Post-Ablation Pericarditis Reduction Study

Atrial Fibrillation Clinical Trial

— PAPERS  

Official title:

Post-Ablation Pericarditis Reduction Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04906720
• Other study ID #: R20200174
• Status: Completed
• Phase: Phase 2
• Start date: May 20, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: November 2022
• Source: St. Vincent Cardiovascular Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: October 1, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Catheter Ablation
• Pericarditis

Intervention

Drug:
• Colchicine
colchicine 0.6mg oral twice daily for 7 days

Locations

Country	Name	City	State
United States	Ascension St Vincent Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
St. Vincent Cardiovascular Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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 r — View 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 pu — View 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. J — View 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. — View 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 (C — View 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, Polizz — View 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. Review. — View 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. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with Pericarditis	Clinical pericarditis ascertained by comprehensive chart review and a follow up phone call using a survey instrument.	Postoperative day 30.
Secondary	Proportion of patients with recurrent Atrial fibrillation	Recurrence of atrial fibrillation post ablation	Through study completion, an average of 1 year
Secondary	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.	Postoperative day 14

External Links

•   Darmoch F, Al-Khadra Y, Soud M, et al. NATIONAL TRENDS OF ACUTE PERICARDITIS AND PERICARDIAL EFFUSION POST ATRIAL FIBRILLATION ABLATION. J Am Coll Cardiol. 2019;73(9):550.
•   Gupta S, Desai R, Kumar A, et al. TRENDS IN ACUTE POST-ABLATION PERICARDITIS AND RELATED HEALTHCARE BURDEN IN SYMPTOMATIC ATRIAL FIBRILLATION HOSPITALIZATIONS: INSIGHTS FROM THE NATIONAL INPATIENT SAMPLE (2009-2014). J Am Coll Cardiol. 2019;73(9):442.