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.
To date, studies have shown that conduction system pacing could get similar clinical and echocardiographic responses to those obtained with biventricular therapy. This study will randomize 320 patients to a strategy of biventricular pacing versus conduction system pacing. CONSYST-CRT II study will analyze a clinical endpoint as primary endpoint and the following parameters in both groups: left ventricular ejection fraction, ventricular volumes, echocardiographic response (\>=15% decrease in left ventricular end-systolic volume), NYHA functional class, heart failure hospitalization, all-cause mortality, cardiac transplant, QRS shortening, echocardiographic dyssynchrony (atrioventricular, interventricular, intraventricular) and global longitudinal strain. As a secondary endpoint, baseline predictors of response to conduction system pacing and biventricular pacing according to cardiac magnetic ressonance and electrocardiographic imaging will be studied. Clinical, electrocardiographic, echocardiographic follow-up will be performed during 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
320
Conduction system pacing implant as a Resynchronization therapy.
Biventricular pacing implant
Hospital Clínic de Barcelona
Barcelona, Spain
RECRUITINGComposite end-point: all-cause mortality, cardiac transplant or heart failure hospitalization.
Clinical follow-up at 12 months
Time frame: 1 year
Change in left ventricular ejection fraction.
Left ventricular ejection fraction measured with Simpson method with echocardiography.
Time frame: 6 months; 1 year
Change in left ventricular end-systolic volume.
Left ventricular volumes measured with echocardiography. Simpson rule from 2- and 4-chamber apical views.
Time frame: 6 months; 1 year
Echocardiographic response.
\>=15% decrease in left ventricular end-systolic volume
Time frame: 6 months; 1 year
Change in NYHA functional class.
NYHA functional class I, II, III, or IV
Time frame: 6 months; 1 year
QRS shortening.
QRS duration (milliseconds). QRS onset measured from fast deflection and from spike.
Time frame: Immediately after the intervention
Correction of septal flash.
Fast inward-outward movement of the interventricular septum in early systole. Using M-mode in parasternal short and long-axis views, septal flash was quantified (in millimeters) as the highest amplitude of the early inward motion measured from the resting position prior to the onset of septal contraction. The pair of septal flash measures (baseline and final) was obtained at the axis with the highest baseline SF.
Time frame: 15 days; 6 months; 1 year
Correction of auriculoventricular dyssynchrony.
Left ventricular filling time. The left ventricular filling time was measured from the onset of the E-wave to the end of the A-wave, and the R-R interval was measured to calculate the percentage of filling time relative to the cardiac cycle (LV filling time/RR, %).
Time frame: 15 days; 6 months; 1 year
Correction of interventricular dyssynchrony.
Quantified using pulsed Doppler and calculated as the time difference between QRS onset and the onset of the flow wave in the right and left outflow tracts.
Time frame: 15 days; 6 months; 1 year
Change in global longitudinal strain (GLS).
Strain myocardial deformation of the left ventricle was quantified offline from 2-dimensional echocardiography using speckle tracking (2Dstrain, Echo Pac, version 202.41.0, GE Healthcare Milwaukee, WI). The long-axis cine images (2-, 3-, and 4-chamber views), were used to determine GLS.
Time frame: 15 days; 6 months; 1 year
Description of baseline predictors of response to conduction system pacing and biventricular pacing. Cardiac fibrosis quantification.
Cardiac fibrosis quantification (grams of fibrosis)
Time frame: Baseline (pre intervention).
Description of baseline predictors of response to conduction system pacing and biventricular pacing with Electrocardiographic Imaging. Left ventricular activation time (LVAT), ms.
Left ventricular activation time (LVAT), ms.
Time frame: Baseline (pre intervention). And immediately after the intervention
Description of baseline predictors of response to conduction system pacing and biventricular pacing with Electrocardiographic Imaging. Ventricular electrical uncoupling (VEU).
Ventricular electrical uncoupling (VEU) = mean left ventricular activation time - mean right ventricular activation time, ms
Time frame: Baseline (pre intervention). And immediately after the intervention
Description of baseline predictors of response to conduction system pacing and biventricular pacing with Electrocardiographic Imaging. Left ventricular dyssynchrony index (LVDI).
Left ventricular dyssynchrony index (LVDI): standard deviation of individual activations recorded from the left ventricle.
Time frame: Baseline (pre intervention). And immediately after the intervention
Description of baseline predictors of response to conduction system pacing and biventricular pacing with Electrocardiographic Imaging. Conduction velocity (cm/s).
Conduction velocity (cm/s).
Time frame: Baseline (pre intervention). And immediately after the intervention
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