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临床试验/NCT07603765
NCT07603765已完成不适用

Prospective Clinical Study of Minimally Invasive Hemodynamic Monitoring Outcomes in Cardiac Ablation Procedures

Istanbul University - Cerrahpasa2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2026年4月30日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
27
试验地点
2

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

未指定

次要结局

  • Change in Arterial Elastance(Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation))

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gozde Altun

lecturer

Istanbul University - Cerrahpasa

研究点 (2)

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