Real-World Data on the Effects of Cardiac Resynchronization Therapy in Adult Patients With Congenital Heart Disease
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: Cardiac resynchronization therapy.
- Кому может быть актуально
- Состояния в реестре: Adult Congenital Heart Disease. Базовые параметры: от 18 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
- Нидерланды
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This study aims to evaluate the real-world effects of cardiac resynchronization therapy (CRT) in adult patients with congenital heart disease (ACHD). Specifically, it seeks to determine whether CRT improves clinical outcomes in this unique patient population and to identify factors associated with a favorable response to therapy.
Подробное описание
Cardiac resynchronization therapy (CRT) is well-established in acquired heart failure, but evidence in ACHD remains limited. Current guidelines, extrapolated from non-congenital populations, may not fully address the anatomical and electrophysiological complexities in ACHD.
This retrospective cohort study aims to investigate the real-world efficacy and safety of CRT in adult patients with congenital heart disease (ACHD). The study includes consecutive ACHD patients who underwent either de novo CRT implantation or upgrade procedures, starting from January 2014.
The primary objectives are to evaluate changes in QRS duration, systemic ventricular function, and New York Heart Association (NYHA) functional class. The study aims to further examine the impact of CRT in specific ACHD subgroups, including patients with systemic right ventricles (vs. systemic left ventricles), those with non-left bundle branch block (non-LBBB) morphology (vs. LBBB), and those with upgrade procedures (vs. de novo implants).
Data collection is based on retrospective review of electronic health records, including patient demographics, clinical characteristics, device-related procedural details, and follow-up data. Outcomes are assessed using standardized echocardiographic and electrocardiographic measurements, alongside clinical evaluations.
The study aims to provide comprehensive real-world insights into the efficacy and safety of CRT in the diverse ACHD population and to identify predictors of favorable response, ultimately supporting more individualized decision-making in this complex patient group.
Вмешательства
- Устройство Cardiac resynchronization therapy
Cardiac resynchronization therapy pacemaker or defibrillator with a transvenous or epicardial systemic ventricle lead
Первичные конечные точки
- QRS duration [Срок оценки: From enrollment through study completion, with an average follow-up duration of 1 year.]
- Systemic ventricle function class [Срок оценки: From enrollment through study completion, with an average follow-up duration of 1 year.]
- NYHA functional class [Срок оценки: From enrollment through study completion, with an average follow-up duration of 1 year.]
Вторичные конечные точки (12)
- Clinical - Mortality [Срок оценки: From enrollment through study completion, with an average follow-up duration of 1 year.]
- Clinical - Heart failure hospitalization [Срок оценки: From enrollment through study completion, with an average follow-up duration of 1 year.]
- Clinical - CV hospitalization other than HF [Срок оценки: From enrollment through study completion, with an average follow-up duration of 1 year.]
- Clinical - Urgent heart failure visit [Срок оценки: From enrollment through study completion, with an average follow-up duration of 1 year.]
- Clinical - Urgent CV visit other than HF [Срок оценки: From enrollment through study completion, with an average follow-up duration of 1 year.]
- Clinical - Enlisting for LVAD [Срок оценки: From enrollment through study completion, with an average follow-up duration of 1 year.]
- Clinical - Enlisting for HTX [Срок оценки: One year after implantation]
- Clinical - Periprocedurel complications [Срок оценки: From enrollment through study completion, with an average follow-up duration of 1 year.]
- CIED-related - Threshold systemic ventricular lead [Срок оценки: From enrollment through study completion, with an average follow-up duration of 1 year.]
- CIED-related - Impedance systemic ventricular lead [Срок оценки: From enrollment through study completion, with an average follow-up duration of 1 year.]
- CIED-related - R-wave sensing systemic ventricular lead [Срок оценки: From enrollment through study completion, with an average follow-up duration of 1 year.]
- CIED-related - ICD therapy [Срок оценки: From enrollment through study completion, with an average follow-up duration of 1 year.]
Критерии участия
Критерии включения
- ACHD patients who underwent CRT implantation
Критерии исключения
- Less than 18 years old on the moment of CRT implantation
- Patient objection to the use of retrospective data
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Нидерланды · 1 центр
- Leiden University Medical Center (LUMC) — Leiden
Идентификаторы
NCT: NCT06969924 · 2023-035