An interventional study of Cardiac resynchronization therapy in Left Bundle-Branch Block, Heart Failure and Impaired Left Ventricular Function, sponsored by Óscar Cano Pérez. Active, not recruiting at 10 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-17.
Sponsored by Óscar Cano Pérez · Not applicable, Interventional, and Treatment
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.
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 in the right atrium or ventricle. It is also designed for pacing and sensing in the bundle as an alternative to pacing in the right ventricle in a single or dual chamber pacing system.
Intended use: Patients with an indication for cardiac resynchronization therapy.
Duration of the study: Approximate inclusion period of 18 months
Follow-up: Patients will be followed for 12 months ± 4 weeks after implant
Planned study period: The study is planned to start in Q1 2022
No. of sites: Approximately 11 sites in Spain.
No. of subjects: 176 patients will be enrolled in the study
Study type: Post-market study
Study rationale: Previous studies show 85% implantation success, significant reduction in QRS duration, and significant improvement in NYHA functional class, LVEF, and LV end-diastolic diameter. Left bundle branch pacing could be an alternative to conventional biventricular pacing.
Study design: Multicenter, prospective, randomized, non-inferiority, open.
Objectives of the study:
Primary Outcome Measures: Improved Clinical Composite Score or ≥15% reduction in left ventricular end-systolic volume at 6 months follow-up.
Participating sites:
Study population: Subjects 18 years of age or older will be included in the study. Both sexes are eligible to participate. Subjects must present a left bundle branch block (according to Strauss criteria) with indication of CRT class I or IIa according to clinical practice guidelines. A selection of the subjects will be made before inclusion following the selection clinical investigation plan. After confirming that the subject meets the inclusion criteria and does not meet the exclusion criteria, they will be included in the clinical study.
Study population criteria:
Device Implantation Procedure: CRT obtained by biventricular pacing vs. CRT obtained by stimulating the left branch area.
Follow-up: Follow-up should be carried out with pre-established periodic clinical appointments 3, 6, and 12 months after hospital discharge. In the follow-up, routine examinations such as vital signs, electrocardiogram and echocardiogram (6 and 12 months) are recorded to check the evaluation of the reverse ventricular remodeling response and asynchrony parameters based on echocardiographic data.
Statistical considerations: Once patients have signed the informed consent at baseline visit, patients will be considered as "Enrolled population" in the statistical analysis. The sample size is based on the primary endpoint: Improved Clinical Composite Score or ≥15% reduction in left ventricular end-systolic volume at 6 months follow-up, showing that LBBAP is non-inferior to BiV-CRT. Accounting for a global attrition rate of 10% and considering the block size for randomization, 176 patients shall be enrolled.
94 studies on the registry are indexed under Bundle-Branch Block; 30 are open to participants now.
This study's enrollment of 176 is above the median of 60 across 59 interventional studies indexed under Bundle-Branch Block.
Browse Bundle-Branch Block studies →Óscar Cano Pérez is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
CRT response
Positive CRT response will be defined either by an improved Clinical Composite Score or ≥15% reduction in left ventricular end-systolic volume
Time frame: 6 months follow-up
Left ventricular ejection fraction
To evaluate left ventricular ejection fraction at 6 and 12 months follow-up
Time frame: 6 and 12 months follow-up
Clinical outcome
Assessed by the Clinical Composite Score
Time frame: 6 and 12 months follow-up
Exercise capacity
Assessed by 6 minute walking test
Time frame: 6 and 12 months follow-up
The EQ-5D three-level version (EQ-5D-3L)
Is a generic measure of health status consisting of 2 parts. The first assesses health in five dimensions (mobility, selfcare, usual activities, pain / discomfort, anxiety / depression), each of which has 3 levels of response (no problems, some problems, extreme problems / unable to). This part of the questionnaire provides a descriptive profile that can be used to generate a health state profile. Each health state can potentially be assigned a summary index score based on societal preference weights for the health state. Health state index scores generally range from less than 0 (where 0 is a health state equivalent to death; negative values are valued as worse than death) to 1 (perfect health), with higher scores indicating higher health utility. The second part consists of a VAS on which the patient rates his / her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health)
Time frame: 6 and 12 months follow-up
Heart Failure Hospitalizations
Assessment of heart failure hospitalizations
Time frame: 6 and 12 months follow-up
Mortality
To evaluate mortality (global and cardiovascular)
Time frame: 6 and 12 months follow-up
Cardiac transplantation
To evaluate the need for cardiac transplantation during follow-up
Time frame: 6 and 12 months follow-up
Ventricular arrhythmias
To evaluate incidence of ventricular arrhythmias (clinical and registered by the ICD/PM)
Time frame: 6 and 12 month follow-up
Device related complications
Device related complications needing re-intervention
Time frame: 6 and 12 month follow-up
Plan to share: No
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This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Óscar Cano Pérez