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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
Sponsor: Leonardo Calò, MD
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
194
Start Date
2025-10-30
Completion Date
2027-10-30
Last Updated
2025-08-06
Healthy Volunteers
No
Conditions
Interventions
Pacemaker and defibrillator
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.
Locations (1)
Policlinico Casilino
Rome, Italy