Impact of Colchicine Therapy on Arrhythmia Recurrence After Acute Pericardial Effusion

Phase 4

Completed

• Conditions: Pericardial Effusion
• Interventions: Drug: Colchicine

• Registration Number: NCT02260206
• Lead Sponsor: Yong Seog Oh

Brief Summary

The effects colchicine administration for acute pericardial effusion after radiofrequency catheter ablation (RFCA) of atrial fibrillation on the recurrences of arrhythmia.

Detailed Description

RFCA was started as a rhythm control of atrial fibrillation about 10 years before and the superiority of RFCA to medical treatment has been continuously reporting, so RFCA is globally performed nowadays. Acute pericardial effusion could occur during RFCA as complication, that might be developed to cardiac tamponade needed immediate pericardiocentesis. The inflammation developed after pericardiocentesis might be associated with the recurrences of atrial fibrillation, it could be presumed by the frequent occurrence of atrial fibrillation after open-heart surgery. The inflammation can be suppressed by administration of colchicine and the effects of colchicine have been proven to decrease the development of atrial fibrillation.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-10-05
• Study First Submitted QC: 2014-10-08
• Study First Posted: 2014-10-09
• Primary Completion: 2019-09
• Study Completion: 2023-10
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-21
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients needed to pericardiocentesis during RFCA for paroxysmal or persistent atrial fibrillation.

Exclusion Criteria

• Hypersensitivity on Colchicine
• The existence of intra-cardiac thrombus on trans-esophageal echocardiography
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colchicine	Colchicine	Impact of Colchicine therapy on arrhythmia Recurrence after Acute Pericardial Effusion following Catheter Ablation of Atrial Fibrillation

Primary Outcome Measures

Name	Time	Method
recurrence of atrial arrhythimia	1 year after colchicines administration	Assessment of the recurrence of atrial arrhythimia 1 year after colchicines administration

Secondary Outcome Measures

Name	Time	Method
recurrence of atrial arrhythimia	3 year after colchicines administration	Assessment of the recurrence of atrial arrhythimia 3 year after colchicines administration

Trial Locations

Locations (1)

Seoul St Mary's Hospital; 🇰🇷 Seoul, Seo Cho Gu, Korea, Republic of