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

Physiological Pacing Clinical Trial

— LEVEL-AT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04054895
• Other study ID #: LEVEL-AT
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Physiological Pacing
• Resynchronization Therapy

Intervention

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).
• 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.

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona	Select

Sponsors (3)

Lead Sponsor	Collaborator
Josep Lluis Mont Girbau	Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV), Institut d'Investigacions Biomèdiques August Pi i Sunyer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular activation time.	Left ventricular activation time measured by eletrocardiographic imaging.	45 days
Secondary	QRS duration.	QRS duration (milliseconds) measured with a 12-lead ECG.	Implant, 6 months and 12 months.
Secondary	Left ventricular activation time.	Left ventricular activation time measured by eletrocardiographic imaging	6 months and 12 months.
Secondary	Change in left ventricular function.	Left ventricular ejection fraction measured with Simpson method with echocardiography.	6 months and 12 months.
Secondary	Change in end-systolic volume.	End-systolic volume measured with echocardiography.	6 months and 12 months.
Secondary	Change in NYHA functional class.	NYHA functional class I, II, III, IV.	6 months and 12 months.
Secondary	Hospitalization due to heart failure or mortality (combined endpoint).	Hospitalization: patient hospitalization (yes/no) Mortality: mortality (yes/no)	1 year.
Secondary	Correction of septal flash	Correction of septal flash determined with echocardiography (M mode)	15 days