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Minimally Invasive Hemodynamic Monitoring in Cardiac Ablation

21 maggio 2026 aggiornato da: Gozde Altun, Istanbul University - Cerrahpasa

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.

Panoramica dello studio

Stato

Reclutamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

27

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

      • Istanbul, Turchia (Türkiye)
        • Reclutamento
        • Istanbul University-Cerrahpasa, Institute of Cardiology
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

N/A

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Cardiac Output measured by PRAM during catheter ablation
Lasso di tempo: 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.
Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Cardiac Index During Catheter Ablation
Lasso di tempo: 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.
Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
Change in Stroke Volume During Catheter Ablation
Lasso di tempo: Intra-procedural (T0: before ablation, T1: during ablation, T2: after 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
Lasso di tempo: Intra-procedural (T0: before ablation, T1: during ablation, T2: after 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
Lasso di tempo: 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.
Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
Change in Stroke Volume Variation During Catheter Ablation
Lasso di tempo: Intra-procedural (T0: before ablation, T1: during ablation, T2: after 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
Lasso di tempo: Intra-procedural (T0: before ablation, T1: during ablation, T2: after 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
Lasso di tempo: 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.
Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
Change in Cardiac Cycle Efficiency During Catheter Ablation
Lasso di tempo: Intra-procedural (T0: before ablation, T1: during ablation, T2: after 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Cattedra di studio: Kerem Erkalp, Istanbul University-Cerrahpasa, Institute of Cardiology

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

30 aprile 2026

Completamento primario (Stimato)

15 novembre 2026

Completamento dello studio (Stimato)

15 dicembre 2026

Date di iscrizione allo studio

Primo inviato

4 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 maggio 2026

Primo Inserito (Effettivo)

22 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 018

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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