Clinical Prospective ranDomized Trial to Evaluate the Non-inferiority of Left Bundle Branch Area Pacing Vs Cardiac ResynchronIzatioN Therapy With ECG guIded AV Optimization

NCT07107048 | Not Yet Recruiting

• 1 other identifier: v1 7jul25
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac resynchronization therapy is the gold standard therapy for patients with advanced HF left ventricle dysfunction and large QRS. Recently left bundle branch area pacing (LBBAP) or left bundle optimized cardiac resynchronization therapy has been proposed as a rescue therapy for failed or unsuccessful CRT. LBBAP has been also proposed as a physiological pacing modality for patient who need permanent ventricular pacing as an alternative to conventional right ventricular pacing. Several observational studies have demonstrated the feasibility of this technique due to an ease procedure, stable and appropriate electrical measurements and clinical benefit in terms of patients outcomes. Furthermore, It is well known that an optimized AV delay (AVD) can improve clinical outcomes preserving a physiological diastolic function. In clinical practice several different AVD optimization methods have been developed in the last few years. The majority of them use the intracardiac electrograms during the implant procedure to evaluate QRS duration and AV delay or at follow-up through echocardiographic measurements. Aim of our pilot project is to assess the non-inferiority of Left Bundle Branch Area Pacing vs Cardiac Resynchronization Therapy with ECG/Echo guided AV optimization.

Conditions

Heart Failure

Keywords

lbbap; crt

Outcome Measures

Primary Outcomes (1)

• CRT response

  CRT RESPONSE WILL BE DEFINED: * Freedom from HF Hospitalizations * Freedom from Cardiac Death * Reverse remodeling: ≥15% relative reduction in left ventricular end-systolic volume

  6 months

Study Arms (2)

LBBAP

EXPERIMENTAL

Patients undergoing left bundle branch area pacing (LBBAP) implantation

Device: Pacemaker and defibrillator

CRT Biv

ACTIVE COMPARATOR

Patients undergoing cardiac resynchronization therapy (CRT) with biventricular pacing

Device: Pacemaker and defibrillator

Interventions

Pacemaker and defibrillator DEVICE

Patients will be randomly assigned at enrollment (1:1) to undergo either LBBAP or CRT with biventricular stimulation. The devices implanted maybe defibrillators or pacemekers.

CRT Biv; LBBAP

Eligibility Criteria

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

You may qualify if:

• Patients with indications of cardiac resynchronization therapy
• Patients with Left Branch Block (LBBB) (2021 ESC/REVERSE. Glickson et al \_EHJ 2021):
• Patients over 18 years of age.

You may not qualify if:

• Women who are pregnant, lactating, or plan to become pregnant during the trial.
• rd degree AV Block
• Participants with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary, intervention in the next three (3) months.
• Enzyme-positive myocardial infarction within the past three (3) months prior to enrollment.
• Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within the past three (3) months prior to enrollment.
• Reversible non-ischemic cardiomyopathy (e.g., acute viral myocarditis).
• Participants with Chagas disease, cardiac sarcoidosis or amyloidosis.
• Expected to receive left ventricular assist device or heart transplantation within 6 months.
• Participants with severe valvular disease (e.g., aortic stenosis).
• Have a life expectancy of less than 12 months.
• Participants with irreversible brain damage from preexisting cerebral disease.
• Participants with a contrast dye allergy unable or unwilling to undergo pretreatment with steroids and/or diphenhydramine.
• Long-lasting or permanent atrial fibrillation
• Participants participating in any other interventional cardiovascular clinical trial.
• Participants who would be unable to return for follow-up visits due to the distance from the clinic.

Sponsors & Collaborators

• Leonardo Calò, MD: lead
• National association Cardiovascular innovation: collaborator

Study Sites (1)

Policlinico Casilino

Rome, Italy

Location

MeSH Terms

Conditions

Heart Failure; Creatine deficiency, X-linked

Interventions

Defibrillators

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electrodes; Electrical Equipment and Supplies; Equipment and Supplies

Central Study Contacts

Leonardo Calò, MD

CONTACT

06231881; leonardocalo.doc@gmail.com

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: Prof.

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)