Minimally Invasive Hemodynamic Monitoring in Cardiac Ablation

NCT07603765 | Recruiting

• 1 other identifier: 018
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Arrythmias; Anesthesia

Keywords

catheter ablation; anesthesiology; conscious Sedation; deep sedation; hemodynamic monitoring

Outcome Measures

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.

  Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)

Secondary Outcomes (8)

• Change in Cardiac Index During Catheter Ablation

  Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)

• Change in Stroke Volume During Catheter Ablation

  Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)

• Change in Mean Arterial Pressure During Catheter Ablation

  Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)

• Change in Systemic Vascular Resistance During Catheter Ablation

  Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)

• Change in Stroke Volume Variation During Catheter Ablation

  Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)

Interventions

Minimally invasive hemodynamic monitoring OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa, Institute of Cardiology

Istanbul, Turkey (Türkiye)

RECRUITING

Study Officials

• Kerem Erkalp

  Istanbul University-Cerrahpasa, Institute of Cardiology

  STUDY CHAIR

Central Study Contacts

GOZDE ALTUN

CONTACT

+905544290333; gozde.altun@iuc.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 22, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

TU (1)