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

Hospital Clinic of Barcelona130 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

130

Conditions

Resynchronization Therapy Conduction System Pacing

Interventions

Conduction system pacingDEVICE

Lead placed in the His-Purkinje system in order to achieve QRS shortening.

Biventricular pacingDEVICE

Lead is placed in a tributary of the coronary sinus.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Lluís Mont

Barcelona, Spain

Outcomes

Primary Outcomes

Composite end-point: all-cause mortality, cardiac transplant, heart failure hospitalization, and left ventricular ejection fraction (LVEF) improvement <5 points.

Non inferiority margin 10%.

Time frame: 12 months

Secondary Outcomes

Change in left ventricular ejection fraction.

Non inferiority margin 2.5%

Time frame: 6 months; 12 months

Change in left ventricular end-systolic volume.

Non inferiority margin 3%

Time frame: 6 months; 12 months

Echocardiographic response (>=15% decrease in left ventricular end-systolic volume).

Non inferiority margin 10%

Time frame: 6 months; 12 months

Hospitalization due to heart failure, mortality or cardiac transplant (combined endpoint)

Non inferiority margin 10%

Time frame: 6 months; 12 months

QRS shortening

Non inferiority margin 12ms

Time frame: Post-implantation (Electrophysiology Lab)

Correction of septal flash

Non inferiority margin 0.5mm

Time frame: 15 days; 6 months; 12 months

Change in NYHA functional class

NYHA functional class I, II, III, IV.

Time frame: 6 months; 12 months

Data from ClinicalTrials.gov

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