Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Compare the incidence of pacemaker-induced heart disease [Срок оценки: 12 months]

Вторичные конечные точки (11)

• Change in end-systolic volume. [Срок оценки: 12 Months]
• Correction of septal flash. [Срок оценки: 12 Months]
• Incidence of new onset of atrial fibrillation. [Срок оценки: 12 Months]
• Hospitalization due to heart failure. [Срок оценки: 12 Months]
• New York Heart Association functional classification. [Срок оценки: 12 Months]
• Pacing thresholds. [Срок оценки: 12 Months]
• Total implantation and electrode implantation times. [Срок оценки: 12 Months]
• Adverse events. [Срок оценки: 12 Months]
• Six minute walking test. [Срок оценки: 12 Months]
• The Quality of Life Scale. [Срок оценки: 12 Months]
• NT-proBNP. [Срок оценки: 12 Months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Clinic of Barcelona — Barcelona

Идентификаторы

NCT: NCT05214365 · PHYSPAVB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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