Use of Colchicine to Decrease Atrial Fibrillation Recurrence After Ablation

• Status: Recruiting
• Trial end date: 2024-11-30
• Target enrollment: 0
• Participant gender: All

Summary

Ablation of atrial fibrillation (AFib) has been recommended as a therapeutic option when rhythm maintenance strategy is sought. One of the main objectives of an AFib ablation procedure is electrical isolation of the pulmonary veins, which have been identified as common triggering sites of the arrhythmia. The pathophysiology of AFib is not fully elucidated. Inflammation seems to play an important role in the initiation and maintenance of AFib. Previous studies have shown that inflammatory markers reactivity (eg, C-reactive protein [CRP] complex levels, elevation of white blood cells) are increased in patients who develop AFib. Similarly, recurrence of AFib within the first few weeks after ablation procedure seems to be mediated by an inflammatory process triggered by the ablation per se as implied by increased early CRP levels in AFib ablation patients. On the other hand, AFib can further induce and maintain a cascade of inflammatory events leading to electrical and structural atrial remodeling which leads to higher incidence of Afib development. Many trials have investigated the role of anti-inflammatory agents in preventing post-ablation AFib, using various treatment regimens such as corticosteroid therapy, antiarrhythmic medications like amiodarone, intravenous magnesium, atorvastatin, and colchicine. Previous studies have shown that colchicine can lead to decreased recurrence of post-ablation AFib with a beneficial impact in self-perceived quality of life of the patients. There is limited knowledge regarding the impact of colchicine duration and dosing on post-ablation Afib recurrence and the self-perceived quality of life. The information obtained from this study will ultimately guide future clinical practice to ensure safer outcomes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stony Brook University
• Treatments: Colchicine

Criteria

Inclusion Criteria:

1. Age ≥ 18 years

2. Patients with paroxysmal or persistent atrial fibrillation scheduled to undergo index or repeat Afib ablation procedure (radiofrequency) and or cavotricuspid line ablation, other right/left atrial sites, left at discretion of treating physician.

3. Ability of patient to provide informed consent

Exclusion Criteria:

1. Patients scheduled for ablation of atrial tachycardia/flutter without planned pulmonary vein isolation (i.e. without pulmonary vein isolation).

2. Known hypersensitivity to colchicine/amiodarone/dronedarone

3. Absolute indication for or ongoing treatment with colchicine

4. Clinically overt hepatic disease

5. Serious gastrointestinal disease (severe gastritis or diarrhea)

6. Severe renal disease (eGFR< 30ml/min/1.73m2)

7. Clinically significant blood dyscrasia (e.g., myelodysplasia)

8. Patients already on a strong inhibitor of CYP3A4 or p-gp (clarithromycin, erythromycin, telithromycin, cyclosporine, ketoconazole or itraconazole), precluding the administration of colchicine or amiodarone/dronedarone.

9. Pregnant or breastfeeding women, or women of child-bearing potential who do not use a highly effective form of birth control.