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Completed

NCT Number: NCT06538987

Anesthetic Management in Patients Undergoing Epicardial Ablation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Eskisehir Osmangazi

Eskişehir, Odunpazarı, 26040, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

• age > 18 years old who underwent elective VT ablation between 2020 - 2022,

  • primary anesthetic type listed as general anesthesia

Exclusion criteria

• age < 18 years,

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

Treatment and study plan

percutaneous epicardial ablation

Procedure

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.

Primary outcomes

  1. sex

    Time frame: 2 years

    male %

  2. age

    Time frame: 2 years

    years

  3. weight

    Time frame: 2 years

    kilograms

  4. height

    Time frame: 2 years

    meters

  5. Hypertension

    Time frame: 2 years

    yes or no

  6. Diabetes mellitus

    Time frame: 2 years

    yes or no

  7. Coronary artery disease

    Time frame: 2 years

    yes or no

  8. Chronic obstructive pulmonary disease

    Time frame: 2 years

    yes or no

  9. Chronic kidney disease

    Time frame: 2 years

    yes or no

  10. Systolic pulmonary artery pressure

    Time frame: 2 years

    mmHg

  11. Left ventricular ejection

    Time frame: 2 years

    %

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

    Time frame: 2 years

    score 0-35

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

    Time frame: 2 years

    score I-IV

  14. Hemoglobin

    Time frame: 2 years

    g/dl

  15. glomerular filtration rate (eGFR)

    Time frame: 2 years

    ml/dak/1,73m2

  16. Total procedural time

    Time frame: 2 years

    minutes

  17. Fluoroscopy time

    Time frame: 2 years

    minutes

  18. Ablation time

    Time frame: 2 years

    minutes

Secondary outcomes

  1. Transient ischemic attack after procedure

    Time frame: 2 years

    yes or no

  2. Exitus during the follow-up

    Time frame: 2 years

    yes or no

  3. cause of death

    Time frame: 2 years

    End-Stage heart failure, VT storm

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 6, 2024
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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