Anesthetic Management in Patients Undergoing Epicardial Ablation

May 1, 2025 updated by: Ferda YAMAN, Eskisehir Osmangazi University

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.

Study Overview

Status

Completed

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.

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Odunpazarı
      • Eski̇şehi̇r, Odunpazarı, Turkey, 26040
        • University of Eskisehir Osmangazi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight
Time Frame: 2 years
kilograms
2 years
sex
Time Frame: 2 years
male %
2 years
age
Time Frame: 2 years
years
2 years
height
Time Frame: 2 years
meters
2 years
Hypertension
Time Frame: 2 years
yes or no
2 years
Diabetes mellitus
Time Frame: 2 years
yes or no
2 years
Coronary artery disease
Time Frame: 2 years
yes or no
2 years
Chronic obstructive pulmonary disease
Time Frame: 2 years
yes or no
2 years
Chronic kidney disease
Time Frame: 2 years
yes or no
2 years
Systolic pulmonary artery pressure
Time Frame: 2 years
mmHg
2 years
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
2 years
ASA ( American Society of Anesthesiologists (ASA) physical status classification ranging from I to IV
Time Frame: 2 years
score I-IV
2 years
Hemoglobin
Time Frame: 2 years
g/dl
2 years
glomerular filtration rate (eGFR)
Time Frame: 2 years
ml/dak/1,73m2
2 years
Total procedural time
Time Frame: 2 years
minutes
2 years
Fluoroscopy time
Time Frame: 2 years
minutes
2 years
Ablation time
Time Frame: 2 years
minutes
2 years
Left ventricular ejection
Time Frame: 2 years
%
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transient ischemic attack after procedure
Time Frame: 2 years
yes or no
2 years
Exitus during the follow-up
Time Frame: 2 years
yes or no
2 years
cause of death
Time Frame: 2 years
End-Stage heart failure, VT storm
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: ferda yaman, Assoc prof, University of Eskisehir Osmangazi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2024

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

October 30, 2024

Study Registration Dates

First Submitted

July 8, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 2, 2025

Last Update Submitted That Met QC Criteria

May 1, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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