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Two pacing methods compared in people with heart failure and a pacemaker

Compares two ways of pacing the heart in adults with heart failure.

Plain-language title generated from the registry record
Registry title: LBBP + CSP Versus LBBP Alone for Cardiac Resynchronization Therapy

Key facts

Where
Medellín, ColombiaSee the site

Where in Colombia

  • Clinica CardioVIDMedellín, ColombiaNo longer taking part

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  4. What happens if I want to stop?
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Trial details

Who runs it
Clinica Cardio VID
Trial code
NCT07664189
Record updated
23 July 2026
Original description
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.Read full original descriptionShow less

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.

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

Exclusion: Concomitant indication for implantation of an implantable cardioverter-defibrillator (ICD) or CRT-D; Significant uncorrected valvular disease or scheduled or anticipated cardiac surgery during the study period; 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); Persistent atrial fibrillation with uncontrolled rate; Comorbidities that may limit life expectancy to <1 year; Participation in another clinical trial that could confound the evaluation of results within the last 6 months; Pregnancy or inadequate contraception; In the researcher's opinion, the participant would not comply with the activities and visits outlined in the study protocol.

ClinicalTrials.gov NCT07664189