Reverse Prediction of Ion Channel Remodeling in Patients With Atrial Fibrillation Utilizing Monophasic Action Potential and Mathematical Modeling
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Monophasic action potential(MAP) catheter
Sponsored by
About this trial
This is an interventional diagnostic trial for Atrial Fibrillation
Eligibility Criteria
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
Sites / Locations
- Severance Cardiovascular Hospital, Yonsei University Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AF group
Arm Description
Atrial fibrillation
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02414815
Brief Title
Reverse Prediction of Ion Channel Remodeling in Patients With Atrial Fibrillation Utilizing Monophasic Action Potential and Mathematical Modeling
Official Title
Reverse Prediction of Ion Channel Remodeling in Patients With Atrial Fibrillation Utilizing Monophasic Action Potential and Mathematical Modeling
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 28, 2015 (undefined)
Primary Completion Date
March 2, 2017 (Actual)
Study Completion Date
March 2, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AF group
Arm Type
Experimental
Arm Description
Atrial fibrillation
Intervention Type
Device
Intervention Name(s)
Monophasic action potential(MAP) catheter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recurrence of AF
Description
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.
Time Frame
One year after the last enrollment
Title
Antiarrhythmic drug sensitivity
Description
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.
Time Frame
One year after the last enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Severance Cardiovascular Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Reverse Prediction of Ion Channel Remodeling in Patients With Atrial Fibrillation Utilizing Monophasic Action Potential and Mathematical Modeling
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