Post-Ablation Pericarditis Reduction Study (PAPERS)
Primary Purpose
Atrial Fibrillation, Catheter Ablation, Pericarditis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Colchicine
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation
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.
Sites / Locations
- Ascension St Vincent Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of care
Colchicine
Arm Description
Usual standard of care post atrial fibrillation ablation.
0.6mg colchicine oral twice daily for 7 days.
Outcomes
Primary Outcome Measures
Proportion of patients with Pericarditis
Clinical pericarditis ascertained by comprehensive chart review and a follow up phone call using a survey instrument.
Secondary Outcome Measures
Proportion of patients with recurrent Atrial fibrillation
Recurrence of atrial fibrillation post ablation
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.
Full Information
NCT ID
NCT04906720
First Posted
May 21, 2021
Last Updated
November 7, 2022
Sponsor
St. Vincent Cardiovascular Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04906720
Brief Title
Post-Ablation Pericarditis Reduction Study
Acronym
PAPERS
Official Title
Post-Ablation Pericarditis Reduction Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
January 30, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Vincent Cardiovascular Research Institute
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Catheter Ablation, Pericarditis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
248 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Usual standard of care post atrial fibrillation ablation.
Arm Title
Colchicine
Arm Type
Experimental
Arm Description
0.6mg colchicine oral twice daily for 7 days.
Intervention Type
Drug
Intervention Name(s)
Colchicine
Other Intervention Name(s)
colcrys, mitigare
Intervention Description
colchicine 0.6mg oral twice daily for 7 days
Primary Outcome Measure Information:
Title
Proportion of patients with Pericarditis
Description
Clinical pericarditis ascertained by comprehensive chart review and a follow up phone call using a survey instrument.
Time Frame
Postoperative day 30.
Secondary Outcome Measure Information:
Title
Proportion of patients with recurrent Atrial fibrillation
Description
Recurrence of atrial fibrillation post ablation
Time Frame
Through study completion, an average of 1 year
Title
Median rating of patient satisfaction on a Likert scale, comparing the study group and standard of care group.
Description
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.
Time Frame
Postoperative day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parin J. Patel, MD
Organizational Affiliation
Physician; Board Member, Institutional Review Board; Board Member, Cardiovascular Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ascension St Vincent Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26228647
Citation
Leung YY, Yao Hui LL, Kraus VB. Colchicine--Update on mechanisms of action and therapeutic uses. Semin Arthritis Rheum. 2015 Dec;45(3):341-50. doi: 10.1016/j.semarthrit.2015.06.013. Epub 2015 Jun 26.
Results Reference
result
PubMed Identifier
16186437
Citation
Imazio M, Bobbio M, Cecchi E, Demarie D, Demichelis B, Pomari F, Moratti M, Gaschino G, Giammaria M, Ghisio A, Belli R, Trinchero R. Colchicine in addition to conventional therapy for acute pericarditis: results of the COlchicine for acute PEricarditis (COPE) trial. Circulation. 2005 Sep 27;112(13):2012-6. doi: 10.1161/CIRCULATIONAHA.105.542738.
Results Reference
result
PubMed Identifier
25172965
Citation
Imazio M, Brucato A, Ferrazzi P, Pullara A, Adler Y, Barosi A, Caforio AL, Cemin R, Chirillo F, Comoglio C, Cugola D, Cumetti D, Dyrda O, Ferrua S, Finkelstein Y, Flocco R, Gandino A, Hoit B, Innocente F, Maestroni S, Musumeci F, Oh J, Pergolini A, Polizzi V, Ristic A, Simon C, Spodick DH, Tarzia V, Trimboli S, Valenti A, Belli R, Gaita F; COPPS-2 Investigators. Colchicine for prevention of postpericardiotomy syndrome and postoperative atrial fibrillation: the COPPS-2 randomized clinical trial. JAMA. 2014 Sep 10;312(10):1016-23. doi: 10.1001/jama.2014.11026.
Results Reference
result
PubMed Identifier
32720823
Citation
Tabbalat RA, Alhaddad I, Hammoudeh A, Khader YS, Khalaf HA, Obaidat M, Barakat J. Effect of Low-dose ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Low Dose Trial. J Int Med Res. 2020 Jul;48(7):300060520939832. doi: 10.1177/0300060520939832.
Results Reference
result
PubMed Identifier
23040570
Citation
Deftereos S, Giannopoulos G, Kossyvakis C, Efremidis M, Panagopoulou V, Kaoukis A, Raisakis K, Bouras G, Angelidis C, Theodorakis A, Driva M, Doudoumis K, Pyrgakis V, Stefanadis C. Colchicine for prevention of early atrial fibrillation recurrence after pulmonary vein isolation: a randomized controlled study. J Am Coll Cardiol. 2012 Oct 30;60(18):1790-6. doi: 10.1016/j.jacc.2012.07.031. Epub 2012 Oct 3.
Results Reference
result
PubMed Identifier
24508207
Citation
Deftereos S, Giannopoulos G, Efremidis M, Kossyvakis C, Katsivas A, Panagopoulou V, Papadimitriou C, Karageorgiou S, Doudoumis K, Raisakis K, Kaoukis A, Alexopoulos D, Manolis AS, Stefanadis C, Cleman MW. Colchicine for prevention of atrial fibrillation recurrence after pulmonary vein isolation: mid-term efficacy and effect on quality of life. Heart Rhythm. 2014 Apr;11(4):620-8. doi: 10.1016/j.hrthm.2014.02.002. Epub 2014 Feb 4.
Results Reference
result
PubMed Identifier
32553209
Citation
Deyell MW, Leather RA, Macle L, Forman J, Khairy P, Zhang R, Ding L, Chakrabarti S, Yeung-Lai-Wah JA, Lane C, Novak PG, Sterns LD, Bennett MT, Laksman ZW, Sikkel MB, Andrade JG. Efficacy and Safety of Same-Day Discharge for Atrial Fibrillation Ablation. JACC Clin Electrophysiol. 2020 Jun;6(6):609-619. doi: 10.1016/j.jacep.2020.02.009. Epub 2020 Apr 29.
Results Reference
result
PubMed Identifier
32081221
Citation
Ahmed AS, Clark BA, Joshi SA, Nair GV, Olson JA, Padanilam BJ, Patel PJ. Avoiding Bladder Catheters During Atrial Fibrillation Ablation. JACC Clin Electrophysiol. 2020 Feb;6(2):185-190. doi: 10.1016/j.jacep.2019.10.003. Epub 2019 Nov 27.
Results Reference
result
PubMed Identifier
33270311
Citation
Gilge JL, Ahmed A, Clark BA, Slaten A, Devathu R, Olson JA, Padanilam BJ, Nair GV, Joshi SA, Ravichandran AK, Patel PJ. Left atrial hypertension and the risk of early incident heart failure after atrial fibrillation ablation. J Cardiovasc Electrophysiol. 2021 Feb;32(2):325-332. doi: 10.1111/jce.14829. Epub 2020 Dec 14.
Results Reference
result
Learn more about this trial
Post-Ablation Pericarditis Reduction Study
We'll reach out to this number within 24 hrs