previous 3 months.
Pregnancy.
Participating currently in a clinical investigation that includes an active treatment.
Parallel
Conduction system pacing
Procedure/SurgeryConduction system pacing implant as a Resynchronization therapy.
Biventricular pacing
Procedure/SurgeryBiventricular pacing implant
Composite end-point: all-cause mortality, cardiac transplant or heart failure hospitalization.
Clinical follow-up at 12 months
Change in left ventricular ejection fraction.
Left ventricular ejection fraction measured with Simpson method with echocardiography.
Change in left ventricular end-systolic volume.
Left ventricular volumes measured with echocardiography. Simpson rule from 2- and 4-chamber apical views.
Echocardiographic response.
\>=15% decrease in left ventricular end-systolic volume
Change in NYHA functional class.
NYHA functional class I, II, III, or IV
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Hospital Clinic of Barcelona
Lead sponsor
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Collaborator
