NCT07664189Enrolling by invitation
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
Source: ClinicalTrials.gov · Last updated 23 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 26 May 2026
- Start date
- 9 Jun 2026
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- Clinica Cardio VID
- Diseases
- Heart failure
- NCT number
- NCT07664189
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 9 Jun 2026 to the primary completion date, 1 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant indication for implantation of an implantable cardioverter-defibrillator (ICD) or CRT-D
Other illness
- Significant uncorrected valvular disease or scheduled or anticipated cardiac surgery during the study period.
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinica CardioVID Coordinator of this site? Confirm its status | Medellín | Colombia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.