Minimally Invasive Hemodynamic Monitoring in Cardiac Ablation

Istanbul University - Cerrahpasa

Status: Enrolling

Conditions: Cardiac Arrythmias; Anesthesia

Treatments: Other: Minimally invasive hemodynamic monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT07603765

018

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 27 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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