Clinical trial NCT04054895: LEft VEntricuLar Activation Time Shortening With Physiological Pacing vs Biventricular Resynchronization Therapy
Official title: LEft VEntricuLar Activation Time Shortening With Physiological Pacing vs Biventricular Resynchronization Therapy: a Randomized Study (LEVEL-AT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physiological Pacing
Resynchronization Therapy
Keywords: Physiological pacing
Resynchronization therapy
Electrocardiographic imaging
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Institut d'Investigacions Biomèdiques August Pi i Sunyer
name: Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV)
First posted: 2019-08-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, unicentric, simple blind.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Left ventricular activation time.
timeFrame: 45 days
Secondary outcomes:
measure: QRS duration.
timeFrame: Implant, 6 months and 12 months.
measure: Left ventricular activation time.
timeFrame: 6 months and 12 months.
measure: Change in left ventricular function.
timeFrame: 6 months and 12 months.
measure: Change in end-systolic volume.
timeFrame: 6 months and 12 months.
measure: Change in NYHA functional class.
timeFrame: 6 months and 12 months.
measure: Hospitalization due to heart failure or mortality (combined endpoint).
timeFrame: 1 year.
measure: Correction of septal flash
timeFrame: 15 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
state: Select
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Jose M Tolosana, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic of Barcelona
name: Margarida Pujol Lopez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic of Barcelona
name: Lluis Mont Girbau, MD, PhD
role: STUDY_DIRECTOR
References: