Atrial Fibrillation, Recurrence
Conditions
Brief summary
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.
Interventions
p.o. twice daily for 10 days after catheter ablation for atrial fibrillation
DRUGMatching placebo
p.o. twice daily for 10 days after catheter ablation for atrial fibrillation
Sponsors
Population Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Symptomatic atrial fibrillation and planned catheter-guided first or repeat ablation (pulmonary vein isolation) for atrial fibrillation (radiofrequency or cryoablation energy; concomitant ablation of the cavotricuspid isthmus and other lesions left at the discretion of the treating physician) 3. Written informed consent
Exclusion criteria
1. Ablation for left atrial tachycardia or isthmus-dependent atrial flutter only (i.e. without pulmonary vein isolation) 2. Administration of a strong inhibitor of CYP3A4 or p-gp (clarithromycin, erythromycin, telithromycin, cyclosporine, ketoconazole or itraconazole) 3. Known hypersensitivity to colchicine 4. Serious gastrointestinal disease (severe gastritis or diarrhea) 5. Clinically overt hepatic disease 6. Severe renal disease (eGFR\< 30ml/min/1.73m2) 7. Clinically significant blood dyscrasia (e.g., myelodysplasia) 8. Absolute indication for or ongoing treatment with colchicine 9. Pregnant or breastfeeding women, or women of child-bearing potential who do not use a highly effective form of birth control
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average monthly enrollment rate | Through study completion (enrollment phase estimated to last 18 months, total study duration estimated to last 24 months) | Average number of patients enrolled per month |
| Compliance with study treatment | From randomization until 10 days after catheter ablation | Number of provided capsules taken (measured as a proportion of 20 capsules) |
| Rate of complete follow-up at 6 months | From inception until completion of the study | This will describe the rate of patients for whom the 6-month follow visit can be completed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of atrial fibrillation between 10-15 weeks after catheter ablation | Between week 10 and 15 after catheter ablation for atrial fibrillation | 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 |
| Rate of non-infectious diarrhea | From randomization until 10 days after catheter ablation | Three or more loose stools per day, in absence of an overt infectious cause |
| Rate of all-cause mortality | Through study completion (estimated to be up to 24 months) | This will describe the rate of all-cause mortality during the course of the study. |
| Rate of patients with composite clinical endpoint | Through study completion (estimated to be up to 24 months) | 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 |
| Rate of signs and symptoms of pericarditis | From randomization until 10 days after catheter ablation | Evidence of new or worsening pericardial effusion on echocardiogram, friction rub on auscultation or pleuritic chest pain |
| Recurrence of atrial fibrillation within the first 2 weeks after catheter ablation | From randomization until 2 weeks after catheter ablation for atrial fibrillation | 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 |
Countries
Canada
Outcome results
None listed