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Minimally Invasive Hemodynamic Monitoring in Cardiac Ablation

14 de setembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Descrição detalhada

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 de estudo

Observacional

Inscrição (Real)

27

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Istanbul, Turquia (Türkiye)
        • Istanbul University-Cerrahpasa, Institute of Cardiology

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

N/D

Método de amostragem

Amostra Não Probabilística

População do estudo

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

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Cardiac Output measured by PRAM during catheter ablation
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Stroke Volume During Catheter Ablation
Prazo: 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
Prazo: 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
Prazo: 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 dP/dt max During Catheter Ablation
Prazo: 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
Prazo: 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)
Change in Arterial Elastance
Prazo: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
Change in arterial elastance derived from PRAM across predefined procedural periods: before, during, and after catheter ablation. Arterial elastance will be expressed as mmHg/mL.
Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Cadeira de estudo: Kerem Erkalp, Istanbul University-Cerrahpasa, Institute of Cardiology

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

30 de abril de 2026

Conclusão Primária (Real)

15 de agosto de 2026

Conclusão do estudo (Real)

4 de setembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

4 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de maio de 2026

Primeira postagem (Real)

22 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

17 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

14 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 018

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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