Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05214365

Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Conduction System Pacing Conventional Ventricular Pacing

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

Location status: Recruiting

Location contact

Lluís Mont, MD PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Compare the incidence of pacemaker-induced heart disease

    Time frame: 12 months

    Pacemaker induced cardiomyopathy defined as appearance of ventricular dysfunction LVEF <45% or admission due to heart failure.

Secondary outcomes

  1. Change in end-systolic volume.

    Time frame: 12 Months

    VTSVI

  2. Correction of septal flash.

    Time frame: 12 Months

    Correction of septal flash determined with echocardiography (M mode)

  3. Incidence of new onset of atrial fibrillation.

    Time frame: 12 Months

  4. Hospitalization due to heart failure.

    Time frame: 12 Months

    Hospitalization: patient hospitalization (yes/no)

  5. New York Heart Association functional classification.

    Time frame: 12 Months

    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.

  6. Pacing thresholds.

    Time frame: 12 Months

    Pacing thresholds.

  7. Total implantation and electrode implantation times.

    Time frame: 12 Months

    Total implantation and electrode implantation times.

  8. Adverse events.

    Time frame: 12 Months

    Resulted in reintervention or the termination of significant device function

  9. Six minute walking test.

    Time frame: 12 Months

    Six minute walking test.

  10. The Quality of Life Scale.

    Time frame: 12 Months

    The Minnesota living with heart failure questionnaire. The most widely used health-related quality of life questionnaires for patients with heart failure. Values from 0 to 105 (more is worse).

  11. NT-proBNP.

    Time frame: 12 Months

    NT-proBNP measure

Study contacts

Contact information is provided by the study sponsor or research team.

Lluís Mont, MD, PhD

CONTACT

[email protected]

+34 93 2271778

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Consorcio Centro de Investigación Biomédica en Red (CIBER)
  • Institut d'Investigacions Biomèdiques August Pi i Sunyer

Registry information

Official study title

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

Acronym: PHYSPAVB

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2022
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.