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

Clinical Prospective Randomized Trial to Evaluate the Non-inferiority of Left Bundle Branch Area Pacing vs Cardiac Resynchronization Therapy With ECG Guided AV Optimization (DA VINCI STUDY)

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07107048
Acronym
DA VINCI
Enrollment
194
Registered
2025-08-06
Start date
2025-10-30
Completion date
2027-10-30
Last updated
2025-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

lbbap, crt

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.

Detailed description

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, LBBAP provides a fast activation of the left ventricle and has shown to maintain electrical synchrony shortening the QRS and providing the correction of left bundle branch block (LBBB) by pacing beyond the block. Despite of that, it is common to find right bundle branch block (RBBB) at the electrocardiography (ECG) that represents a delay in the RV activation and interventricular dissynchrony. This finding in patients with heart failure may worsen their conditions as shown in literature. RBBB may be minimized by the resynchronization of right ventricle and left ventricle with an adequate time sequence or by the correct optimization of the atrioventricular delay for both CRT and LBBAP in order to enable fusion with intrinsic RV conduction in patients without a complete AV block. 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. Among all the echocardiographic modalities, the mitral inflow velocity time integral (VTI) is a surrogate for LV filling volume assuming a constant mitral valve area. Mitral inflow is dependent on timing of both left atrial and left ventricular systole, and interatrial and interventricular conduction delays will affect optimal timing of ventricular pacing. 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.

Interventions

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.

Sponsors

National association Cardiovascular innovation
CollaboratorUNKNOWN
Leonardo Calò, MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* • Women who are pregnant, lactating, or plan to become pregnant during the trial. * 3rd 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. * Participants who do not anticipate being a resident of the area for the scheduled duration of the trial.

Design outcomes

Primary

MeasureTime frameDescription
CRT response6 monthsCRT RESPONSE WILL BE DEFINED: * Freedom from HF Hospitalizations * Freedom from Cardiac Death * Reverse remodeling: ≥15% relative reduction in left ventricular end-systolic volume

Countries

Italy

Contacts

Primary ContactLeonardo Calò, MD
leonardocalo.doc@gmail.com06231881

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026