Post-Ablation Pericarditis Reduction Study

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

There has not been a prospective, randomized controlled trial of colchicine to reduce post-AF ablation pericarditis in an era of newer AF ablation techniques. The hypothesis is that an empiric pre and post AF ablation treatment protocol with colchicine may reduce the incidence and symptom severity of post-AF ablation related pericarditis. Thus, the goal of this study is to

1. Identify the incidence of post-AF ablation related pericarditis in patients undergoing ablation via high power, short duration strategy (shorter total RF time, but increased stability due to steerable catheters and possible difference from resistive vs conductive heating).

2. Identify potential differences in patients undergoing PVI only versus PVI + additional ablation

3. Identify whether patients on who are already on anti-inflammatories such as ASA or statins have a lower incidence than those without

4. Determine if an empiric treatment strategy with colchicine (for 7 days post ablation) reduces the incidence of post-operative AF

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: St. Vincent Cardiovascular Research Institute
• Treatments: Colchicine

Criteria

Inclusion criteria:

• All patients >/= 18 undergoing atrial fibrillation ablation

Exclusion Criteria:

• Patients unable to receive or tolerate colchicine

• Pregnant or lactating women

• Concomitant use of drugs interacting with colchicine (including: cyclosporin, ranolazine, tacrolimus, clarithromycin, indinavir, itraconazole, ketoconazole, nefazadone, ritonavir, saquinavir, suboxone, telithromycin, erythromycin, fluconazole, verapamil, diltiazem, or more than 1 glass grapefruit juice daily)

• Severe renal impairment (CrCl < 30 mL/min)

• Severe hepatic impairment (ALT/AST greater than 5x ULN or clinical cirrhosis)

• Ongoing current use of colchicine.