Electrophysiological Optimization of Left Ventricular Lead Placement in CRT (ElectroCRT)
Congestive Heart Failure
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring Cardiac Resynchronization Therapy, Heart Failure, Ejection Fraction, Narrow, Pacemaker, Electrophysiology, Electrical activation mapping, Coronary Sinus, Mapping, QRS, QRS width, Pacing Interval, Left Ventricular Lead, Cardiac CT, Echocardiography, Myocardial Scintigraphy, 6 Minutes Walk Test, Imaging, Left ventricular ejection fraction, Epicardial veins, Resynchronization, ImagingCRT, Optimal electrical resynchronization, Cardiac computed tomography
Eligibility Criteria
Inclusion Criteria:
- Symptomatic heart failure (New York Heart Association (NYHA) functional class II - IV) despite optimal medical therapy
- ECG with left bundle branch block and QRS ≥ 120 ms
- LVEF ≤ 35 %
- Age > 40 years
- Written informed consent Patients with an indwelling single- or dual chamber pacemaker and a paced QRS > 180 ms are eligible for enrollment.
Exclusion Criteria:
- Expected lifetime < 6 months
- Expected heart-surgery within the next 6 months
- Recent (< 3 months) myocardial infarction or coronary artery bypass graft (CABG)
- Pregnant or lactating
- No written informed consent Cardiac CT will not be performed in patients where this is contraindicated, i.e. in the presence of depressed renal function (estimated Glomerular Filtration Rate (eGFR) < 30 ml (milliters)/minute), thyrotoxicosis or in the case of former serious reactions to the contrast media.
Sites / Locations
- Aarhus University Hospital, Skejby, Department of Cardiology
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Optimal electrical resynchronization
Routine CRT-strategy, imaging guided
Cardiac Resynchronization Therapy: LV lead implant according to electrical activation mapping of available epicardial veins to identify the latest electrical activated myocardial region. Post-implant interventricular (VV) electrical optimization for narrowing the paced QRS width. Post-implant standard pacemaker settings: Atrioventricular (AV) interval 100-130 ms and VV interval settings with simultaneous biventricular pacing. Day 1 after implantation: ECG, AV-optimization guided by echocardiography, high-pitch cardiac CT to verify LV lead position. Programming of the VV interval to obtain the narrowest QRS-width
Cardiac Resynchronization Therapy: LV lead implant guided by echocardiography and Rb-PET towards the latest mechanically activated myocardial segment and separate from scar. Post-implant VV electrical optimization for narrowing the paced QRS width. Standard pacemaker settings for both groups: AV-interval 100-130 ms and VV-interval settings with simultaneous biventricular pacing. Day 1 after implantation: ECG, AV-optimization guided by echocardiography, high-pitch cardiac CT to verify LV lead position. Continue standard interventricular pacing interval settings with simultaneous pacing in both ventricular leads.