NCT04054895

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Josep Lluis Mont Girbau · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Physiological Pacing
• Resynchronization Therapy

Interventions

Type	Name	Description
DEVICE	Lead placed in the His-Purkinje system in order to achieve QRS shortening.	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).
DEVICE	Lead is placed in a tributary of the coronary sinus.	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.

Timeline

• Start date: 2019-09-01
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2019-08-13
• Last updated: 2022-08-04

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated device study