Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2026-09-01

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.

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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.

Conditions

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Conduction System Pacing Conventional Ventricular Pacing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, unicentric, simple blind.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

The patient will be explained to be randomized to either one of the two branches. The type of therapy applied will not be communicated to the patient. The follow-up will be the same in the two branches. During the visits it will not be said which therapy has been applied.

Study Groups

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Conventional stimulation

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.

Group Type ACTIVE_COMPARATOR

Pacemaker implantation and conventional cardiac pacing

Intervention Type DEVICE

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.

Physiological stimulation

Pacing the his-purkinje system.

Group Type ACTIVE_COMPARATOR

Conduction system pacing implant

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Conduction system pacing implant

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

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No