Minimally Invasive Hemodynamic Monitoring in Cardiac Ablation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia; Cardiac Arrythmias
• Intervention / Treatment: Other: Minimally invasive hemodynamic monitoring

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 27

Contacts and Locations

• Study Contact: Name: GOZDE ALTUN; Phone Number: +905544290333; Email: gozde.altun@iuc.edu.tr

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Recruiting
    • Istanbul University-Cerrahpasa, Institute of Cardiology
    • Contact: GOZDE ALTUN; Phone Number: +905544290333; Email: gozde.altun@iuc.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing cardiac catheter ablation in an electrophysiology laboratory with minimally invasive hemodynamic monitoring.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cardiac Output measured by PRAM during catheter 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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cardiac Index During Catheter Ablation	Cardiac index (L/min/m²) measured using the PRAM-based monitoring system at predefined procedural time points.	Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
Change in Stroke Volume During Catheter 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	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	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 Stroke Volume Variation During Catheter Ablation	Stroke volume variation (%) measured using the PRAM system during the procedure	Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
Change in Pulse Pressure Variation During Catheter Ablation	Pulse pressure variation (%) measured continuously during catheter ablation procedures.	Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
Change in dP/dt max During Catheter 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	Cardiac cycle efficiency (%) assessed using the PRAM-based monitoring system during catheter ablation.	Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa
• Investigators: Study Chair: Kerem Erkalp, Istanbul University-Cerrahpasa, Institute of Cardiology

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: catheter ablation; hemodynamic monitoring; deep sedation; anesthesiology; conscious Sedation
• Other Study ID Numbers: 018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No