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Recruiting NCT05214365

Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy

No phase Interventional Conduction System Pacing Conventional Ventricular Pacing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pacemaker implantation and conventional cardiac pacing, Conduction system pacing implant.
Who it may be relevant to
Registry conditions: Conduction System Pacing, Conventional Ventricular Pacing. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

Detailed description

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.

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.

Primary outcome measures

  • Compare the incidence of pacemaker-induced heart disease [Time frame: 12 months]
Secondary outcome measures (11)
  • Change in end-systolic volume. [Time frame: 12 Months]
  • Correction of septal flash. [Time frame: 12 Months]
  • Incidence of new onset of atrial fibrillation. [Time frame: 12 Months]
  • Hospitalization due to heart failure. [Time frame: 12 Months]
  • New York Heart Association functional classification. [Time frame: 12 Months]
  • Pacing thresholds. [Time frame: 12 Months]
  • Total implantation and electrode implantation times. [Time frame: 12 Months]
  • Adverse events. [Time frame: 12 Months]
  • Six minute walking test. [Time frame: 12 Months]
  • The Quality of Life Scale. [Time frame: 12 Months]
  • NT-proBNP. [Time frame: 12 Months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Hospital Clinic of Barcelona — Barcelona

Identifiers

NCT: NCT05214365 · PHYSPAVB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗