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Clinical Trial Summary

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.


Clinical Trial Description

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) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05187611
Study type Interventional
Source Hospital Clinic of Barcelona
Contact
Status Active, not recruiting
Phase N/A
Start date January 17, 2022
Completion date October 2024

See also
  Status Clinical Trial Phase
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Recruiting NCT06088927 - Long-term Outcomes of Conduction System Pacing: a National Multicenter Observational Study - NORMAND'HIS / STIMU'HIS
Recruiting NCT06241651 - CSP Versus BiVP for Heart Failure Patients With RVP Upgraded to Cardiac Resynchronization Therapy N/A
Recruiting NCT05214365 - Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy N/A