Post-Ablation Pericarditis Reduction Study (PAPERS)

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

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

248

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Ascension St Vincent Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of care
Usual standard of care post atrial fibrillation ablation.
Experimental: Colchicine
0.6mg colchicine oral twice daily for 7 days.
colchicine 0.6mg oral twice daily for 7 days
Other Names:
  • colcrys
  • mitigare

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Postoperative day 30.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with recurrent Atrial fibrillation
Time Frame: Through study completion, an average of 1 year
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.
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.
Postoperative day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Parin J. Patel, MD, Physician; Board Member, Institutional Review Board; Board Member, Cardiovascular Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2021

Primary Completion (Actual)

January 30, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

May 21, 2021

First Submitted That Met QC Criteria

May 26, 2021

First Posted (Actual)

May 28, 2021

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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