Post-Ablation Pericarditis Reduction Study

Study Overview
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Brief Summary
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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 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). Identify potential differences in patients undergoing PVI only versus PVI + additional ablation Identify whether patients on who are already on anti-inflammatories such as ASA or statins have a lower incidence than those without Determine if an empiric treatment strategy with colchicine (for 7 days post ablation) reduces the incidence of post-operative AF

Detailed Description
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This study will be a prospective, randomized controlled study of 248 patients presenting to the electrophysiology lab at Ascension St. Vincent (Indianapolis, IN) and Ascension Sacred Heart (Pensacola, FL) for atrial fibrillation ablation. Cases will be randomized in sequential order. The control arm will undergo standard of care, whereas the study arm will undergo treatment with colchicine 0.6mg PO BID for 7 days following ablation. Study variables will consist of Patient demographics o age, gender, comorbidities (HTN, HLD, DM-2, COPD, tobacco use, OSA, CKD, weight in kg, BMI, LVEF, autoimmune inflammatory condition such as RA), type of AF (paroxysmal, persistent, etc.) Medical therapy characteristics o anticoagulation choice, statin present, aspirin present, discontinuation of colchicine due to gastrointestinal distress Procedural characteristics o length of procedure, initial vs redo procedure, PVI only versus PVI + additional lines, total RF application time, HPSD vs MPMD approach, #RF applications, Power, Contact force, Impedance Rates of acute post-operative pericarditis will be compared between the two groups. Subjects will be called by study personnel within 7-14 days to identify any post-ablation symptoms. If a patient develops pericarditis, standard anti-inflammatory therapy will be initiated in those patients regardless of study arm. The primary outcome will be the development of post-AF ablation pericarditis within 30 days of ablation. This will be ascertained by comprehensive chart review and at the routine post-ablation follow up visit; additionally, there will be a standard telephone survey administered 7-14d after ablation (see instrument). Secondary outcomes will include symptoms, incidence of post-ablation AF recurrence, patient satisfaction using a Likert scale, and other clinical variables.

Official Title
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Post-Ablation Pericarditis Reduction Study

Conditions
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Atrial Fibrillation, Catheter Ablation, Pericarditis

Intervention / Treatment
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* Drug: Colchicine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of care<br>Usual standard of care post atrial fibrillation ablation. | |
| Experimental: Colchicine<br>0.6mg colchicine oral twice daily for 7 days. | Drug: Colchicine<br>* colchicine 0.6mg oral twice daily for 7 days<br>* Other names: mitigare;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with Pericarditis | Clinical pericarditis ascertained by comprehensive chart review and a follow up phone call using a survey instrument. | Postoperative day 30. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with recurrent Atrial fibrillation | Recurrence of atrial fibrillation post ablation | Through study completion, an average of 1 year | 
| Median rating of patient satisfaction on a Likert scale, comparing the study group and standard of care group. | Patient satisfaction with ablation and post ablation care, measured on a Likert scale (min 1 and max 5, with 1 being best and 5 being worst) and derived from a telephone survey. | Postoperative day 14 |