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
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