Status:
ACTIVE_NOT_RECRUITING
The Left Bundle Cardiac Resynchronization Therapy Trial
Lead Sponsor:
Óscar Cano Pérez
Collaborating Sponsors:
Spanish Society of Cardiology
Conditions:
Left Bundle-Branch Block
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 fa...
Detailed Description
Medical device: Only CE-marked CRT-P or CRT-D Medtronic devices locally approved and commercially available (Medtronic 3830 Pacing Lead) shall be used in this protocol. Indication: Pacing and sensing...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Pregnant woman
- Permanent or long-lasting atrial fibrillation
- Previous CRT device
- Previous PM/ICD with ventricular pacing \> 10%
- Conventional pacemaker indication
- Nonspecific IVCD (intraventricular conduction delay)
- Unstable angina, acute Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG), Percutaneous Coronary Angioplasty (PCI), valve repair or replacement within 90 days prior enrollment
- 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
Key Trial Info
Start Date :
June 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2025
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT05434962
Start Date
June 27 2022
End Date
August 31 2025
Last Update
July 17 2025
Active Locations (10)
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1
Hospital General Universitario de Alicante Doctor Balmis
Alicante, Alicante, Spain
2
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
3
Hospital Universitario Virgen de las Nieves
Granada, Granada, Spain, 18014
4
Hospital Universitario San Cecilio
Granada, Granada, Spain, 18016