Impact of Colchicine Therapy on Arrhythmia Recurrence After Acute Pericardial Effusion

April 21, 2024 updated by: Yong Seog Oh

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Seo Cho Gu
      • Seoul, Seo Cho Gu, Korea, Republic of, 137-701
        • Seoul St Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No intervention
Experimental: Colchicine
Impact of Colchicine therapy on arrhythmia Recurrence after Acute Pericardial Effusion following Catheter Ablation of Atrial Fibrillation
Drug: Colchicine
Impact of Colchicine therapy on arrhythmia Recurrence after Acute Pericardial Effusion following Catheter Ablation of Atrial Fibrillation
Other Names:
  • Impact of Colchicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence of atrial arrhythimia
Time Frame: 1 year after colchicines administration
Assessment of the recurrence of atrial arrhythimia 1 year after colchicines administration
1 year after colchicines administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence of atrial arrhythimia
Time Frame: 3 year after colchicines administration
Assessment of the recurrence of atrial arrhythimia 3 year after colchicines administration
3 year after colchicines administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yong Seog Oh

Investigators

  • Principal Investigator: Yong Seog Oh, MD, Seoul st. mary's hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

October 1, 2023

Study Registration Dates

First Submitted

October 5, 2014

First Submitted That Met QC Criteria

October 8, 2014

First Posted (Estimated)

October 9, 2014

Study Record Updates

Last Update Posted (Estimated)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 21, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • colchicine

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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