Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy

Not Applicable

Recruiting

• Conditions: Conduction System Pacing; Conventional Ventricular Pacing
• Interventions: Device: Pacemaker implantation and conventional cardiac pacing; Device: Conduction system pacing implant

• Registration Number: NCT05214365
• Lead Sponsor: Hospital Clinic of Barcelona

Brief 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.

Study Timeline

• Study First Submitted: 2022-01-17
• Study First Submitted QC: 2022-01-17
• Study First Posted: 2022-01-28
• Study Start: 2022-02-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-18
• Primary Completion: 2025-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• The patient must be ≥ 18 years of age.
• The patient must indicate their acceptance to participate in the study by signing an informed consent document.
• Patients with EF> 50% and indication for pacemaker implantation due to atrial-ventricular block according to current clinical guidelines.

Exclusion Criteria

• Inability to understand and sign the informed consent.
• Patients with severe comorbidities and life expectancy <1 year.
• Patients with severe cognitive impairment or other comorbidities resulting in dependence for basic activities of daily life.
• Patients who cannot come to our center to carry out the follow-up of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional stimulation	Pacemaker implantation and conventional cardiac pacing	An electrode (in the apical or septal portion) will be implanted at the discretion of the implanter physician. Parameters of (sensing, impedance and threshold) will be measured as is usually done in our center.
Physiological stimulation	Conduction system pacing implant	Pacing the his-purkinje system.

Primary Outcome Measures

Name	Time	Method
Compare the incidence of pacemaker-induced heart disease	12 months	Pacemaker induced cardiomyopathy defined as appearance of ventricular dysfunction LVEF \<45% or admission due to heart failure.

Secondary Outcome Measures

Name	Time	Method
Correction of septal flash.	12 Months	Correction of septal flash determined with echocardiography (M mode)
Total implantation and electrode implantation times.	12 Months	Total implantation and electrode implantation times.
Change in end-systolic volume.	12 Months	VTSVI
The Quality of Life Scale.	12 Months	The Minnesota living with heart failure questionnaire. The most widely used health-related quality of life questionnaires for patients with heart failure. Values from 0 to 105 (more is worse).
NT-proBNP.	12 Months	NT-proBNP measure
Incidence of new onset of atrial fibrillation.	12 Months
Adverse events.	12 Months	Resulted in reintervention or the termination of significant device function
Hospitalization due to heart failure.	12 Months	Hospitalization: patient hospitalization (yes/no)
New York Heart Association functional classification.	12 Months	Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.; Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest.; Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
Pacing thresholds.	12 Months	Pacing thresholds.
Six minute walking test.	12 Months	Six minute walking test.

Trial Locations

Locations (1)

Hospital Clinic of Barcelona; 🇪🇸 Barcelona, Spain