Atrial FibrillationNCT02414815
Reverse Prediction of Ion Channel Remodeling in Patients With Atrial Fibrillation Utilizing Monophasic Action Potential and Mathematical Modeling
A study testing Monophasic action potential(MAP) catheter in people with Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Monophasic action potential(MAP) catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Aug 2015to 2 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, 120-752
About this study
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Monophasic action potential(MAP) catheter
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| AF group | Experimental | Atrial fibrillation Receives: Device: Monophasic action potential(MAP) catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: One year after the last enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2015 (estimated)
- Study start28 Aug 2015
- Primary completion2 Mar 2017
- Study completion2 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414815
- Sponsor's protocol ID
- 4-2014-0685
- Status last verified
- Feb 2019
- First submitted
- 3 Apr 2015
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reverse Prediction of Ion Channel Remodeling in Patients With Atrial Fibrillation Utilizing Monophasic Action Potential and Mathematical Modeling
- ClinicalTrials.gov ID
- NCT02414815
- Acronym / sponsor ID
- 4-2014-0685
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 28 Aug 2015
- Primary completion
- 2 Mar 2017 (actual)
- Study completion
- 2 Mar 2017 (actual)
- First posted
- 13 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AF group | Experimental | Device: Monophasic action potential(MAP) catheterAtrial fibrillation |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monophasic action potential(MAP) catheterAfter 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. | Device | AF group |
Primary outcome
Recurrence of AF
Time frame: One year after the last enrollment
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
Time frame: One year after the last enrollment
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monophasic action potential(MAP) catheter in people with Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of AF (time frame: One year after the last enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.