Clinical Research Directory
Browse clinical research sites, groups, and studies.
The Left Bundle Cardiac Resynchronization Therapy Trial
Sponsor: Óscar Cano Pérez
Summary
Cardiac resynchronization therapy (CRT) via biventricular (BiV) pacing significantly reduces morbidity and mortality in patients with left bundle branch block (LBBB), impaired LV function and heart failure in spite of optimal medical treatment. CRT positive effects are based on the existence of an electromechanical dyssynchrony induced by the abnormal activation sequence associated with the presence of a left bundle branch block (LBBB), which is thought to be responsible for a negative LV remodeling leading to LVEF impairment and heart failure progression. However, one third of patients undergoing CRT are considered non responders due to different reasons. Recently, left bundle branch area pacing (LBBAP) has emerged as a novel physiological pacing modality aiming for conduction system recruitment in patients with normal or impaired atrioventricular conduction, including patients with LBBB. LBBAP achieves LBBB correction in up to 85% of the cases and thus could be a promising pacing modality for CRT candidates.
Official title: A Non-inferiority Randomized Comparison Between LEFT BUNDLE Branch Area Pacing and Biventricular Pacing for Cardiac Resynchronization Therapy: The LEFT-BUNDLE-CRT Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
176
Start Date
2022-06-27
Completion Date
2025-08-31
Last Updated
2025-07-17
Healthy Volunteers
No
Interventions
Cardiac resynchronization therapy
Standard BiV-CRT The CRT-P/CRT-D device and leads should be implanted according to the physician's manual provided with the devices. Only locally approved Medtronic CRT-P/CRT-D generators will be used during the study. The LV lead should be implanted at a lateral or posterolateral CS branch in a basal or mid ventricular position confirmed by ortogonal fluoroscopic views (RAO and LAO 40º). Acceptable LV pacing threshold should be \<3V@0,5ms and phrenic nerve stimulation (PNS) margin should be \>1V with respect to the pacing threshold. LBBAP-CRT The CRT-P/CRT-D device and leads should be implanted according to the physician's standard practice. Only locally approved Medtronic CRT-P/CRT-D generators will be used during the study. During the implant procedure lead impedances, pacing and sensing parameters will be measured using a pacing system analyzer (PSA). For LBBAP, the Medtronic 3830 lead will be used. Acceptable LBBAP threshold should be \<2,5V@0,5ms
Locations (10)
Hospital General Universitario de Alicante Doctor Balmis
Alicante, Alicante, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Virgen de las Nieves
Granada, Granada, Spain
Hospital Universitario San Cecilio
Granada, Granada, Spain
Hospital Universitario Juan Ramón Jiménez
Huelva, Huelva, Spain
Hospital 12 Octubre
Madrid, Madrid, Spain
Hospital Universitario Puerta De Hierro
Majadahonda, Madrid, Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, Murcia, Spain
Hospital Universitari i Politècnic La Fe
Valencia, Valencia, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Zaragoza, Spain