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LBBP + CSP Versus LBBP Alone for Cardiac Resynchronization Therapy

NCT07664189 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-07-23

No results posted yet for this study

Summary

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.

Conditions

  • Heart Failure Low Output

Interventions

DEVICE

Left Bundle Branch Optimized CRT

The CS lead will be implanted in a posterolateral or lateral vein using venography and standard IV delivery sheaths. Proper lead placement is confirmed by stable fixation, pacing capture, and absence of diaphragmatic pacing. The configuration for each phase of the study (LOT-CRT or LBBAP alone) will be assigned during randomization.

DEVICE

Stimulation of the left bundle branch area (LBBAP)

The LBBAP lead will be implanted via a transvenous approach using the C315His sheath, targeting the left bundle branch area in the right ventricular septum, ideally between the basal septum and the mid-septal region. Criteria for confirming successful LBBAP capture will include: * Evidence of narrowing of the stimulated QRS complex compared to baseline. * Right bundle branch block morphology on the ECG-stimulus-to-R-wave time in V6 \<80 ms (if available). * Low and stable pacing threshold (\<1.5 V @ 0.4 ms). * Unipolar impedance between 400-1500 ohms. The CS lead will be implanted in a posterolateral or lateral vein using venography and standard IV delivery sheaths. Proper lead placement is confirmed by stable fixation, pacing capture, and absence of diaphragmatic pacing.

Sponsors & Collaborators

  • Clinica Cardio VID

    lead OTHER

Principal Investigators

  • Juan F Agudelo, Electrophysiologist · Clinica CardioVID

  • Susana Rios, Medical Epidemiologist · Clinica CardioVID

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-09
Primary Completion
2027-07-01
Completion
2027-12-01
FDA Device
Yes

Countries

  • Colombia

Study Locations

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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 NCT07664189 on ClinicalTrials.gov