Post-Ablation Pericarditis Reduction Study (PAPERS)

Phase 2

Completed

• Conditions: Atrial Fibrillation; Catheter Ablation; Pericarditis
• Interventions: Drug: Colchicine

• Registration Number: NCT06731595
• Lead Sponsor: St. Vincent Cardiovascular Research Institute

Brief 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

Detailed Description

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.

Study Timeline

• Study Start: 2021-05-20
• Primary Completion: 2022-01-30
• Study Completion: 2022-10-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-12
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colchicine	Colchicine	0.6mg colchicine oral twice daily for 7 days.

Primary Outcome Measures

Name	Time	Method
Proportion of patients with Pericarditis	Postoperative day 30.	Clinical pericarditis ascertained by comprehensive chart review and a follow up phone call using a survey instrument.

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with recurrent Atrial fibrillation	Through study completion, an average of 1 year	Recurrence of atrial fibrillation post ablation
Median rating of patient satisfaction on a Likert scale, comparing the study group and standard of care group.	Postoperative day 14	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.

Trial Locations

Locations (1)

Ascension St Vincent Hospital; 🇺🇸 Indianapolis, Indiana, United States