NCT07107048Not yet recruiting
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)
Source: ClinicalTrials.gov · Last updated 6 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 194 (estimated)
- First submitted
- 30 Jul 2025
- Start date
- 30 Oct 2025
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Leonardo Calò, MD
- Diseases
- Heart failure
- NCT number
- NCT07107048
What you commit to
- Study type: Interventional
- Planned participants: 194
- From 30 Oct 2025 to the primary completion date, 30 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- • 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Policlinico Casilino Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.