Device-based rate versus rhythm control treatment in patients with symptomatic recent-onset atrial fibrillation in the emergency department (RACE 9)

Recruiting

• Conditions: atrial fibrillation; 10007521; cardiac arrhythmia

• Registration Number: NL-OMON55214
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 490

Inclusion Criteria

• ECG with atrial fibrillation within 6 hours from presentation to the ED
• Duration of the AF episode <36 hours
• Symptoms due to atrial fibrillation
• Age > 18 years
• Able and willing to sign informed consent
• Able and willing to use telemetric rhythm recorder

Exclusion Criteria

• History of persistent AF (episode of AF lasting more than 48 hours and
terminated by cardioversion)
• Deemed unsuitable for participation by attending physician
• Hemodynamic instability (heart rate >170 bpm, systolic blood pressure <100
mmHg)
• Acute heart failure
• Signs of myocardial infarction
• History of syncope of unexplained origin
• History of untreated Sick Sinus Syndrome
• History of untreated Wolff-Parkinson-White syndrome
• Currently enrolled in another clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>the primary endpoint is the presence of sinus rhythm on the electrocardiogram<br /><br>(ECG) at 4 weeks. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are the number of transmissions from the telemonitoring<br /><br>infrastructure, accuracy of the automatic red-amber-green alert system, AF<br /><br>recurrences and progression, adverse events, costs, quality of life and<br /><br>predictive value of extended electrocardiography for AF progression and<br /><br>spontaneous conversion. </p><br>