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
- Diseases
- Heart failure
- 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
Sites (10)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital General Universitario de Alicante Doctor Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Unknown status |
| Hospital Universitario Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Unknown status |
| Hospital Universitario San Cecilio Coordinator of this site? Confirm its status | Granada | Spain | Unknown status |
| Hospital Universitario Juan Ramon Jimenez Coordinator of this site? Confirm its status | Huelva | Spain | Unknown status |
| Hospital Universitario de Bellvitge Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Unknown status |
| Hospital 12 Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Puerta de Hierro Coordinator of this site? Confirm its status | Majadahonda | Spain | Unknown status |
| Hospital Universitario Virgen de la Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Unknown status |
| Hospital Universitari i Politécnic La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.