Cerebral Oxygen Saturation Measurement During Cardioversion Because of Atrial Fibrillation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Near infrared spectroscopy (NIRS) is a technique that measures regional cerebral oxygenation in a non-invasive manner. Through the use of near infrared light, the difference between oxygenated and deoxygenated hemoglobin can be measured. By applying the Lambert-Beer law, a numeric result can be calculated.

Since atrial fibrillation (AF) has been linked with an increased risk for the development of neurocognitive deficits, a longer period of AF might be associated with a higher risk for neurocognitive deficits.

It is hypothesized that there is an increase in the regional cerebral oxygen saturation (rSO2) of patients with paroxysmal or persistent AF after successful cardioversion.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

NIRS in Congenital Heart Defects - Correlation With Echocardiography

NCT04106479

Congenital Heart Defect Single-ventricle Coarctation of Aorta +8 more

RECRUITING

Validation of Kinocardiography, New Technology for Cardiac Linear and Torsional Contractility Measurement, to Assess Heart Failure Patient With Low Ejection Fraction

NCT03157115

Impaired Left Ventricular Ejection Fraction

COMPLETED NA

Deep Learning for Intelligent Identification of Arrhythmias

NCT05967546

Arrhythmia

NOT_YET_RECRUITING

AI-Based Prediction of Atrial Fibrillation in ESUS Patients With ICM

NCT07347691

Embolic Stroke of Undetermined Source

RECRUITING

Artificial Intelligence (AI) Analysis of Synchronized Phonocardiography (PCG) and Electrocardiogram(ECG)

NCT06009718

Heart Failure

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Written informed consent by the patient is asked before cardioversion and participation in the study. Patient anamnesis is assessed by standardized questionnaire.

Patients perform several standardised neurocognitive tests to obtain a general view on the neurocognitive status (auditory verbal learning test, mini-mental state examination, trail making A and B, digit-symbol coding and RAND 36 Health Survey).

Cerebral oxygenation is observed during cardioversion by means of the SenSmart Model X-100 (Nonin). Additional parameters (pulse oximetry, cardiac output, arterial blood pressure, 6-lead electrocardiography (ECG), left ventricular ejection fraction) are recorded. All measurements are performed non-invasively. Patients receive standard treatment following the clinical guidelines.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Electrical Cardioversion of Atrial Fibrillation Pharmacological Cardioversion of Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

electrical cardioversion

Hemodynamic unstable patients with atrial fibrillation who are scheduled to undergo electrical reconversion to convert their irregular heart rhythm into a normal sinus rhythm. Cerebral tissue oxygen saturation is measured by means of SenSmart Model X-100, Nonin Medical.

Group Type OTHER

SenSmart Model X-100, Nonin Medical

Intervention Type DEVICE

Device to measure cerebral tissue oxygen saturation

pharmacological cardioversion

Patients who develop atrial fibrillation after cardiac surgery. Pharmacological treatment with amiodarone is started in order to convert their irregular heart rhythm into a normal sinus rhythm. Cerebral tissue oxygen saturation is measured by means of SenSmart Model X-100, Nonin Medical.

Group Type OTHER

SenSmart Model X-100, Nonin Medical

Intervention Type DEVICE

Device to measure cerebral tissue oxygen saturation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SenSmart Model X-100, Nonin Medical

Device to measure cerebral tissue oxygen saturation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* older than 18 years and able to give informed consent
* diagnosis of paroxysmal or persistent atrial fibrillation
* scheduled for electrical cardioversion or atrial fibrillation development in the first days after cardiac surgery followed by pharmacological treatment with amiodarone
* Dutch speaking

Exclusion Criteria

* younger than 18 years or not able to give informed consent
* diagnosis of permanent atrial fibrillation
* atrial fibrillation with thrombus in left atrial appendage
* chronic obstructive pulmonary disease GOLD class 3 or 4
* airway manipulation during cardioversion
* pregnant women
* medical history of cerebrovascular accident or brain injury
* medical history of cardiopulmonary resuscitation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No