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Conduction System Pacing vs Biventricular Resynchronization Therapy in Systolic Dysfunction and Wide QRS: CONSYST-CRT Randomized Clinical Trial.
Conduction system pacing vs biventricular resynchronization therapy in systolic dysfunction and wide QRS (CONSYST-CRT randomized clinical trial) is a non-inferiority trial that aims to study the composite endpoint consisting of all-cause mortality, cardiac transplant, heart failure hospitalizations, and left ventricular ejection fraction (LVEF) improvement \<5 points.
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 130 patients to a strategy of biventricular pacing versus conduction system pacing. CONSYST-CRT study will analyze the following parameters in the 2 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 asynchrony (septal flash). Clinical, electrocardiographic, echocardiographic follow-up will be performed for 1 year. The first 70 patients have been recruited in the context of the LEVELAT study (ClinicalTrials.gov Identifier: NCT04054895)
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Lluís Mont
Barcelona, Spain
Start Date
January 17, 2022
Primary Completion Date
July 15, 2024
Completion Date
April 1, 2025
Last Updated
July 10, 2025
130
ACTUAL participants
Conduction system pacing
DEVICE
Biventricular pacing
DEVICE
Lead Sponsor
Hospital Clinic of Barcelona
NCT06620237
NCT06488989
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