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OpenTrials
Completed

NCT Number: NCT06283654

Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation

In this study, the researchers explored a new approach to manage atrial fibrillation, a disease that affects millions worldwide. The goal was to see if using a simple handheld ECG device for monitoring heart rhythm could help patients avoid unnecessary visits to the emergency department (ED) after undergoing a common procedure known as pulmonary vein isolation (PVI). This procedure is often used to treat AF, but following it patients frequently visit the ED due to concerns about their heart rhythm, which can strain healthcare resources. The researchers proved a group of patients with a 1-lead ECG device , which allowed users to check their heart rhythm at any time. The researchers compared the ED utilization over a year with that of patients who received standard care after PVI. The hope was that by using the 1-lead ECG device, patients could better manage their condition from home and only seek medical help when truly necessary.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam UMC -vumc

Amsterdam, Netherlands

About this study

Atrial fibrillation (AF) is a prevalent and clinically significant cardiac arrhythmia, with a growing incidence. The primary objectives in AF management are symptom relief, stroke risk reduction, and prevention of tachycardia-induced cardiomyopathy. Two key strategies for rhythm control include antiarrhythmic drug therapy and pulmonary vein isolation (PVI), with PVI being recommended for selected patients. Even though PVI is effective, post procedural health care utilization is high, contributing to emergency department (ED) overcrowding, which is a global healthcare concern. The use of remote rhythm diagnostics, such as a 1-lead ECG device, may mitigate this issue by reducing ED visits and facilitating more plannable AF care. Objective: This study aimed to assess whether providing AF patients with a 1-lead ECG device for 1 year after PVI would reduce ED utilization compared to standard care. Additionally, the study assessed whether this would enhance plannability of AF related healthcare utilization. Methods: A historically controlled, prospective clinical trial was conducted. The 'intervention' group are patients undergoing PVI for AF, all patients in this group receive a KM device for 1 year for remote rhythm monitoring. The historical control group were patients undergoing PVI between January 2016 and December 2017; these patients did not receive a KM. Data on ED visits, planned and unplanned cardioversions, and outpatient contacts in the year after the PVI were collected for both groups.

Who can participate

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

Inclusion criteria

  • AF and PVI

Exclusion criteria

  • <18y

Treatment and study plan

1-lead ECG

Device

patient were handed out a 1 lead ECG device, they were free to use it anyway they wanted, even not at all

Primary outcomes

  1. number of ED visits

    Time frame: 1 year after PVI

Secondary outcomes

  1. ratio of the number of cardioversions emergency vs planned

    Time frame: 1 year after PVI

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Official study title

Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation: a Historically Controlled Prospective Trial

Acronym: relievED

Important dates

Study start
2018
Primary completion
2021
Study completion
2023
First posted
Feb 28, 2024
Registry last updated
Apr 26, 2024

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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