Reverse Prediction of Ion Channel Remodeling in Patients With Atrial Fibrillation Utilizing Monophasic Action Potential and Mathematical Modeling

Atrial Fibrillation Clinical Trial

Official title:

Reverse Prediction of Ion Channel Remodeling in Patients With Atrial Fibrillation Utilizing Monophasic Action Potential and Mathematical Modeling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02414815
• Other study ID #: 4-2014-0685
• Status: Completed
• Phase: N/A
• Start date: August 28, 2015
• Est. completion date: March 2, 2017

Study information

• Verified date: February 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Atrial fibrillation(AF) is the most common sustained arrhythmia in humans. The loss of rate-dependent action potential duration(APD) adaptation is one of the characteristics of atrial fibrillation, but detailed understanding of mechanism is limited. Thus, we propose to utilize the monophasic action potential recording data from human patients in three groups, control, paroxysmal and persistent atrial fibrillation, and apply reverse engineering method to quantify the extent of electrical remodeling of ionic channel parameters using a mathematical model of atrial cell. Our approach will be useful in developing drug targets for ion channels in atrial fibrillation patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2, 2017
• Est. primary completion date: March 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients agreement of consent

• AF patient age 19-75

• Patients who undergoing catheter ablation of atrial fibrillation or supraventricular tachycardia

• Patient agreement of consent who admission for catheter ablation

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 or more 75

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Monophasic action potential(MAP) catheter
After ordinary procedure for electrophysiologic study or catheter ablation, the investigators will replace conventional catheter to monophasic action potential (MAP) recording catheter through right femoral sheath. MAP recording catheter is introduced to endocardial surface of atrium, and we record atrial MAP at variable pacing cycle lengths: steady state cycle lengths of 600, 400, 300, 240, 220, 240, 260, 300, 400 and 600 ms. At each cycle length, pacing was applied for 20 sec. It takes less than 5 min to acquire MAP recordings.

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	Recurrence of AF	The investigators will acquire monophasic action potential from patient's atrium. Then, we will estimate cardiac ion current status of the patients by reverse engineering and computer simulation. The patients will be followed up longer than 12 months based on 2012 ACC/AHA/ESC guidelines. Primary outcomes of the study are AF recurrence and antiarrhythmic drug sensitivity. Those data will be counted and compared with the patient's own ion current status deducted by simulation study with monophasic action potentials.	One year after the last enrollment
Primary	Antiarrhythmic drug sensitivity	The investigators will acquire monophasic action potential from patient's atrium. Then, we will estimate cardiac ion current status of the patients by reverse engineering and computer simulation. The patients will be followed up longer than 12 months based on 2012 ACC/AHA/ESC guidelines. Primary outcomes of the study are AF recurrence and antiarrhythmic drug sensitivity. Those data will be counted and compared with the patient's own ion current status deducted by simulation study with monophasic action potentials.	One year after the last enrollment