LEft VEntricuLar Activation Time Shortening With Physiological Pacing vs Biventricular Resynchronization Therapy (LEVEL-AT)

Josep Lluis Mont Girbau

Status: Completed

Conditions: Resynchronization Therapy; Physiological Pacing

Treatments: Device: Lead is placed in a tributary of the coronary sinus.; Device: Lead placed in the His-Purkinje system in order to achieve QRS shortening.

Study type: Interventional

Funder types: Other

Identifiers

NCT04054895

LEVEL-AT

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Physiological pacing

Experimental group

Description:

Pacing the his-purkinje system. Crossover to biventricular CRT will be allowed in the following situations: failed physiological pacing lead implantation; high thresholds (\>3.5V / 1ms); no shortening of QRS (shortening \<20%) or failure to meet non-selective HBP criteria \[Europace. 2019 Oct 9. doi: 10.1093/europace/euz275\].

Treatment:

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

Biventricular resynchronization therapy

Active Comparator group

Description:

Pacing from the right ventricular and coronary sinus leads. Electrocardiographic optimization with fusion-optimized intervals. Crossover from biventricular CRT to physiological pacing will be allowed in the following situations: coronary sinus cannot be cannulated; no lateral or posterolateral branches; or phrenic stimulation.

Treatment:

Device: Lead is placed in a tributary of the coronary sinus.