Minimally Invasive Hemodynamic Monitoring in Cardiac Ablation
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: Minimally invasive hemodynamic monitoring.
- Кому может быть актуально
- Состояния в реестре: Cardiac Arrythmias, Anesthesia. 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
- Turkey (Türkiye)
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Prospective Clinical Study of Minimally Invasive Hemodynamic Monitoring Outcomes in Cardiac Ablation Procedures
Обзор
This prospective observational clinical study aims to evaluate the clinical utility of Pressure Recording Analytical Method (PRAM)-based minimally invasive hemodynamic monitoring in patients undergoing cardiac ablation procedures. The study will be conducted in the cardiac catheterization laboratory of Istanbul University-Cerrahpaşa Cardiology Institute and will include 27 adult patients scheduled for catheter ablation. Written informed consent will be obtained from all participants, and the study will adhere to the principles of the Declaration of Helsinki.
Подробное описание
Cardiac ablation procedures performed in electrophysiology laboratories are increasingly complex and frequently conducted under non-operating room anesthesia (NORA). These procedures carry a risk of hemodynamic instability due to arrhythmia induction, procedural manipulation, and potential complications such as cardiac tamponade, thromboembolism, or fluid overload. Continuous and accurate hemodynamic monitoring is therefore essential for optimal patient management. However, data on the use of minimally invasive hemodynamic monitoring techniques in this setting remain limited.
This prospective observational clinical study aims to evaluate the clinical utility of Pressure Recording Analytical Method (PRAM)-based minimally invasive hemodynamic monitoring in patients undergoing cardiac ablation procedures. The study will be conducted in the cardiac catheterization laboratory of Istanbul University-Cerrahpaşa Cardiology Institute and will include 27 adult patients scheduled for catheter ablation. Written informed consent will be obtained from all participants, and the study will adhere to the principles of the Declaration of Helsinki.
All patients will undergo standard monitoring, including electrocardiography, heart rate, pulse oximetry, and invasive arterial blood pressure measurement via radial or femoral arterial access. In addition, continuous beat-to-beat hemodynamic data will be obtained using the MostCare® system, which applies the PRAM algorithm for real-time waveform analysis.
Primary hemodynamic parameters include heart rate, systolic, diastolic, and mean arterial pressures. Advanced parameters such as stroke volume, cardiac output, cardiac index, systemic vascular resistance, stroke volume variation, pulse pressure variation, dP/dt max, and cardiac cycle efficiency will also be recorded. Measurements will be collected at three predefined time points: before ablation (T0), during ablation (T1), and after ablation (T2).
The primary objective is to assess time-dependent changes in hemodynamic parameters and evaluate the contribution of PRAM-based monitoring to intra-procedural patient management. Secondary aims include generating evidence to support anesthesiologists' clinical decision-making and contributing to the development of future guidelines for high-risk NORA settings.
Statistical analysis will be performed using repeated measures methods, with a significance level set at p\<0.05.
Вмешательства
- Другое Minimally invasive hemodynamic monitoring
Continuous beat-to-beat hemodynamic monitoring using the Pressure Recording Analytical Method (PRAM) via an invasive arterial line.
Первичные конечные точки
- Change in Cardiac Output measured by PRAM during catheter ablation [Срок оценки: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)]
Вторичные конечные точки (8)
- Change in Cardiac Index During Catheter Ablation [Срок оценки: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)]
- Change in Stroke Volume During Catheter Ablation [Срок оценки: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)]
- Change in Mean Arterial Pressure During Catheter Ablation [Срок оценки: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)]
- Change in Systemic Vascular Resistance During Catheter Ablation [Срок оценки: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)]
- Change in Stroke Volume Variation During Catheter Ablation [Срок оценки: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)]
- Change in Pulse Pressure Variation During Catheter Ablation [Срок оценки: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)]
- Change in dP/dt max During Catheter Ablation [Срок оценки: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)]
- Change in Cardiac Cycle Efficiency During Catheter Ablation [Срок оценки: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)]
Критерии участия
Критерии включения
- Age ≥18 years
- Patients scheduled for cardiac catheter ablation in the electrophysiology laboratory
- Indication for ablation confirmed by a cardiologist
- Ability to provide written informed consent
- Planned invasive arterial blood pressure monitoring during the procedure
Критерии исключения
- Refusal or inability to provide informed consent
- Failure to identify arrhythmogenic focus leading to cancellation of ablation procedure
- Severe hemodynamic instability prior to procedure
- Contraindication to invasive arterial catheterization
- Incomplete hemodynamic data acquisition
- Pregnancy
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Turkey (Türkiye) · 1 центр
- Istanbul University-Cerrahpasa, Institute of Cardiology — Istanbul
Идентификаторы
NCT: NCT07603765 · 018