LEft VEntricuLar Activation Time Shortening With Physiological Pacing vs Biventricular Resynchronization Therapy

Josep Lluis Mont Girbau70 enrolled

Overview

The LEVEL-AT Trial (LEft VEntricuLar Activation Time Shortening with Physiological Pacing vs Biventricular Resynchronization therapy: a randomized study) is a non-inferiority study that aims to determine if physiological pacing could decrease the left ventricular activation time compared with biventricular therapy.

To date studies have showed that physiological pacing could get similar clinical and echocardiographic response to that obtained with biventricular therapy. Activation time shortening with permanent physiological pacing has not been studied. This study will randomize 70 patients to a strategy of: biventricular pacing versus physiological pacing. LEVEL-AT study will analyze the following parameters in the 2 groups: shortening of the QRS, activation time with electrocardiographic imaging, echocardiographic asynchrony and ventricular function and clinical parameters (NYHA functional class, mortality and heart failure hospitalization). Clinical, electrocardiographic, echocardiographic and electrocardiographic imaging follow-up will be performed for 1 year.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Physiological Pacing Resynchronization Therapy

Interventions

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

Physiologic pacing to achieve QRS shortening. If the patient has indication of stimulation (AV block), a backup lead will be implanted in the right ventricle. All patients will have a lead placed in the right atrium (except those that have permanent atrial fibrillation).

Lead is placed in a tributary of the coronary sinus.DEVICE

Biventricular Resynchronization Therapy is the use of a pacemaker with two endocardial leads placed in the right atrium and right ventricle. The third 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 FEVI \<=35% (Indication of cardiac resynchronization IA or IB ESC Guidelines). No indication of stimulation for AV block. * Patients with indication of resynchronization therapy for ventricular dysfunction and indication of cardiac stimulation for AV block according to ESC Guidelines (IA ESC Guidelines). * Non-left bundle branch block, QRS ≥150 and FEVI \<=35% (Indication of cardiac resynchronization IIaB ESC Guidelines). 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)

Hospital Clinic de Barcelona

Barcelona, Select, Spain

Outcomes

Primary Outcomes

Left ventricular activation time.

Left ventricular activation time measured by eletrocardiographic imaging.

Time frame: 45 days

Secondary Outcomes

QRS duration.

QRS duration (milliseconds) measured with a 12-lead ECG.

Time frame: Implant, 6 months and 12 months.

Left ventricular activation time.

Left ventricular activation time measured by eletrocardiographic imaging

Time frame: 6 months and 12 months.

Change in left ventricular function.

Left ventricular ejection fraction measured with Simpson method with echocardiography.

Time frame: 6 months and 12 months.

Change in end-systolic volume.

End-systolic volume measured with echocardiography.

Time frame: 6 months and 12 months.

Change in NYHA functional class.

NYHA functional class I, II, III, IV.

Time frame: 6 months and 12 months.

Hospitalization due to heart failure or mortality (combined endpoint).

Hospitalization: patient hospitalization (yes/no) Mortality: mortality (yes/no)

Time frame: 1 year.

Correction of septal flash

Correction of septal flash determined with echocardiography (M mode)

Time frame: 15 days

Data from ClinicalTrials.gov

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