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Completed

NCT Number: NCT04906720

Post-Ablation Pericarditis Reduction Study

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ascension St Vincent Hospital

Indianapolis, Indiana, 46260, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Colchicine

Drug

colchicine 0.6mg oral twice daily for 7 days

Other names: colcrys, mitigare

Primary outcomes

  1. Proportion of patients with Pericarditis

    Time frame: Postoperative day 30.

    Clinical pericarditis ascertained by comprehensive chart review and a follow up phone call using a survey instrument.

Secondary outcomes

  1. Proportion of patients with recurrent Atrial fibrillation

    Time frame: Through study completion, an average of 1 year

    Recurrence of atrial fibrillation post ablation

  2. Median rating of patient satisfaction on a Likert scale, comparing the study group and standard of care group.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

St. Vincent Cardiovascular Research Institute

Other

Registry information

Acronym: PAPERS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 28, 2021
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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