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Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy

NCT05214365 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-03-31

No results posted yet for this study

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.

Conditions

  • Conduction System Pacing
  • Conventional Ventricular Pacing

Interventions

DEVICE

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.

DEVICE

Conduction system pacing implant

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

Sponsors & Collaborators

  • Institut d'Investigacions Biomèdiques August Pi i Sunyer

    collaborator OTHER

  • Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV)

    collaborator UNKNOWN

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Jose M Tolosana, MD, PhD · Hospital Clinic of Barcelona

  • Lluís Mont, MD, PhD · Hospital Clinic of Barcelona

  • Margarida Pujol Lopez, MD · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2026-09-01
Completion
2026-09-01
FDA Device
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05214365 on ClinicalTrials.gov