Clinical trial NCT05214365: Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy
Official title: Physiological Pacing vs.Conventional Pacing in the Prevention of Pacemaker-induced Cardiomyopathy: A Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Conduction System Pacing
Conventional Ventricular Pacing
Keywords: Pacemaker-induced cardiomyopathy
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Institut d'Investigacions Biomèdiques August Pi i Sunyer
name: Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV)
First posted: 2022-01-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, unicentric, simple blind.
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Compare the incidence of pacemaker-induced heart disease
timeFrame: 12 months
Secondary outcomes:
measure: Change in end-systolic volume.
timeFrame: 12 Months
measure: Correction of septal flash.
timeFrame: 12 Months
measure: Incidence of new onset of atrial fibrillation.
timeFrame: 12 Months
measure: Hospitalization due to heart failure.
timeFrame: 12 Months
measure: New York Heart Association functional classification.
timeFrame: 12 Months
measure: Pacing thresholds.
timeFrame: 12 Months
measure: Total implantation and electrode implantation times.
timeFrame: 12 Months
measure: Adverse events.
timeFrame: 12 Months
measure: Six minute walking test.
timeFrame: 12 Months
measure: The Quality of Life Scale.
timeFrame: 12 Months
measure: NT-proBNP.
timeFrame: 12 Months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Jose M Tolosana, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic of Barcelona
name: Lluís Mont, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Clinic of Barcelona
name: Margarida Pujol Lopez, MD
role: PRINCIPAL_INVESTIGATOR
References: