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

Not Applicable

Completed

• Conditions: Resynchronization Therapy; Physiological Pacing
• Interventions: Device: Lead placed in the His-Purkinje system in order to achieve QRS shortening.; Device: Lead is placed in a tributary of the coronary sinus.

• Registration Number: NCT04054895
• Lead Sponsor: Josep Lluis Mont Girbau

Brief 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.

Study Timeline

• Study First Submitted: 2019-08-07
• Study First Submitted QC: 2019-08-09
• Study First Posted: 2019-08-13
• Study Start: 2019-09-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-03
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physiological pacing	Lead placed in the His-Purkinje system in order to achieve QRS shortening.	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 \[Europace. 2019 Oct 9. doi: 10.1093/europace/euz275\].
Biventricular resynchronization therapy	Lead is placed in a tributary of the coronary sinus.	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.

Primary Outcome Measures

Name	Time	Method
Left ventricular activation time.	45 days	Left ventricular activation time measured by eletrocardiographic imaging.

Secondary Outcome Measures

Name	Time	Method
Change in left ventricular function.	6 months and 12 months.	Left ventricular ejection fraction measured with Simpson method with echocardiography.
Change in end-systolic volume.	6 months and 12 months.	End-systolic volume measured with echocardiography.
Hospitalization due to heart failure or mortality (combined endpoint).	1 year.	Hospitalization: patient hospitalization (yes/no) Mortality: mortality (yes/no)
Left ventricular activation time.	6 months and 12 months.	Left ventricular activation time measured by eletrocardiographic imaging
Correction of septal flash	15 days	Correction of septal flash determined with echocardiography (M mode)
QRS duration.	Implant, 6 months and 12 months.	QRS duration (milliseconds) measured with a 12-lead ECG.
Change in NYHA functional class.	6 months and 12 months.	NYHA functional class I, II, III, IV.

Trial Locations

Locations (1)

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Select, Spain