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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02260206
Other study ID # colchicine
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 2014
Est. completion date October 2023

Study information

Verified date April 2024
Source Seoul St. Mary's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date October 2023
Est. primary completion date September 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Colchicine
Impact of Colchicine therapy on arrhythmia Recurrence after Acute Pericardial Effusion following Catheter Ablation of Atrial Fibrillation

Locations

Country Name City State
Korea, Republic of Seoul St Mary's Hospital Seoul Seo Cho Gu

Sponsors (1)

Lead Sponsor Collaborator
Yong Seog Oh

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary recurrence of atrial arrhythimia Assessment of the recurrence of atrial arrhythimia 1 year after colchicines administration 1 year after colchicines administration
Secondary recurrence of atrial arrhythimia Assessment of the recurrence of atrial arrhythimia 3 year after colchicines administration 3 year after colchicines administration
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