Long-term Outcomes of Conduction System Pacing: a National Multicenter Observational Study - NORMAND'HIS / STIMU'HIS

Обзор

This prospective multicenter registry will evaluate the long-term electrical, echocardiographic, and clinical outcomes of conduction system pacing (CSP). There is currently limited data in the literature regarding the long-term results and benefits of CSP. The long-term maintenance of conduction system (His bundle or Left Bundle Branch) capture and physiological ventricular activation is an essential prerequisite for the expected benefits of this technique. There is currently no prospective study evaluating the preservation of CSP during long-term follow-up. The design of the present study will allow reliable evaluation of CSP maintenance at 2 years follow-up. The prospective collection of electrical data (pacing thresholds, impedance, R wave sensing) during pacemaker follow-up visits will confirm thresholds stability over the long term. The incidence of atrial fibrillation episodes will also be precisely evaluated and will provide new information. Although pathophysiological studies have demonstrated less impairment of left atrial function with conduction system pacing, there is currently no data on the incidence of atrial fibrillation in patients implanted with a CSP pacemaker. Echocardiographic data will be prospectively collected in order to analyse the evolution of left ventricular ejection fraction (LVEF) after CSP. This systematic follow-up is rarely found in CSP studies, often retrospective, with significant missing echocardiographic data. The hypothesis is that patients benefiting from CSP will not develop the deleterious effects demonstrated with conventional right ventricular pacing, such as left ventricular dilation and LVEF impairment. Inter- and intraventricular asynchrony criteria will also be systematically evaluated during follow-up echocardiography.Finally, this prospective cohort will also systematically collect clinical follow-up data (hospitalizations for heart failure and NYHA stage).

Вмешательства

• Устройство Conduction system pacing
  Conduction system pacing (His Bundle Pacing or Left Bundle Branch Area Pacing)

Первичные конечные точки

• Freedom from major adverse events [Срок оценки: 24 months]

Вторичные конечные точки (7)

• LVEF (%) [Срок оценки: 24 months]
• AF incidence [Срок оценки: 24 months]
• Heart Failure Hospitalization Incidence [Срок оценки: 24 months]
• CSP Threshold during pacemaker check (Volt @ ms) [Срок оценки: 24 months]
• Paced QRS width [Срок оценки: 24 months]
• Interventricular dyssynchrony parameters [Срок оценки: pre-discharged]
• Intraventricular dyssynchrony parameters [Срок оценки: pre-discharged]

Критерии участия

Критерии включения

• Patient who had undergone conduction system pacing attempt
• Age > 18 yo
• Capacity to understand the nature of the study, legal ability and willingness to give informed consent

Критерии исключения

• Patient under guardianship, trusteeship, or legal protection.
• Pregnant woman (positive urine pregnancy test) or breastfeeding or lack of proven effective contraception (according to the WHO definition) or menopausal without confirmed diagnosis (non-medically induced amenorrhea for at least 12 months before the inclusion visit).

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 10 центров

• CHU Caen — Caen
• CHI Elbeuf — Elbeuf
• Groupe Hospitalier La Rochelle Ré-Aunis — La Rochelle
• CH Le Havre — Le Havre
• CHU Lille — Lille
• Hôpital Saint Philibert — Lomme
• CHU Rennes — Rennes
• Rouen University Hospital — Rouen
• … и ещё 2 центра

Идентификаторы

NCT: NCT06088927 · 2020/0417/OB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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