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Ventricular TachycardiaNCT06538987

Anesthetic Management in Patients Undergoing Epicardial Ablation

An observational study of Ventricular Tachycardia, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is a retrospective study and is descriptive in nature. In this study, the investigators aimed to emphasize the importance of anesthesia management by cardiac risk assessment of patients undergoing epicardial ablation under general anesthesia and analysis of complications that developed during the procedure. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Ventricular Tachycardia
What is being tested?
percutaneous epicardial ablation
Type of treatment
Surgery or procedure
How many people
22 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Aug 2024to 30 Oct 2024
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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Since it is a retrospective study, patients who underwent epicardial ablation within the specified date range will be included. Although the estimated number of cases cannot be predicted, it is a rare and specialized procedure. No group has been determined, the characteristics of the patients and their anesthesia management will be examined in an observational study.

Who may be able to join

None listed.

Who cannot join

  • missing follow-up data,
  • patients who have previously undergone epicardial ablation

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • University of Eskisehir Osmangazi

    Eskişehir, Odunpazarı, 26040

Other trials in Turkey (Türkiye)

About this study

Official title: Anesthetic Management in Patients Undergoing Epicardial Ablation for the Treatment of Ventricular Tachycardia; Retrospective Study

The study is a retrospective study and is descriptive in nature. In this study, the investigators aimed to emphasize the importance of anesthesia management by cardiac risk assessment of patients undergoing epicardial ablation under general anesthesia and analysis of complications that developed during the procedure.

Read the detailed description

The study is retrospective observational and data were collected by examining the files of all epicardial ablation patients received in the angiography unit starting from 30.10.2020 until 30.10.2022 after ethics committee approval is obtained. Baseline characteristic features of the patients Sex, Age, (years, BMI (kg/m2) Hypertension, Coronary artery disease, COPD (Chronic obstructive pulmonary disease), CKD (Chronic kidney disease) Electrical storm, and ventricular tachycardia etiology, Ischemic cardiomyopathy, Dilated cardiomyopathy, the presence of ARVC (Arrhythmogenic Right Ventricular Cardiomyopathy), Hypertrophic cardiomyopathy will be recorded. NHYA classification will be examined in two groups as NHYA I or II and NHYA III or IV, also estimated glomerular filtration rate, left ventricular ejection fraction, PAAINESD (acute hemodynamic decompensation risk assessment score), iVT score (Risk of VT recurrence) Score information will be recorded. Ventricular tachycardia focus locations, dopamine, dobutamine, norepinephrine infusion requirement during the procedure, arrest development during the procedure, fluoroscopy time and ablation times will be recorded. In the follow-up of the patients after the procedure Causes of death, decompensated heart failure, transient ischemic attack, development of acute renal failure, and recurrence of ventricular tachycardia will be recorded. PAAINESD score (acute hemodynamic decompensation risk assessment score) will be recorded. The PAAINESD Score, developed to estimate the risk of periprocedural hemodynamic decompensation, has values ranging from 0 to 35 points (or 0 to 31 [PAINESD] when the modifiable intraprocedural variable "general anesthesia" is excluded). duration of the procedure, the need for inotropes during the procedure, whether the patient needed mechanical ventilation after the procedure, and the success rates after the procedure will be recorded.

PAINESD Pulmonary disease (chronic obstructive pulmonary disease) 5 Age >60 years 3 Anaesthesia (general) 4 Ischaemic cardiomyopathy 6 NYHA class III or IV 6 Ejection fraction <25 % 3 Storm (VT). 5 Diabetes 3 Data will be analyzed in three separate categories, the characteristics of the patients before the procedure, during the procedure and after the procedure. Descriptive tables and percentages of parameters will be created by statistical analysis.

Being tested
percutaneous epicardial ablation
Keywords
anesthesia, ventricular tachycardia, Electrophysiology, electro-anatomic mapping, catheter ablation, risk assessment
Medical subject headings
Tachycardia, Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • percutaneous epicardial ablationProcedure or surgery

    Epicardial catheter ablation is often necessary for the successful treatment of scar-induced ventricular tachycardia (VT), especially in patients with nonischemic cardiomyopathy (NICMP) where scarring is more extensive on the mid-myocardial or epicardial surface. Because epicardial mapping can be painful and patient movement can limit mapping and safe epicardial access, a common strategy for these patients is general anesthesia.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. sex

    male %

    Measured: 2 years

  2. age

    years

    Measured: 2 years

  3. weight

    kilograms

    Measured: 2 years

  4. height

    meters

    Measured: 2 years

  5. Hypertension

    yes or no

    Measured: 2 years

  6. Diabetes mellitus

    yes or no

    Measured: 2 years

  7. Coronary artery disease

    yes or no

    Measured: 2 years

  8. Chronic obstructive pulmonary disease

    yes or no

    Measured: 2 years

  9. Chronic kidney disease

    yes or no

    Measured: 2 years

  10. Systolic pulmonary artery pressure

    mmHg

    Measured: 2 years

  11. Left ventricular ejection

    %

    Measured: 2 years

  12. PAAINESD (Acute hemodynamic decompensation risk assessment, ranging from 0 to 35 points, 35 point is the worst) score

    score 0-35

    Measured: 2 years

  13. ASA ( American Society of Anesthesiologists (ASA) physical status classification ranging from I to IV

    score I-IV

    Measured: 2 years

  14. Hemoglobin

    g/dl

    Measured: 2 years

  15. glomerular filtration rate (eGFR)

    ml/dak/1,73m2

    Measured: 2 years

  16. Total procedural time

    minutes

    Measured: 2 years

  17. Fluoroscopy time

    minutes

    Measured: 2 years

  18. Ablation time

    minutes

    Measured: 2 years

Secondary outcomes (3)

  1. Transient ischemic attack after procedure

    yes or no

    Measured: 2 years

  2. Exitus during the follow-up

    yes or no

    Measured: 2 years

  3. cause of death

    End-Stage heart failure, VT storm

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2024
  2. Study start30 Aug 2024
  3. Primary completion30 Sep 2024
  4. Study completion30 Oct 2024

Resources

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
Retrospective
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06538987
Sponsor's protocol ID
EskisehirU
Status last verified
Mar 2025
First submitted
8 Jul 2024
Last updated
2 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Ventricular Tachycardia, run by Eskisehir Osmangazi University 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 0 inclusion and 2 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 2 May 2025. 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?

sex (time frame: 2 years). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06538987.

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 2 May 2025.

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