LBBP + CSP Versus LBBP Alone for Cardiac Resynchronization Therapy

Left Bundle Branch Pacing + Coronary Sinus Pacing Versus Left Bundle Branch Pacing Alone for Cardiac Resynchronization Therapy in Patients Eligible for CRT-P A Randomized Crossover Pilot Clinical Trial

The purpose of this pilot clinical trial is to evaluate whether a novel cardiac resynchronization strategy, called LOT-CRT, is more effective than standard physiological pacing alone (LBBAP) in patients with heart failure.

This is a randomized, single-center, crossover pilot study involving 10 patients. All participants will receive a specialized pacemaker (CRT-P) with leads implanted in two specific areas: the Left Bundle Branch Area (LBBAP) and the Coronary Sinus (CS).

Because of the crossover design, each patient will serve as their own control, receiving two different pacing configurations in a random order: Active Phase (LOT-CRT): Simultaneous pacing of the left bundle branch and the coronary sinus. Control Phase (LBBAP alone): Pacing only the left bundle branch area. Each treatment phase will last 6 months, for a total follow-up of 12 months per patient.

By testing both strategies in the same patient, this study will help clinicians identify the most effective way to restore heart synchrony and improve clinical outcomes in patients with advanced heart failure and conduction delays.

This is a single-center, randomized, crossover pilot clinical trial. Each patient will serve as their own control. Following the successful implantation of a device capable of stimulating the LBBAP and the coronary sinus, participants will be randomly assigned to one of two treatment sequences:

Sequence A: LOT-CRT (LBBAP + CS) for 6 months, followed by LBBAP alone Sequence B: LBBAP alone for 6 months, followed by LOT-CRT Each treatment phase will last 6 months, followed by an end-point evaluation and a crossover. Since the hemodynamic effect of electrical stimulation is immediate, no washout period is required between phases.

This study was designed as an exploratory pilot study; therefore, no formal sample size calculation was performed. The number of patients enrolled is considered adequate to assess the feasibility of the procedure, the safety of the crossover design, and to identify preliminary signals of clinical and electrical efficacy.

Inclusion Criteria:

1. Age ≥18 years
2. Standard CRT-P indications according to ESC 2021 (EF ≤50%, QRS ≥130 ms, sinus rhythm or controlled AF)
3. NYHA class II-IV
4. Coronary venous anatomy suitable for placement of a coronary sinus electrode.
5. Signed informed consent.
6. Successful implantation of electrodes in the coronary sinus and in the left bundle branch area (LBBAP)

Exclusion Criteria:

1. Concomitant indication for implantation of an implantable cardioverter-defibrillator (ICD) or CRT-D
2. Significant uncorrected valvular disease or scheduled or anticipated cardiac surgery during the study period.
3. Anatomical or technical contraindication for lead implantation in the coronary sinus or for lead implantation in the coronary sinus (such as sinus stenosis, coronary sinus branches unsuitable for cannulation, inability to advance and/or stabilize the lead, among others)
4. Persistent atrial fibrillation with uncontrolled rate
5. Comorbidities that may limit life expectancy to <1 year
6. Participation in another clinical trial that could confound the evaluation of results within the last 6 months.
7. Pregnancy or inadequate contraception
8. In the researcher's opinion, the participant would not comply with the activities and visits outlined in the study protocol