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

NCT06283654 | Completed

• 1 other identifier: VUmc 2018.539
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

1-lead ECG; ED visits

Outcome Measures

Primary Outcomes (1)

• number of ED visits

  1 year after PVI

Secondary Outcomes (1)

• ratio of the number of cardioversions emergency vs planned

  1 year after PVI

Study Arms (2)

1-lead ECG group

Patients after PVI that received a 1-lead ECG

Device: 1-lead ECG

standard care group

standard care group

Interventions

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

1-lead ECG group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with all kinds of AF who underwent a PVI

You may qualify if:

• AF and PVI

You may not qualify if:

• \<18y

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

Amsterdam UMC -vumc

Amsterdam, Netherlands

Location

Related Publications (1)

• Selder JL, Mulder MJ, van de Vijver WR, Croon PM, Wentrup LE, van der Pas SL, Twisk JWR, Tulevski II, Van Rossum AC, Allaart CP. Does providing atrial fibrillation patients, after pulmonary vein isolation, with a 1-lead ECG device relieve the emergency department?-A historically controlled prospective trial. PLOS Digit Health. 2024 Dec 20;3(12):e0000688. doi: 10.1371/journal.pdig.0000688. eCollection 2024 Dec.

  PMID: 39705212 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof dr

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start: September 30, 2018
• Primary Completion: September 30, 2021
• Study Completion: January 31, 2023
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

NL (1)