Back to resultsImpact 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
About this trial
This is an interventional treatment trial for Pericardial Effusion focused on measuring Pericardial Effusion, Colchicine, arrhythmia Recurrence, pericardiocentesis
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
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
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
Learn more about this trial
Impact of Colchicine Therapy on Arrhythmia Recurrence After Acute Pericardial Effusion
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