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Recruiting NCT07603765

Minimally Invasive Hemodynamic Monitoring in Cardiac Ablation

Observational Cardiac Arrythmias Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Minimally invasive hemodynamic monitoring.
Who it may be relevant to
Registry conditions: Cardiac Arrythmias, Anesthesia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

  • Change in Cardiac Output measured by PRAM during catheter ablation [Time frame: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)]
Secondary outcome measures (8)
  • Change in Cardiac Index During Catheter Ablation [Time frame: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)]
  • Change in Stroke Volume During Catheter Ablation [Time frame: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)]
  • Change in Mean Arterial Pressure During Catheter Ablation [Time frame: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)]
  • Change in Systemic Vascular Resistance During Catheter Ablation [Time frame: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)]
  • Change in Stroke Volume Variation During Catheter Ablation [Time frame: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)]
  • Change in Pulse Pressure Variation During Catheter Ablation [Time frame: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)]
  • Change in dP/dt max During Catheter Ablation [Time frame: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)]
  • Change in Cardiac Cycle Efficiency During Catheter Ablation [Time frame: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Istanbul University-Cerrahpasa, Institute of Cardiology — Istanbul

Identifiers

NCT: NCT07603765 · 018

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗