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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

NCT07107048 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2025-08-06

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • National association Cardiovascular innovation

    collaborator UNKNOWN

  • Leonardo Calò, MD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-30
Primary Completion
2027-04-30
Completion
2027-10-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07107048 on ClinicalTrials.gov