Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Conduction System Pacing, Conventional Ventricular Pacing

Intervention / Treatment
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* Device: Pacemaker implantation and conventional cardiac pacing
* Device: Conduction system pacing implant


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, unicentric, simple blind.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional stimulation<br>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. | Device: Pacemaker implantation and conventional cardiac pacing<br>* 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.<br>|
| Active Comparator: Physiological stimulation<br>Pacing the his-purkinje system. | Device: Conduction system pacing implant<br>* Right ventricular lead was placed to get his bundle or left bundle branch.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the incidence of pacemaker-induced heart disease | Pacemaker induced cardiomyopathy defined as appearance of ventricular dysfunction LVEF <45% or admission due to heart failure. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in end-systolic volume. | VTSVI | 12 Months | 
| Correction of septal flash. | Correction of septal flash determined with echocardiography (M mode) | 12 Months | 
| Incidence of new onset of atrial fibrillation. |  | 12 Months | 
| Hospitalization due to heart failure. | Hospitalization: patient hospitalization (yes/no) | 12 Months | 
| New York Heart Association functional classification. | 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. | 12 Months | 
| Pacing thresholds. | Pacing thresholds. | 12 Months | 
| Total implantation and electrode implantation times. | Total implantation and electrode implantation times. | 12 Months | 
| Adverse events. | Resulted in reintervention or the termination of significant device function | 12 Months | 
| Six minute walking test. | Six minute walking test. | 12 Months | 
| The Quality of Life Scale. | 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). | 12 Months | 
| NT-proBNP. | NT-proBNP measure | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pacemaker-induced cardiomyopathy