Clinical trial NCT04906720: Post-Ablation Pericarditis Reduction Study
Official title: Post-Ablation Pericarditis Reduction Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Fibrillation
Catheter Ablation
Pericarditis
Lead sponsor: St. Vincent Cardiovascular Research Institute
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Proportion of patients with Pericarditis
timeFrame: Postoperative day 30.
Secondary outcomes:
measure: Proportion of patients with recurrent Atrial fibrillation
timeFrame: Through study completion, an average of 1 year
measure: Median rating of patient satisfaction on a Likert scale, comparing the study group and standard of care group.
timeFrame: Postoperative day 14
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Ascension St Vincent Hospital
state: Indiana
Study officials:
affiliation: Physician; Board Member, Institutional Review Board; Board Member, Cardiovascular Research Institute
name: Parin J. Patel, MD
role: PRINCIPAL_INVESTIGATOR
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