Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy

Hospital Clinic of Barcelona200 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

200

Conditions

Conduction System Pacing Conventional Ventricular Pacing

Interventions

Pacemaker implantation and conventional cardiac pacingDEVICE

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.

Conduction system pacing implantDEVICE

Right ventricular lead was placed to get his bundle or left bundle branch.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Clinic of Barcelona

Barcelona, Spain

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

Change in end-systolic volume.

VTSVI

Time frame: 12 Months

Correction of septal flash.

Correction of septal flash determined with echocardiography (M mode)

Time frame: 12 Months

Incidence of new onset of atrial fibrillation.

Time frame: 12 Months

Hospitalization due to heart failure.

Hospitalization: patient hospitalization (yes/no)

Time frame: 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.

Time frame: 12 Months

Pacing thresholds.

Time frame: 12 Months

Total implantation and electrode implantation times.

Central Contacts

Lluís Mont, MD, PhD

CONTACT

+34 93 2271778 lmont@clinic.cat

Data from ClinicalTrials.gov

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