Post-Ablation Pericarditis Reduction Study (PAPERS)

Completed · Phase 2

Conditions studied: Atrial Fibrillation, Catheter Ablation, Pericarditis

In brief

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

Key facts

Study ID

NCT06731595

Run by

St. Vincent Cardiovascular Research Institute

People needed

248

Starts

2021-05-20

Expected to finish

2022-10-01

Last updated by the study team

2024-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All patients >/= 18 undergoing atrial fibrillation ablation

You may not qualify if…

• 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.

Where it is running

• Ascension St Vincent Hospital — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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