Conduction System Pacing vs Biventricular Resynchronization Therapy in Systolic Dysfunction and Wide QRS: CONSYST-CRT. (CONSYST-CRT)

  • STATUS
    Recruiting
  • End date
    Jan 24, 2024
  • participants needed
    130
  • sponsor
    Hospital Clinic of Barcelona
Updated on 24 March 2022

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.

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)

Details
Condition Resynchronization Therapy, Conduction System Pacing
Treatment Biventricular pacing, Conduction system pacing, Conduction system pacing
Clinical Study IdentifierNCT05187611
SponsorHospital Clinic of Barcelona
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

The patient must indicate their acceptance to participate in the study by signing an informed consent document
The patient must be ≥ 18 years of age
Left bundle branch block, QRS ≥130 and LVEF <=35%. No indication of stimulation for AV block
Non-left bundle branch block, QRS ≥150 and LVEF <=35%
Patients with indication of resynchronization therapy for ventricular dysfunction (LVEF <40%) and indication of cardiac pacing for AV block
LVEF <=35% in NYHA class III or IV if they are in atrial fibrillation and have intrinsic QRS >=130 ms, provided a strategy to ensure biventricular capture is in place

Exclusion Criteria

Myocardial infarction, unstable angina or cardiac revascularization during the previous 3 months
Pregnancy
Participating currently in a clinical investigation that includes an active treatment
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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