Minimally Invasive Hemodynamic Monitoring in Cardiac Ablation
Prospective Clinical Study of Minimally Invasive Hemodynamic Monitoring Outcomes in Cardiac Ablation Procedures
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
-
Istanbul、土耳其(türkiye)
- Istanbul University-Cerrahpasa, Institute of Cardiology
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Cardiac Output measured by PRAM during catheter ablation
大体时间:Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
|
Cardiac output (L/min) measured using the PRAM-based monitoring system during catheter ablation procedures under non-operating room anesthesia.
|
Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Stroke Volume During Catheter Ablation
大体时间:Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
|
Stroke volume (mL/beat) measured using PRAM-based hemodynamic monitoring during the procedure.
|
Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
|
|
Change in Mean Arterial Pressure During Catheter Ablation
大体时间:Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
|
Mean arterial pressure (mmHg) measured invasively and analyzed during the procedure.
|
Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
|
|
Change in Systemic Vascular Resistance During Catheter Ablation
大体时间:Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
|
Systemic vascular resistance (dyn·s/cm⁵) measured using PRAM-based monitoring during catheter ablation.
|
Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
|
|
Change in dP/dt max During Catheter Ablation
大体时间:Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
|
Maximum arterial pressure rise over time (dP/dt max, mmHg/s) measured using PRAM-based analysis.
|
Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
|
|
Change in Cardiac Cycle Efficiency During Catheter Ablation
大体时间:Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
|
Cardiac cycle efficiency (%) assessed using the PRAM-based monitoring system during catheter ablation.
|
Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
|
|
Change in Arterial Elastance
大体时间:Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
|
Change in arterial elastance derived from PRAM across predefined procedural periods: before, during, and after catheter ablation.
Arterial elastance will be expressed as mmHg/mL.
|
Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
|
合作者和调查者
调查人员
- 学习椅:Kerem Erkalp、Istanbul University-Cerrahpasa, Institute of Cardiology
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 018
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.