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

NCT ID: NCT06283654

Last Updated: 2024-04-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 204 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-30
• Study Completion Date: 2023-01-31

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.

Detailed Description

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.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

1-lead ECG group

Patients after PVI that received a 1-lead ECG

1-lead ECG

Intervention Type: DEVICE

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

standard care group

standard care group

No interventions assigned to this group

Interventions

1-lead ECG

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• AF and PVI

Exclusion Criteria

• <18y

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: lead

Responsible Party

Luuk Hopman

prof dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Amsterdam UMC -vumc

Amsterdam, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 39705212 (View on PubMed)

Other Identifiers

VUmc 2018.539

Identifier Type: -

Identifier Source: org_study_id