NCT02421900

Brief Summary

The purpose of this study is 1) to characterize T-cell response in patients with atrial fibrillation, and 2) to analyze the changes of T-cell response after radio-frequency catheter ablation of atrial fibrillation. First, immune-phenotyping and cytokine profiling of T cells from patients with atrial fibrillation will performed. Next the difference of T-cell immunity among various type of atrial fibrillation patients will be analyzed. Finally the changes of T-cell response and cytokines after radio-frequency catheter ablation of atrial fibrillation will be assessed.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

4.9 years

First QC Date

April 8, 2015

Last Update Submit

July 15, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • The frequency (%) of specific marker-expressing cells among CD4 or CD8 T-subsets

    * Immunosenescence marker: CD28, CD57 * Activation marker: CD38, HLA-DR * Differentiation marker: CCR7, CD45RA

    1 year

Secondary Outcomes (1)

  • The frequency (%) of cytokine-secreting cells among CD4 or CD8 T-subsets

    1 year

Study Arms (1)

group 1

Atrial fibrillation patients

Other: radio-frequency catheter ablation of atrial fibrillation

Interventions

radio-frequency catheter ablation of atrial fibrillation

group 1

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with atrial fibrillation

You may qualify if:

  • Patients who consent with study
  • patients with age more than19
  • patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation

You may not qualify if:

  • Permanent AF refractory to electrical cardioversion
  • AF with rheumatic valvular disease
  • Patients with left atrial diameter greater than 60mm
  • Patients with age less than 19
  • Patient with malignant tumor and chronic infection disease
  • Patient are given immune inhibitor and steroidal anti-inflammatory drug within 2weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Cardiovascular Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

40cc blood sampling

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Hui-Nam Pak, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2015

First Posted

April 21, 2015

Study Start

April 1, 2015

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

July 17, 2018

Record last verified: 2018-07

Locations