Mechanical Dyssynchrony as Selection Criterion for CRT (AMEND-CRT)
Left Ventricular Dyssynchrony, Heart Failure, Cardiomyopathy, Dilated
About this trial
This is an interventional treatment trial for Left Ventricular Dyssynchrony focused on measuring Cardiac resynchronization therapy, Heart failure, Mechanical dyssynchrony, Echocardiography, Apical rocking, Septal flash, Left ventricle
Eligibility Criteria
Inclusion Criteria:
The proposed inclusion criteria represent the minimum recommendations for CRT implantation in heart failure patients according to the ESC 2016 guidelines. In addition:
- Patient has a LVEF ≤ 35%
- Patient has a LVEDD ≥ 55mm
- Patient has been in a stable medical condition for ≥ 1 month prior inclusion
- Patient receives Optimal Medical Treatment (OMT)
- Patient underwent complete revascularization in case of ischemia
- Patients is able to understand and willing to provide a written informed consent
- Patient is 18 years or older
Exclusion Criteria:
Patients who meet any of the following criteria will not participate in the study:
- Patient suffers from ventricular arrhythmias which do not allow to acquire 3 consecutive regular beats during echocardiography (e.g. frequent VES, bigemini, …)
- Patient suffers from severe MR, or otherwise more than moderate valvular disease
- Patient suffers from unstable angina
- Patient suffers from pulmonary hypertension, other than secondary to left heart disease
- Patient has a life expectancy of less than 1 year
- Patient is pregnant or breastfeeding
Patient has either no pacemaker / ICD or has a right ventricular pacing of < 40%, and any of the following:
- Atrial fibrillation
- PR duration > 250ms
- Second or third degree atrioventricular block
- Intrinsic QRS duration < 130ms
Patient has a right ventricular pacing of > 40% and any of the following
- Sensed AV delay > 250ms
- Paced AV delay > 280ms
Sites / Locations
- University Hospital AntwerpRecruiting
- ZNA MiddelheimRecruiting
- Hospital ErasmeRecruiting
- AZ Maria MiddelaresRecruiting
- Ghent University HospitalRecruiting
- UZ LeuvenRecruiting
- AZ DamiaanRecruiting
- AZ DeltaRecruiting
- Groupements des hôpitaux de l'institut catholique de LilleRecruiting
- CHU Rennes - Pontchaillou HospitalRecruiting
- St. Vinzenz-HospitalRecruiting
- Klinika Wad Wrodzonych SercaRecruiting
- Heart Institute Nicolae StancioiuRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Treatment recommendation based on guidelines
Treatment recommendation based on mechanical dyssynchrony
Treatment of the patient assigned to this arm will be based on the current guidelines for CRT implantation, as issued by the European Society of Cardiology. All patients will receive CRT implantation, with bi-ventricular pacing ON.
Treatment of the patients assigned to this arm will be based on the presence of mechanical dyssynchrony. All patients will receive CRT implantation. Bi-ventricular pacing will be either turned ON or OFF, based on respectively the presence or absence of mechanical dyssynchrony.