Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy

Conduction System Pacing Clinical Trial

— PHYSPAVB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05214365
• Other study ID #: PHYSPAVB
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: December 2023
• Source: Hospital Clinic of Barcelona
• Contact: Lluís Mont, MD, PhD
• Phone: +34 93 2271778
• Email: lmont[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Conduction System Pacing

Intervention

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.
• Conduction system pacing implant
Right ventricular lead was placed to get his bundle or left bundle branch.

Locations

Country	Name	City	State
Spain	Hospital Clinic of Barcelona	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV), Institut d'Investigacions Biomèdiques August Pi i Sunyer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in end-systolic volume.	VTSVI	12 Months
Secondary	Correction of septal flash.	Correction of septal flash determined with echocardiography (M mode)	12 Months
Secondary	Incidence of new onset of atrial fibrillation.		12 Months
Secondary	Hospitalization due to heart failure.	Hospitalization: patient hospitalization (yes/no)	12 Months
Secondary	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
Secondary	Pacing thresholds.	Pacing thresholds.	12 Months
Secondary	Total implantation and electrode implantation times.	Total implantation and electrode implantation times.	12 Months
Secondary	Adverse events.	Resulted in reintervention or the termination of significant device function	12 Months
Secondary	Six minute walking test.	Six minute walking test.	12 Months
Secondary	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
Secondary	NT-proBNP.	NT-proBNP measure	12 Months