Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy (PHYSPAVB)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Conduction System Pacing; Conventional Ventricular Pacing
• Intervention / Treatment: Device: Pacemaker implantation and conventional cardiac pacing; Device: Conduction system pacing implant

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lluís Mont, MD, PhD; Phone Number: +34 93 2271778; Email: lmont@clinic.cat

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic of Barcelona
    • Contact: Lluís Mont, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional stimulation; 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; 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.
Active Comparator: Physiological stimulation; Pacing the his-purkinje system.	Device: Conduction system pacing implant; Right ventricular lead was placed to get his bundle or left bundle branch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in end-systolic volume.	VTSVI	12 Months
Correction of septal flash.	Correction of septal flash determined with echocardiography (M mode)	12 Months
Incidence of new onset of atrial fibrillation.		12 Months
Hospitalization due to heart failure.	Hospitalization: patient hospitalization (yes/no)	12 Months
New York Heart Association functional classification.	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.	12 Months
Pacing thresholds.	Pacing thresholds.	12 Months
Total implantation and electrode implantation times.	Total implantation and electrode implantation times.	12 Months
Adverse events.	Resulted in reintervention or the termination of significant device function	12 Months
Six minute walking test.	Six minute walking test.	12 Months
The Quality of Life Scale.	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).	12 Months
NT-proBNP.	NT-proBNP measure	12 Months

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Collaborators: Institut d'Investigacions Biomèdiques August Pi i Sunyer; Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV)
• Investigators: Study Director: Lluís Mont, MD, PhD, Hospital Clinic of Barcelona; Principal Investigator: Jose M Tolosana, MD, PhD, Hospital Clinic of Barcelona; Principal Investigator: Margarida Pujol Lopez, MD, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 17, 2022
• First Submitted That Met QC Criteria: January 17, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 9, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Pacemaker-induced cardiomyopathy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: PHYSPAVB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes