NCT02260206

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2014

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

5.2 years

First QC Date

October 5, 2014

Last Update Submit

April 21, 2024

Conditions

Pericardial Effusion

Keywords

Pericardial EffusionColchicinearrhythmia Recurrencepericardiocentesis

Outcome Measures

Primary Outcomes (1)

  • recurrence of atrial arrhythimia

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

    1 year after colchicines administration

Secondary Outcomes (1)

  • recurrence of atrial arrhythimia

    3 year after colchicines administration

Study Arms (2)

Colchicine

EXPERIMENTAL

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

Drug: Colchicine

No intervention

NO INTERVENTION

No intervention

Interventions

ColchicineDRUG

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

Also known as: Impact of Colchicine
Colchicine

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients needed to pericardiocentesis during RFCA for paroxysmal or persistent atrial fibrillation.

You may not qualify if:

  • Hypersensitivity on Colchicine
  • The existence of intra-cardiac thrombus on trans-esophageal echocardiography
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St Mary's Hospital

Seoul, Seo Cho Gu, 137-701, South Korea

Location

MeSH Terms

Conditions

Pericardial Effusion

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Study Officials

  • Yong Seog Oh, MD

    Seoul St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: None (Open label)
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 5, 2014

First Posted

October 9, 2014

Study Start

July 1, 2014

Primary Completion

September 1, 2019

Study Completion

October 1, 2023

Last Updated

April 23, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)