The Left Bundle Cardiac Resynchronization Therapy Trial

NAActive, not recruitingINTERVENTIONAL
Enrollment

176

Participants

Timeline

Start Date

June 27, 2022

Primary Completion Date

June 30, 2025

Study Completion Date

August 31, 2025

Conditions
Left Bundle-Branch BlockHeart FailureImpaired Left Ventricular Function
Interventions
DEVICE

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"

Trial Locations (10)

18014

Hospital Universitario Virgen de las Nieves, Granada

18016

Hospital Universitario San Cecilio, Granada

21005

Hospital Universitario Juan Ramón Jiménez, Huelva

28041

Hospital 12 Octubre, Madrid

28222

Hospital Universitario Puerta De Hierro, Majadahonda

46026

Hospital Universitari i Politècnic La Fe, Valencia

50009

Hospital Clínico Universitario Lozano Blesa, Zaragoza

Unknown

Hospital General Universitario de Alicante Doctor Balmis, Alicante

Hospital Universitario Virgen de la Arrixaca, Murcia

08907

Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat

All Listed Sponsors
collaborator

Spanish Society of Cardiology

OTHER

lead

Óscar Cano Pérez

OTHER