Impact of Colchicine Therapy on Arrhythmia Recurrence After Acute Pericardial Effusion

Pericardial Effusion Clinical Trial

Official title:

Impact of Colchicine Therapy on Arrhythmia Recurrence After Acute Pericardial Effusion Following Catheter Ablation of Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02260206
• Other study ID #: colchicine
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Pericardial Effusion
• Recurrence

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