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Acute Cardioversion Versus Wait And See-approach for Symptomatic Atrial Fibrillation in the Emergency Department

Information source: Maastricht University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atrial Fibrillation

Intervention: Pharmacological cardioversion (Drug); Electrical cardioversion (Procedure); Metoprolol (Drug); Verapamil (Drug); Digoxin (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Maastricht University Medical Center

Official(s) and/or principal investigator(s):
Harry J Crijns, MD, PhD, Principal Investigator, Affiliation: Maastricht University Medical Center

Overall contact:
Elton Dudink, MD, Phone: +31433875119, Email: elton.dudink@mumc.nl

Summary

A symptomatic episode of the heart rhythm disorder 'atrial fibrillation' (AF) is a frequent reason for visits to the emergency department. Currently, in the majority of cases, immediate (electrical or pharmacological) cardioversion is chosen, while atrial fibrillation terminates spontaneously in 70% of the cases within 24 hours. A wait-and-see approach with rate-control medication only, and when needed cardioversion within 48 hours of onset of symptoms, could be effective, safe and more cost-effective than current standard of care and could lead to a higher quality of life.

Clinical Details

Official title: Acute Cardioversion Versus Wait And See-approach for Symptomatic Atrial Fibrillation in the Emergency Department (ACWAS-trial)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 12-lead ECG

Secondary outcome:

Time to conversion to sinus rhythm (Holter monitor)

Quality of life (SF-36)

One-year follow-up of Major Adverse Cerebrovascular or Cardiovascular Events

Time to first recurrence of Atrial Fibrillation

Total health care and societal costs

Quality of Life (AFEQT)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- ECG with atrial fibrillation at the emergency department

- Heart rate > 70bpm

- Symptoms most probable due to atrial fibrillation

- Duration of symptoms < 24 hours

- > 18 years of age

- Able and willing to sign informed consent

- Able and willing to use MyDiagnostick

Exclusion Criteria:

- Signs of myocardial infarction on ECG

- Hemodynamic instability (systolic blood pressure < 100mm Hg, heart rate > 170 bpm)

- Presence of pre-excitation syndrome

- History of Sick Sinus Syndrome

- History of unexplained syncope

- Acute heart failure

- Deemed unsuitable for participation by attending physician

Locations and Contacts

Elton Dudink, MD, Phone: +31433875119, Email: elton.dudink@mumc.nl

Maastricht University Medical Center, Maastricht, Limburg 6202 AZ, Netherlands; Recruiting
Elton Dudink, MD, Phone: +31433875119, Email: elton.dudink@mumc.nl
Harry Crijns, MD, PhD, Principal Investigator
Elton Dudink, MD, Sub-Investigator
Additional Information

Starting date: October 2014
Last updated: October 6, 2014

Page last updated: August 23, 2015

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