Minimally Invasive Hemodynamic Monitoring in Cardiac Ablation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstanbul University - Cerrahpasa
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adult patients undergoing cardiac catheter ablation in an electrophysiology laboratory with minimally invasive hemodynamic monitoring.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Minimally invasive hemodynamic monitoring
Other interventionContinuous beat-to-beat hemodynamic monitoring using the Pressure Recording Analytical Method (PRAM) via an invasive arterial line.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)Secondary outcomes
1
Change in Cardiac Index During Catheter 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)2
Change in Stroke Volume During Catheter 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)3
Change in Mean Arterial Pressure During Catheter 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)4
Change in Systemic Vascular Resistance During Catheter 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)Sponsors and contacts
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Source ClinicalTrials.gov