- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07603765
Minimally Invasive Hemodynamic Monitoring in Cardiac Ablation
Prospective Clinical Study of Minimally Invasive Hemodynamic Monitoring Outcomes in Cardiac Ablation Procedures
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: GOZDE ALTUN
- Telefonnummer: +905544290333
- E-mail: gozde.altun@iuc.edu.tr
Studiesteder
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Istanbul, Tyrkiet (Türkiye)
- Rekruttering
- Istanbul University-Cerrahpasa, Institute of Cardiology
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Kontakt:
- GOZDE ALTUN
- Telefonnummer: +905544290333
- E-mail: gozde.altun@iuc.edu.tr
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Cardiac Output measured by PRAM during catheter ablation
Tidsramme: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
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Cardiac output (L/min) measured using the PRAM-based monitoring system during catheter ablation procedures under non-operating room anesthesia.
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Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Cardiac Index During Catheter Ablation
Tidsramme: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
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Cardiac index (L/min/m²) measured using the PRAM-based monitoring system at predefined procedural time points.
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Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
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Change in Stroke Volume During Catheter Ablation
Tidsramme: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
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Stroke volume (mL/beat) measured using PRAM-based hemodynamic monitoring during the procedure.
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Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
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|
Change in Mean Arterial Pressure During Catheter Ablation
Tidsramme: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
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Mean arterial pressure (mmHg) measured invasively and analyzed during the procedure.
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Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
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Change in Systemic Vascular Resistance During Catheter Ablation
Tidsramme: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
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Systemic vascular resistance (dyn·s/cm⁵) measured using PRAM-based monitoring during catheter ablation.
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Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
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Change in Stroke Volume Variation During Catheter Ablation
Tidsramme: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
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Stroke volume variation (%) measured using the PRAM system during the procedure
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Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
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Change in Pulse Pressure Variation During Catheter Ablation
Tidsramme: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
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Pulse pressure variation (%) measured continuously during catheter ablation procedures.
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Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
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Change in dP/dt max During Catheter Ablation
Tidsramme: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
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Maximum arterial pressure rise over time (dP/dt max, mmHg/s) measured using PRAM-based analysis.
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Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
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Change in Cardiac Cycle Efficiency During Catheter Ablation
Tidsramme: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
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Cardiac cycle efficiency (%) assessed using the PRAM-based monitoring system during catheter ablation.
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Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Kerem Erkalp, Istanbul University-Cerrahpasa, Institute of Cardiology
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 018
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