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Идёт набор NCT06561932

A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT

Без фазы С лечением Heart Failure

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: WiSE CRT System.
Кому может быть актуально
Состояния в реестре: Heart Failure. Базовые параметры: от 22 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Австралия
Следующий шаг
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Обзор

Assess the safety and efficacy of the co-implantation of the WiSE CRT System with an intracardiac pacemaker to provide totally leadless CRT.

Подробное описание

The WiSE CRT System is an implantable cardiac system to provide left ventricular (LV) pacing stimulation in conjunction with a co-implanted system that provides right ventricular (RV) stimulation. In combination, the devices deliver biventricular (BiV) pacing.

Single-arm, prospective, multicenter, observational study.

Вмешательства

  • Устройство WiSE CRT System
    The WiSE CRT System is an implantable cardiac system to provide left ventricular (LV) pacing stimulation in conjunction with a co-implanted system that provides right ventricular (RV) stimulation. In combination, the devices deliver biventricular (BiV) pacing.

Первичные конечные точки

  • Incidence of Device and procedure related complications. [Срок оценки: 1 month and 6 months]
  • Bi-Ventricular capture on 12 lead EKG [Срок оценки: 1 month and 6 months]
Вторичные конечные точки (4)
  • Change in ejection fraction (EF) from Baseline [Срок оценки: 6 months]
  • Change in in left ventricular end systolic volume (LVESV) [Срок оценки: 6 months]
  • Change in NYHA class [Срок оценки: 6 months]
  • Change in Six-minute walk test [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Patient with a class I or IIa (1) or (2) indication for implantation of a CRT device according to current available guidelines 1,2,4 (with additional QRS criteria on Class IIa (1)):
  • Class I: NYHA II, III, IV, EF ≤ 35%, LBBB, QRS ≥ 150 ms
  • Class IIa (1): NYHA II, III, IV, EF ≤ 35%, LBBB, QRS ≥ 130 to < 150 ms
  • Class IIa (2): NYHA II, III, IV, EF ≤ 35%, non-LBBB, QRS ≥ 150 ms
  • Patient or legally authorized representative can provide written authorization and/or consent per institution requirements
  • Male or Female, aged 22 years or above
  • Meets criteria for one of the two patient groups
  • Group A: De novo totally leadless CRT implant in whom the physician believes a totally leadless approach would be beneficial (e.g., wish to avoid lifelong transvenous lead implant, anatomical constraints, history of device infection).
  • Patients with symptomatic AF and an uncontrolled heart rate who are candidates for AV node ablation (irrespective of QRS duration and LVEF), and in whom the physician believes a leadless pacing approach would be beneficial.
  • Patients with high degree AV block who have an indication for permanent pacing (with a LVEF ≤ 50%), are expected to require ventricular pacing more than 40% of the time, and in whom the physician believes a leadless approach would be beneficial.
  • Group B: Upgrade chronic intracardiac pacemaker to CRT
  • Patients with existing intracardiac pacemakers with greater than 20% RV pacing, who have developed symptomatic HF.

Критерии исключения

  • Patient who is or is expected to be inaccessible for follow-up visits
  • Female participant who is pregnant, lactating, or planning pregnancy during the course of the study
  • Inability to comply with the study follow-up or other study requirements
  • History of chronic alcohol/ drug abuse and currently using alcohol/ drugs
  • Non-ambulatory (or unstable) NYHA class 4
  • Life expectancy less than 12 months
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
  • Patient who is enrolled in another clinical study that could confound the results of this study (Note: patients enrolled in complementary study are eligible for enrolment)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Австралия · 4 центра
  • Patients of Sunshine Coast University Hospital — Birtinya
  • Royal Brisbane and Women's Hospital — Herston
  • Patients of Gold Coast University Hospital — Southport
  • Princess Alexandra Hospital — Woolloongabba

Идентификаторы

NCT: NCT06561932 · CSP-10002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗