LBBP + CSP Versus LBBP Alone for Cardiac Resynchronization Therapy
Enrolling by invitation · Not applicable
Conditions studied: Heart Failure Low Output
In brief
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.
Key facts
- Study ID
- NCT07664189
- Run by
- Clinica Cardio VID
- People needed
- 10
- Starts
- 2026-06-09
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-07-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Clinica CardioVID — Medellín, Antioquia, Colombia
Full record on ClinicalTrials.gov
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