NCT02414815

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable atrial-fibrillation

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 13, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

August 28, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2017

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

1.5 years

First QC Date

April 3, 2015

Last Update Submit

February 25, 2019

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

AF group

EXPERIMENTAL

Atrial fibrillation

Device: Monophasic action potential(MAP) catheter

Interventions

Monophasic action potential(MAP) catheterDEVICE

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.

AF group

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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 or more 75

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Cardiovascular Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheters

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2015

First Posted

April 13, 2015

Study Start

August 28, 2015

Primary Completion

March 2, 2017

Study Completion

March 2, 2017

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations

KR(1)