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Recurrence is a common problem after catheter ablation for atrial fibrillation, affecting at least one out of three patients. Inflammation due to the procedure may contribute to pulmonary vein reconnection and, thus, failure of catheter ablation.
This pilot study will assess whether a randomized, placebo-controlled, double-blind trial investigating a 10-day treatment with colchicine, a potent anti-inflammatory drug, to improve patient relevant outcomes after catheter ablation for atrial fibrillation is feasible.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Colchicine 0.6 mg p.o. twice daily for 10 days after catheter ablation for atrial fibrillation |
|
| Control | Placebo Comparator | Matching placebo p.o. twice daily for 10 days after catheter ablation for atrial fibrillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine 0.6 mg | Drug | p.o. twice daily for 10 days after catheter ablation for atrial fibrillation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average monthly enrollment rate | Average number of patients enrolled per month | Through study completion (enrollment phase estimated to last 18 months, total study duration estimated to last 24 months) |
| Compliance with study treatment | Number of provided capsules taken (measured as a proportion of 20 capsules) | From randomization until 10 days after catheter ablation |
| Rate of complete follow-up at 6 months | This will describe the rate of patients for whom the 6-month follow visit can be completed | From inception until completion of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of non-infectious diarrhea | Three or more loose stools per day, in absence of an overt infectious cause | From randomization until 10 days after catheter ablation |
| Rate of signs and symptoms of pericarditis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Benz, MD | Population Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Health Sciences Corporation - Hamilton General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38126206 | Result | Benz AP, Amit G, Connolly SJ, Singh J, Acosta-Velez JG, Conen D, Deif B, Divakaramenon S, McIntyre WF, Mtwesi V, Roberts JD, Wong JA, Zhao R, Healey JS; IMPROVE-PVI Investigators. Colchicine to Prevent Atrial Fibrillation Recurrence After Catheter Ablation: A Randomized, Placebo-Controlled Trial. Circ Arrhythm Electrophysiol. 2024 Jan;17(1):e01238. doi: 10.1161/CIRCEP.123.012387. Epub 2023 Dec 21. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Matching placebo | Drug | p.o. twice daily for 10 days after catheter ablation for atrial fibrillation |
|
Evidence of new or worsening pericardial effusion on echocardiogram, friction rub on auscultation or pleuritic chest pain
| From randomization until 10 days after catheter ablation |
| Recurrence of atrial fibrillation within the first 2 weeks after catheter ablation | Any episode of atrial fibrillation lasting > 30 seconds within 2 weeks after catheter ablation for atrial fibrillation. Atrial flutter or other forms of atrial tachycardia are included in this definition | From randomization until 2 weeks after catheter ablation for atrial fibrillation |
| Recurrence of atrial fibrillation between 10-15 weeks after catheter ablation | Any episode of atrial fibrillation lasting > 30 seconds between 10-15 weeks after catheter ablation for atrial fibrillation. Atrial flutter or other forms of atrial tachycardia are included in this definition | Between week 10 and 15 after catheter ablation for atrial fibrillation |
| Rate of patients with composite clinical endpoint | Emergency department visit: Patient seeking medical attention at any emergency department or Hospitalization for cardiovascular cause: Minimum of one overnight stay in hospital for cardiovascular reason (e.g. recurrence of atrial fibrillation, atrial flutter, atrial tachycardia; hypotension; hypertension; heart failure; myocardial infarction; bleeding, stroke etc.) or Cardioversion: Pharmacological or electrical attempt of or restoring sinus rhythm, irrespective of success of the procedure or Repeat ablation for atrial fibrillation, atrial flutter or left atrial tachycardia: Catheter-guided pulmonary vein isolation, or ablation of cavotricuspid isthmus, or ablation for other left atrial tachycardia (e.g. macro-reentrant tachycardia, focal tachycardia) after the index procedure | Through study completion (estimated to be up to 24 months) |
| Rate of all-cause mortality | This will describe the rate of all-cause mortality during the course of the study. | Through study completion (estimated to be up to 24 months) |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |