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NCT Number: NCT07603765

Minimally Invasive Hemodynamic Monitoring in Cardiac Ablation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University-Cerrahpasa, Institute of Cardiology

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

GOZDE ALTUN

CONTACT

[email protected]

+905544290333

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minimally invasive hemodynamic monitoring

Other

Continuous beat-to-beat hemodynamic monitoring using the Pressure Recording Analytical Method (PRAM) via an invasive arterial line.

Primary outcomes

  1. Change in Cardiac Output measured by PRAM during catheter ablation

    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.

Secondary outcomes

  1. Change in Cardiac Index During Catheter Ablation

    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.

  2. Change in Stroke Volume During Catheter Ablation

    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.

  3. Change in Mean Arterial Pressure During Catheter Ablation

    Time frame: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)

    Mean arterial pressure (mmHg) measured invasively and analyzed during the procedure.

  4. Change in Systemic Vascular Resistance During Catheter Ablation

    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.

  5. Change in Stroke Volume Variation 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

  6. Change in Pulse Pressure Variation During Catheter Ablation

    Time frame: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)

    Pulse pressure variation (%) measured continuously during catheter ablation procedures.

  7. Change in dP/dt max During Catheter Ablation

    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.

  8. Change in Cardiac Cycle Efficiency During Catheter Ablation

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

GOZDE ALTUN

CONTACT

[email protected]

+905544290333

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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