Istanbul University-Cerrahpasa, Institute of Cardiology
Istanbul, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07603765
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Istanbul, Turkey (Türkiye)
Location status: Recruiting
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Continuous beat-to-beat hemodynamic monitoring using the Pressure Recording Analytical Method (PRAM) via an invasive arterial line.
Time frame: 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.
Time frame: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
Cardiac index (L/min/m²) measured using the PRAM-based monitoring system at predefined procedural time points.
Time frame: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
Stroke volume (mL/beat) measured using PRAM-based hemodynamic monitoring during the procedure.
Time frame: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
Mean arterial pressure (mmHg) measured invasively and analyzed during the procedure.
Time frame: 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.
Time frame: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
Stroke volume variation (%) measured using the PRAM system during the procedure
Time frame: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
Pulse pressure variation (%) measured continuously during catheter ablation procedures.
Time frame: 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.
Time frame: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
Cardiac cycle efficiency (%) assessed using the PRAM-based monitoring system during catheter ablation.
Contact information is provided by the study sponsor or research team.
Istanbul University - Cerrahpasa
Other
Prospective Clinical Study of Minimally Invasive Hemodynamic Monitoring Outcomes in Cardiac Ablation Procedures
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