Analysis of the Role of T-cell Response in Patients With Atrial Fibrillation for Clinical Application

Atrial Fibrillation Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02421900
• Other study ID #: 4-2015-0090
• Status: Recruiting
• Start date: April 1, 2015
• Est. completion date: March 2020

Study information

• Verified date: July 2018
• Source: Yonsei University
• Contact: Hui-Nam Pak, MD, PhD
• Phone: 82-2-2228-8459
• Email: hnpak[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients who do not agree with study inclusion

• 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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• radio-frequency catheter ablation of atrial fibrillation
radio-frequency catheter ablation of atrial fibrillation

Locations

Country	Name	City	State
Korea, Republic of	Severance Cardiovascular Hospital, Yonsei University Health System	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The frequency (%) of cytokine-secreting cells among CD4 or CD8 T-subsets	Proinflammatory cytokine: IFN-gamma, TNF-alpha; Cytotoxic molecule: granzyme B, perforin	1 year