Impact of Colchicine Therapy on Arrhythmia Recurrence After Acute Pericardial Effusion

NCT ID: NCT02260206

Last Updated: 2024-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2023-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pericardial Effusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

None (Open label)
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Colchicine

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

Group Type EXPERIMENTAL

Colchicine

Intervention Type DRUG

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

No intervention

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Colchicine

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

Intervention Type DRUG

Other Intervention Names

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Impact of Colchicine

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yong Seog Oh

OTHER

Sponsor Role lead

Responsible Party

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Yong Seog Oh

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yong Seog Oh, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Locations

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Seoul St Mary's Hospital

Seoul, Seo Cho Gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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colchicine

Identifier Type: -

Identifier Source: org_study_id

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