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NCT05434962Active, not recruiting

The Left Bundle Cardiac Resynchronization Therapy Trial

A Non-inferiority Randomized Comparison Between LEFT BUNDLE Branch Area Pacing and Biventricular Pacing for Cardiac Resynchronization Therapy: The LEFT-BUNDLE-CRT Trial

Source: ClinicalTrials.gov · Last updated 17 Jul 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
176 (actual)
First submitted
16 Jun 2022
Start date
27 Jun 2022
Primary completion date
30 Jun 2025
Lead sponsor
Óscar Cano Pérez
NCT number
NCT05434962

What you commit to

  • Study type: Interventional
  • Participants enrolled: 176
  • From 27 Jun 2022 to the primary completion date, 30 Jun 2025
  • 10 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous CRT device
  • Previous PM/ICD with ventricular pacing \> 10%
  • Unstable angina, acute Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG), Percutaneous Coronary Angioplasty (PCI), valve repair or replacement within 90 days prior enrollment

Other

  • Pregnant woman
  • Permanent or long-lasting atrial fibrillation
  • Conventional pacemaker indication
  • Nonspecific IVCD (intraventricular conduction delay)
  • Indication for valve repair or replacement
  • Already included in another clinical study that could confoud the results of the present study
  • Life expectancy \< 12 months

Who the study is looking for

  • age \> 18 years
  • Class I or IIa indication for CRT according to current ESC or ACC/AHA/HRS guidelines
  • left bundle branch block according to Strauss criteria
  • Signed and dated informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hospital General Universitario de Alicante Doctor Balmis
Coordinator of this site? Confirm its status
AlicanteSpainUnknown status
Hospital Universitario Virgen de las Nieves
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GranadaSpainUnknown status
Hospital Universitario San Cecilio
Coordinator of this site? Confirm its status
GranadaSpainUnknown status
Hospital Universitario Juan Ramon Jimenez
Coordinator of this site? Confirm its status
HuelvaSpainUnknown status
Hospital Universitario de Bellvitge
Coordinator of this site? Confirm its status
L'Hospitalet de LlobregatSpainUnknown status
Hospital 12 Octubre
Coordinator of this site? Confirm its status
MadridSpainUnknown status
Hospital Universitario Puerta de Hierro
Coordinator of this site? Confirm its status
MajadahondaSpainUnknown status
Hospital Universitario Virgen de la Arrixaca
Coordinator of this site? Confirm its status
MurciaSpainUnknown status
Hospital Universitari i Politécnic La Fe
Coordinator of this site? Confirm its status
ValenciaSpainUnknown status
Hospital Clinico Universitario Lozano Blesa
Coordinator of this site? Confirm its status
ZaragozaSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.