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Impact of Colchicine Therapy on Arrhythmia Recurrence After Acute Pericardial Effusion

Primary Purpose

Pericardial Effusion

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Colchicine
Sponsored by
Yong Seog Oh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pericardial Effusion focused on measuring Pericardial Effusion, Colchicine, arrhythmia Recurrence, pericardiocentesis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul St Mary's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Colchicine

No intervention

Arm Description

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

No intervention

Outcomes

Primary Outcome Measures

recurrence of atrial arrhythimia
Assessment of the recurrence of atrial arrhythimia 1 year after colchicines administration

Secondary Outcome Measures

recurrence of atrial arrhythimia
Assessment of the recurrence of atrial arrhythimia 3 year after colchicines administration

Full Information

First Posted
October 5, 2014
Last Updated
April 4, 2019
Sponsor
Yong Seog Oh
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1. Study Identification

Unique Protocol Identification Number
NCT02260206
Brief Title
Impact of Colchicine Therapy on Arrhythmia Recurrence After Acute Pericardial Effusion
Official Title
Impact of Colchicine Therapy on Arrhythmia Recurrence After Acute Pericardial Effusion Following Catheter Ablation of Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yong Seog Oh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pericardial Effusion
Keywords
Pericardial Effusion, Colchicine, arrhythmia Recurrence, pericardiocentesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Colchicine
Arm Type
Experimental
Arm Description
Impact of Colchicine therapy on arrhythmia Recurrence after Acute Pericardial Effusion following Catheter Ablation of Atrial Fibrillation
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
Colchicine
Other Intervention Name(s)
Impact of Colchicine
Intervention Description
Impact of Colchicine therapy on arrhythmia Recurrence after Acute Pericardial Effusion following Catheter Ablation of Atrial Fibrillation
Primary Outcome Measure Information:
Title
recurrence of atrial arrhythimia
Description
Assessment of the recurrence of atrial arrhythimia 1 year after colchicines administration
Time Frame
1 year after colchicines administration
Secondary Outcome Measure Information:
Title
recurrence of atrial arrhythimia
Description
Assessment of the recurrence of atrial arrhythimia 3 year after colchicines administration
Time Frame
3 year after colchicines administration

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sung Hwan Kim, professor
Phone
82-2-2258-1141
Email
sunghwan@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Seog Oh, MD
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St Mary's Hospital
City
Seoul
State/Province
Seo Cho Gu
ZIP/Postal Code
137-701
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
In Ae Jung, coordinator

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Colchicine Therapy on Arrhythmia Recurrence After Acute Pericardial Effusion

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