Health TrialsbyHealthPanel

Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy

ConditionsConduction System PacingConventional Ventricular Pacing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorHospital Clinic of Barcelona

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pacemaker implantation and conventional cardiac pacing

    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.

  • Conduction system pacing implant

    Device

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Conventional stimulationActive comparator 1 intervention
Group B: Physiological stimulationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

Change in end-systolic volume.

VTSVI

Time frame
12 Months
2

Correction of septal flash.

Correction of septal flash determined with echocardiography (M mode)

Time frame
12 Months
3

Incidence of new onset of atrial fibrillation.

Time frame
12 Months
4

Hospitalization due to heart failure.

Hospitalization: patient hospitalization (yes/no)

Time frame
12 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Clinic of Barcelona

Lead sponsor

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Collaborator

Consorcio Centro de Investigación Biomédica en Red (CIBER)

Collaborator

Source ClinicalTrials.gov
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