Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy

NCT05214365 | Recruiting FDA Device

• 1 other identifier: PHYSPAVB
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Conventional Ventricular Pacing; Conduction System Pacing

Keywords

Pacemaker-induced cardiomyopathy

Outcome Measures

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.

  12 months

Secondary Outcomes (11)

• Change in end-systolic volume.

  12 Months

• Correction of septal flash.

  12 Months

• Incidence of new onset of atrial fibrillation.

  12 Months

• Hospitalization due to heart failure.

  12 Months

• New York Heart Association functional classification.

  12 Months

Study Arms (2)

Conventional stimulation

ACTIVE COMPARATOR

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.

Device: Pacemaker implantation and conventional cardiac pacing

Physiological stimulation

ACTIVE COMPARATOR

Pacing the his-purkinje system.

Device: Conduction system pacing implant

Interventions

Conduction system pacing implant DEVICE

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

Physiological stimulation

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.

Conventional stimulation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV): collaborator
• Hospital Clinic of Barcelona: lead
• Institut d'Investigacions Biomèdiques August Pi i Sunyer: collaborator

Study Sites (1)

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

RECRUITING

Study Officials

• Jose M Tolosana, MD, PhD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

• Lluís Mont, MD, PhD

  Hospital Clinic of Barcelona

  STUDY DIRECTOR

• Margarida Pujol Lopez, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lluís Mont, MD, PhD

CONTACT

+34 93 2271778; lmont@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Arrhythmia Section. Professor of Cardiology

Model Details: Randomized, unicentric, simple blind.

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: January 28, 2022
• Study Start: February 1, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)