Heart FailureDA VINCINCT07107048
Clinical Prospective ranDomized Trial to Evaluate the Non-inferiority of Left Bundle Branch Area Pacing Vs Cardiac ResynchronIzatioN Therapy With ECG guIded AV Optimization
A study testing Pacemaker and defibrillator in people with Heart Failure, run by Leonardo Calò, MD at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Pacemaker and defibrillator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteItaly
- Study dates
- 30 Oct 2025to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- • 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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)
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.
Read more
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Pacemaker and defibrillator
- Keywords
- lbbap, crt
- Medical subject headings
- Heart Failure, Creatine deficiency, X-linked
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker and defibrillatorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| LBBAP | Experimental | Patients undergoing left bundle branch area pacing (LBBAP) implantation Receives: Device: Pacemaker and defibrillator |
| CRT Biv | Active comparator | Patients undergoing cardiac resynchronization therapy (CRT) with biventricular pacing Receives: Device: Pacemaker and defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start30 Oct 2025 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leonardo Calò, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National association Cardiovascular innovation
- Responsible party
- Sponsor-investigator, Leonardo Calò, MD, Policlinico Casilino ASL RMB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107048
- Sponsor's protocol ID
- v1 7jul25
- Acronym
- DA VINCI
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07107048
- Acronym / sponsor ID
- DA VINCI / v1 7jul25
- Conditions
- Heart Failure
- Keywords
- lbbap, crt
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Leonardo Calò, MDUniversity, hospital or other
- Collaborators
- National association Cardiovascular innovation
- Study start
- 30 Oct 2025 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LBBAP | Experimental | Device: Pacemaker and defibrillatorPatients undergoing left bundle branch area pacing (LBBAP) implantation |
| CRT Biv | Active comparator | Device: Pacemaker and defibrillatorPatients undergoing cardiac resynchronization therapy (CRT) with biventricular pacing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- • Women who are pregnant, lactating, or plan to become pregnant during the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacemaker and defibrillatorPatients will be randomly assigned at enrollment (1:1) to undergo either LBBAP or CRT with biventricular stimulation. The devices implanted maybe defibrillators or pacemekers. | Device | CRT Biv, LBBAP |
Primary outcome
CRT response
Time frame: 6 months
CRT RESPONSE WILL BE DEFINED: * Freedom from HF Hospitalizations * Freedom from Cardiac Death * Reverse remodeling: ≥15% relative reduction in left ventricular end-systolic volume
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacemaker and defibrillator in people with Heart Failure, run by Leonardo Calò, MD at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leonardo Calò, MD (06231881, leonardocalo.doc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRT response (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.