The Left Bundle Cardiac Resynchronization Therapy Trial

NCT05434962 | Active Not Recruiting DMC

• 1 other identifier: LB-CRT-001
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 10

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 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.

Conditions

Left Bundle-Branch Block; Heart Failure; Impaired Left Ventricular Function

Keywords

cardiac resynchronization therapy; conduction ssystem pacing

Outcome Measures

Primary Outcomes (1)

• CRT response

  Positive CRT response will be defined either by an improved Clinical Composite Score or ≥15% reduction in left ventricular end-systolic volume

  6 months follow-up

Secondary Outcomes (9)

• Left ventricular ejection fraction

  6 and 12 months follow-up

• Clinical outcome

  6 and 12 months follow-up

• Exercise capacity

  6 and 12 months follow-up

• The EQ-5D three-level version (EQ-5D-3L)

  6 and 12 months follow-up

• Heart Failure Hospitalizations

  6 and 12 months follow-up

Study Arms (2)

Cardiac resynchronization therapy (CRT) obtained by stimulating the left branch area

EXPERIMENTAL

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. It is strongly encouraged the designation of a single and experienced implanting physician at each center for the LBBAP implant procedures. 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.

Device: Cardiac resynchronization therapy

Cardiac resynchronization therapy (CRT) obtained by biventricular pacing

ACTIVE COMPARATOR

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. Investigators may use any market approved right atrial (RA) pace/sense lead, right ventricular (RV) pacing/defibrillator lead with pace/sense capabilities and any market approved unipolar/bipolar/quadripolar LV pacing lead. During the implant procedure lead impedances, pacing and sensing parameters will be measured using a pacing system analyzer (PSA). 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

Device: Cardiac resynchronization therapy

Interventions

Cardiac resynchronization therapy DEVICE

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

Cardiac resynchronization therapy (CRT) obtained by biventricular pacing; Cardiac resynchronization therapy (CRT) obtained by stimulating the left branch area

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Óscar Cano Pérez: lead
• Spanish Society of Cardiology: collaborator

Study Sites (10)

Hospital General Universitario de Alicante Doctor Balmis

Alicante, Alicante, Spain

Location

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, Granada, 18014, Spain

Location

Hospital Universitario San Cecilio

Granada, Granada, 18016, Spain

Location

Hospital Universitario Juan Ramón Jiménez

Huelva, Huelva, 21005, Spain

Location

Hospital 12 Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Universitario Puerta De Hierro

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario Virgen de la Arrixaca

Murcia, Murcia, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, Valencia, 46026, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Bundle-Branch Block; Heart Failure; Ventricular Dysfunction, Left

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ventricular Dysfunction

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Cardiologist

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 28, 2022
• Study Start: June 27, 2022
• Primary Completion: June 30, 2025
• Study Completion: August 31, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (10)