Status:
COMPLETED
LEft VEntricuLar Activation Time Shortening With Physiological Pacing vs Biventricular Resynchronization Therapy
Lead Sponsor:
Josep Lluis Mont Girbau
Collaborating Sponsors:
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV)
Conditions:
Physiological Pacing
Resynchronization Therapy
Eligibility:
All Genders
18+ years
Phase:
NA
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 determ...
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 p...
Eligibility Criteria
Inclusion
- 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
- Myocardial infarction, unstable angina or cardiac revascularization during the previous 3 months.
- Pregnancy.
- Participating currently in a clinical investigation that includes an active treatment.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04054895
Start Date
September 1 2019
End Date
June 30 2022
Last Update
August 4 2022
Active Locations (1)
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1
Hospital Clinic de Barcelona
Barcelona, Select, Spain, 08036