Cardiac Resynchronization Therapy, Non-LBBB, QRS Area Clinical Trial
Official title:
MARC-2: MARKERS AND RESPONSE TO CRT in Non-LBBB
The purpose of the MARC-2 study is to investigate the relation of the QRS area, determined by
vectorcardiography, and response to Cardiac Resynchronization Therapy (CRT) in patients with
a wide QRS complex and without a typical left bundle branch block; the interrelationship as
well as the potential predictive power of this biomarker, as well as other clinical
biomarkers on a hierarchal composite endpoint (death, heart failure hospitalizations, heart
failure complaints and cardiac function) will be evaluated.
The main biomarker that is studied is the QRS area, but also other electrocardiographic,
echocardiographic markers, blood markers and clinical markers will be studied.
For the purpose described in the brief summary, the MARC-2 study investigators have set an aim of including 800 patients in 2 inclusion years, in 30 centres accross Europe and Israel. Inclusion will be general patients indicated for (de novo or upgrade) implantation a (Medtronic) CRT-pacemaker or -ICD, as according to current ESC heart failure guidelines. Exclusion criteria are, age below 18 years, (planning) childbearing, baseline > 5% RV-pacing, listing for transplantation or inotropic dependency, structural heart disease for which invasive therapy is pending, or inability/unwillingness to sign written informed consent. All QRS morphologies, with duration >/= 130ms are included because multiple LBBB definitions exist and excluding patients on one definition will leave room for questions about the definitions used. (Bio)markers that are collected are electrocardiographic/vectorcardiographic/echocardiographic/blood-/CMR/ and device-based parameters that have shown prior association to outcomes in CRT, with special attention to vectorcardiographic QRS area. The primary endpoint will be a hierarchal (Packer) score of collected heart failure related endpoints including death/LVAD/cardiac transpland/heart failure hospitalizations/echocardiographic remodelling and NYHA improvement. Follow-up for clinical endpoints will be 12 months; with echocardiographic follow-up at 6 months. Clinical endpoints are subject to adjudication committee assessment. Core-labs exist to assess electrocardiographic, echocardiographic and CMR-data. ;