LEft VEntricuLar Activation Time Shortening With Physiological Pacing vs Biventricular Resynchronization Therapy: a Randomized Study (LEVEL-AT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Left ventricular activation time.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
The patient will be explained to be randomized to either of the two branches. The type of therapy applied will not be communicated to the patient. The follow-up will be the same in the two branches. During the visits it will not be said which therapy has been applied.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Physiological pacing
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].
Intervention: Lead placed in the His-Purkinje system in order to achieve QRS shortening. (Device)
Biventricular resynchronization therapy
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.
Intervention: Lead is placed in a tributary of the coronary sinus. (Device)
Outcomes
Primary Outcomes
Left ventricular activation time.
Time Frame: 45 days
Left ventricular activation time measured by eletrocardiographic imaging.
Secondary Outcomes
- Change in end-systolic volume.(6 months and 12 months.)
- Hospitalization due to heart failure or mortality (combined endpoint).(1 year.)
- Correction of septal flash(15 days)
- Left ventricular activation time.(6 months and 12 months.)
- Change in left ventricular function.(6 months and 12 months.)
- QRS duration.(Implant, 6 months and 12 months.)
- Change in NYHA functional class.(6 months and 12 months.)
Investigators
Josep Lluis Mont Girbau
Head of Arrhythmia Section. Professor of Cardiology
Hospital Clinic of Barcelona