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| ID | Type | Description | Link |
|---|---|---|---|
| 837002524 | Other Grant/Funding Number | ZonMw |
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | Active Comparator | Pharmacological cardioversion and/or electrical cardioversion |
|
| Wait-and-see Approach | Experimental | Rate control drugs only (metoprolol, verapamil or digoxin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacological cardioversion - Flecainide | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 12-lead ECG | Presence of sinus rhythm on ECG | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to conversion to sinus rhythm (Holter monitor) | Intervention group only | 48 hours |
| Quality of life (SF-36) | Baseline, 4 weeks, 6 months, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harry J Crijns, MD, PhD | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VU University Medical Center | Amsterdam | Netherlands | ||||
| Amphia Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27979041 | Background | 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. | |
| 36322782 |
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| Electrical cardioversion |
| Procedure |
|
| Metoprolol | Drug |
|
|
| Verapamil | Drug |
|
|
| Digoxin | Drug |
|
|
| Pharmacological cardioversion - Amiodarone | Drug |
|
|
| One-year follow-up of Major Adverse Cerebrovascular or Cardiovascular Events | One year |
| Time to first recurrence of Atrial Fibrillation | Monitoring through handheld device | 1 month |
| Total health care and societal costs | 1 year |
| Quality of Life (AFEQT) | Baseline, 4 weeks, 6 months, 12 months |
| 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 | Netherlands |
| Derived |
| van der Velden RMJ, Pluymaekers NAHA, Dudink EAMP, Luermans JGLM, Meeder JG, Heesen WF, Lenderink T, Widdershoven JWMG, Bucx JJJ, Rienstra M, Kamp O, van Opstal JM, Kirchhof CJHJ, van Dijk VF, Swart HP, Alings M, Van Gelder IC, Crijns HJGM, Linz D. Mobile health adherence for the detection of recurrent recent-onset atrial fibrillation. Heart. 2022 Dec 13;109(1):26-33. doi: 10.1136/heartjnl-2022-321346. |
| 30883054 | Derived | Pluymaekers NAHA, Dudink EAMP, Luermans JGLM, Meeder JG, Lenderink T, Widdershoven J, Bucx JJJ, Rienstra M, Kamp O, Van Opstal JM, Alings M, Oomen A, Kirchhof CJ, Van Dijk VF, Ramanna H, Liem A, Dekker LR, Essers BAB, Tijssen JGP, Van Gelder IC, Crijns HJGM; RACE 7 ACWAS Investigators. Early or Delayed Cardioversion in Recent-Onset Atrial Fibrillation. N Engl J Med. 2019 Apr 18;380(16):1499-1508. doi: 10.1056/NEJMoa1900353. Epub 2019 Mar 18. |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005424 | Flecainide |
| D004554 | Electric Countershock |
| D008790 | Metoprolol |
| D014700 | Verapamil |
| D004077 | Digoxin |
| D000638 | Amiodarone |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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