NCT05214365

Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy

Physiological Pacing vs.Conventional Pacing in the Prevention of Pacemaker-induced Cardiomyopathy: A Randomized Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The implantation of a pacemaker and conventional cardiac pacing from the right ventricle (apex or septum) is an effective and safe therapy for the treatment of patients with atrioventricular block and bradycardia.

Detailed description

Pacemaker implantation and conventional cardiac stimulation from the right ventricle is an effective and safe therapy for the treatment of patients with atrioventricular block and bradycardia. But it can cause worsening of heart function, with a significant drop in LV ejection fraction, known as pacemaker-induced cardiomyopathy (PICM). Conduction system pacing (either by his or left bundle branch pacing) causes a physiological left ventricular activation through the normal conduction system thus correcting the electrical and mechanical asynchrony caused by conventional pacing. Conduction system pacing may prevent the appareance of PICM. Clinical, electrocardiographic, echocardiographic follow-up will be performed for 1 year.

Conditions

• Conduction System Pacing
• Conventional Ventricular Pacing

Interventions

Type	Name	Description
DEVICE	Pacemaker implantation and conventional cardiac pacing	Patients will have the pacemaker implanted in the electrophysiology laboratory. Electrode will be implanted (in the apical or septal portion) according to the criteria of the implanting physician.
DEVICE	Conduction system pacing implant	Right ventricular lead was placed to get his bundle or left bundle branch.

Timeline

• Start date: 2022-02-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2022-01-28
• Last updated: 2026-03-31

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated device study