Cardiac ArrythmiasNCT07603765
Minimally Invasive Hemodynamic Monitoring in Cardiac Ablation
An observational study of Cardiac Arrythmias and Anesthesia, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrythmias, Anesthesia
- What is being tested?
- Minimally invasive hemodynamic monitoring
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2026to 4 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients undergoing cardiac catheter ablation in an electrophysiology laboratory with minimally invasive hemodynamic monitoring.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa, Institute of Cardiology
Istanbul
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Cardiac Arrythmias, Anesthesia
- Being tested
- Minimally invasive hemodynamic monitoring
- Keywords
- catheter ablation, anesthesiology, conscious Sedation, deep sedation, hemodynamic monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive hemodynamic monitoringOther
Continuous beat-to-beat hemodynamic monitoring using the Pressure Recording Analytical Method (PRAM) via an invasive arterial line.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
Secondary outcomes (6)
Change in Stroke Volume During Catheter Ablation
Stroke volume (mL/beat) measured using PRAM-based hemodynamic monitoring during the procedure.
Measured: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
Change in Mean Arterial Pressure During Catheter Ablation
Mean arterial pressure (mmHg) measured invasively and analyzed during the procedure.
Measured: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
Change in Systemic Vascular Resistance During Catheter Ablation
Systemic vascular resistance (dyn·s/cm⁵) measured using PRAM-based monitoring during catheter ablation.
Measured: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
Change in dP/dt max During Catheter Ablation
Maximum arterial pressure rise over time (dP/dt max, mmHg/s) measured using PRAM-based analysis.
Measured: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
Change in Cardiac Cycle Efficiency During Catheter Ablation
Cardiac cycle efficiency (%) assessed using the PRAM-based monitoring system during catheter ablation.
Measured: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
Change in Arterial Elastance
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.
Measured: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start30 Apr 2026
- Primary completion15 Aug 2026
- Study completion4 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrythmiasStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gozde Altun, Istanbul University - Cerrahpasa
- Investigators
- Kerem Erkalp, Study chair, Istanbul University-Cerrahpasa, Institute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603765
- Sponsor's protocol ID
- 018
- Status last verified
- Sep 2026
- First submitted
- 4 May 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study of Minimally Invasive Hemodynamic Monitoring Outcomes in Cardiac Ablation Procedures
- ClinicalTrials.gov ID
- NCT07603765
- Acronym / sponsor ID
- 018
- Conditions
- Cardiac Arrythmias, Anesthesia
- Keywords
- catheter ablation, anesthesiology, conscious Sedation, deep sedation, hemodynamic monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 15 Aug 2026 (actual)
- Study completion
- 4 Sep 2026 (actual)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing cardiac catheter ablation in an electrophysiology laboratory with minimally invasive hemodynamic monitoring.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally invasive hemodynamic monitoringContinuous beat-to-beat hemodynamic monitoring using the Pressure Recording Analytical Method (PRAM) via an invasive arterial line. | Other | – |
Primary outcome
Change in Cardiac Output measured by PRAM during catheter ablation
Time frame: 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.
6 secondary outcomes
Change in Stroke Volume During Catheter Ablation
Time frame: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
Change in Mean Arterial Pressure During Catheter Ablation
Time frame: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
Change in Systemic Vascular Resistance During Catheter Ablation
Time frame: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
Change in dP/dt max During Catheter Ablation
Time frame: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
Change in Cardiac Cycle Efficiency During Catheter Ablation
Time frame: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
Change in Arterial Elastance
Time frame: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
Related trials for Cardiac Arrythmias
RecruitingObservational study
RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)
Cardiac Arrythmias
RecruitingObservational study
Quality of Life Before and After Transcatheter Ablation in Children With Arrythmias
Arrhythmia
RecruitingObservational study
Tezspire Cardiac Events PASS
Cardiovascular Events, MACE
Not yet recruiting
Assessment of Heart Rate Variability HRV During Descent DE From 2850m to Sea Level and During Re-ascent A From Sea Level to 2850m in Patients With Pulmonary Arterial Hypertension PAH
High Altitude Effects, High Altitude
Recruiting
Agilis RF TSP Early Feasibility Study
Cardiac Arrythmias, Left Atrial Appendage Closure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerem Erkalp study chair
Istanbul University-Cerrahpasa, Institute of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrythmias and Anesthesia, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cardiac Output measured by PRAM during catheter ablation (time frame: Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.