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

Hospital Clinic of Barcelona

Status: Enrolling

Conditions: Conventional Ventricular Pacing; Conduction System Pacing

Treatments: Device: Pacemaker implantation and conventional cardiac pacing; Device: Conduction system pacing implant

Study type: Interventional

Funder types: Other

Identifiers

NCT05214365

PHYSPAVB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

200 participants in 2 patient groups

Conventional stimulation

Active Comparator group

Description:

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.

Treatment:

Device: Pacemaker implantation and conventional cardiac pacing

Physiological stimulation

Active Comparator group

Description:

Pacing the his-purkinje system.

Treatment:

Device: Conduction system pacing implant