Atrial Fibrillation Clinical Trial
— RACE 7 ACWASOfficial title:
Acute Cardioversion Versus Wait And See-approach for Symptomatic Atrial Fibrillation in the Emergency Department (RACE 7 ACWAS-trial)
Verified date | January 2020 |
Source | Maastricht University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 437 |
Est. completion date | December 2019 |
Est. primary completion date | November 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - ECG with atrial fibrillation at the emergency department - Heart rate > 70bpm - Symptoms most probable due to atrial fibrillation - Duration of symptoms < 36 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 - History of persistent AF (episode of AF lasting more than 48 hours) - Acute heart failure - Currently enrolled in another clinical trial - Deemed unsuitable for participation by attending physician |
Country | Name | City | State |
---|---|---|---|
Netherlands | VU University Medical Center | Amsterdam | |
Netherlands | Amphia Hospital | Breda | |
Netherlands | Catharina Ziekenhuis | Eindhoven | |
Netherlands | Medisch Spectrum Twente | Enschede | |
Netherlands | University Medical Center Groningen | Groningen | |
Netherlands | Zuyderland Medical Center | Heerlen | |
Netherlands | Alrijne Hospital | Leiderdorp | |
Netherlands | Maastricht University Medical Center | Maastricht | |
Netherlands | St. Antonius Hospital | Nieuwegein | |
Netherlands | Franciscus Gasthuis | Rotterdam | |
Netherlands | Antonius Ziekenhuis | Sneek | |
Netherlands | HagaZiekenhuis | The Hague | |
Netherlands | St. Elisabeth - TweeSteden Hospital | Tilburg | |
Netherlands | Diakonessenhuis | Utrecht | |
Netherlands | VieCuri Medical Center | Venlo |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center | ZonMw: The Netherlands Organisation for Health Research and Development |
Netherlands,
Dudink E, Essers B, Holvoet W, Weijs B, Luermans J, Ramanna H, Liem A, van Opstal J, Dekker L, van Dijk V, Lenderink T, Kamp O, Kulker L, Rienstra M, Kietselaer B, Alings M, Widdershoven J, Meeder J, Prins M, van Gelder I, Crijns H. Acute cardioversion vs a wait-and-see approach for recent-onset symptomatic atrial fibrillation in the emergency department: Rationale and design of the randomized ACWAS trial. Am Heart J. 2017 Jan;183:49-53. doi: 10.1016/j.ahj.2016.09.009. Epub 2016 Oct 2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 12-lead ECG | Presence of sinus rhythm on ECG | 4 weeks | |
Secondary | Time to conversion to sinus rhythm (Holter monitor) | Intervention group only | 48 hours | |
Secondary | Quality of life (SF-36) | Baseline, 4 weeks, 6 months, 12 months | ||
Secondary | One-year follow-up of Major Adverse Cerebrovascular or Cardiovascular Events | One year | ||
Secondary | Time to first recurrence of Atrial Fibrillation | Monitoring through handheld device | 1 month | |
Secondary | Total health care and societal costs | 1 year | ||
Secondary | Quality of Life (AFEQT) | Baseline, 4 weeks, 6 months, 12 months |
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