Atrial FibrillationTAILORNCT03759912
Ultra-High-Resolution Mapping Guided Partial Antral Ablation for AF
An observational study of Atrial Fibrillation, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial summary
The electrical isolation of the pulmonary veins (PVI) is the cornerstone of current ablation techniques for the treatment of atrial fibrillation (AF) because the PV is the most common trigger of AF. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 75 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Nov 2018to 7 Aug 2021
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Paroxysmal atrial fibrillation patients who received pulmonary vein isolation using Rhythmia HDx mapping system in Keimyung University Dongsan Medical Center.
Who may be able to join
- Age over 20 years old and under 80 years old
- Patients with non-valvular paroxysmal atrial fibrillation
- Patients having atrial fibrillation even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks
- Patients who could have informed consent
- Patients who are available for a follow-up of more than at least three months after the catheter ablation
Who cannot join
- Patients unsuitable for catheter ablation due to a previous history of pulmonary surgery or structural heart disease
- Patients who cannot receive standard treatments such as anticoagulation therapy needed before the radiofrequency catheter ablation
- Patients in the subject group vulnerable to a clinical study
- Patients who had undergone a prior catheter ablation for atrial fibrillation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Ultra-High-Resolution Mapping Guided Partial Antral Ablation for Atrial Fibrillation
The electrical isolation of the pulmonary veins (PVI) is the cornerstone of current ablation techniques for the treatment of atrial fibrillation (AF) because the PV is the most common trigger of AF. Wide bi-antral circumferential ablation (WACA) is more effective than segmental PV isolation in achieving freedom from total atrial tachyarrhythmia recurrence at long-term follow-up. Therefore, it is widely accepted as initial ablation strategy. However, the WACA technique requires a much larger number of ablation and higher energy to achieve complete isolation because of thick atrial myocardial sleeves with multiple muscle layers present in most of the PV antrum, which is less likely to achieve homogenous transmural lesions in the entire circumference with the currently available ablation technologies. Meanwhile, muscular discontinuities and abrupt changes of the fiber orientation in human PV-Left atrium (LA) junction are previously reported, and electrical PV isolation can usually be achieved without complete circumferential ablation. However, the current electroanatomical mapping (EAM) system has a limitation to understand the complex relationship of PV-LA junction mainly due to relatively low resolution.
The Rhythmia mapping system (BostonScientific, Inc, Cambridge, MA) is a new system provides ultra-high-resolution EAM using a small basket array of 64 electrodes (IntellaMap Orion, Boston Scientific). Owing to better resolution, this new system capable of rapidly and accurately identify critical isthmuses and low-voltage regions of interest and also allows automatic acquisition and accurate annotation of the electrograms, without the need for manual correction.
In this context, we hypothesized that rapid and precise identification of activation pattern of PV-LA junction by Rhythmia system could allow complete, durable electrical isolation of PVs without circumferential antral ablation.
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation ablation, Pulmonary vein, Ultra high resolution mapping
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PVI using Ultra-High-Resolution Mapping | The paroxysmal atrial fibrillation patients who received pulmonary vein antral catheter ablation for electrical isolation of pulmonary veins using ultra-high-resolution mapping system (Rhythmia High Density mapping system). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial arrhythmia recurrence
recurrence of atrial tachyarrhythmia after the index procedure
Measured: one year
Secondary outcomes (7)
acute pulmonary vein isolation rate
Percentage of patients who are able to obtain pulmonary vein isolation during the procedure
Measured: During procedure
acute pulmonary vein reconnection rate
Percentage of patients who achieve pulmonary vein isolation during the procedure but have PV reconnection within the procedure
Measured: During procedure
percentage of ablation area in the antrum
Area of pulmonary vein antrum ablated to obtain pulmonary vein isolation
Measured: During procedure
Procedural outcome
procedure time in minute
Measured: During procedure
Procedural outcome
fluoroscopic time in minute
Measured: During procedure
Procedural outcome
total ablation time in minute
Measured: During procedure
Procedural outcome
procedural complications - number of patients who experienced complications
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start20 Nov 2018
- Primary completion5 Aug 2020
- Study completion7 Aug 2021
Why it stopped: The trial stopped prematurely because of enrollment challenges.
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Seongwook Han, Keimyung University Dongsan Medical Center
- Investigators
- Seongwook Han, MD, PhD, Principal investigator, Keimyung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759912
- Sponsor's protocol ID
- 2018-07-008
- Acronym
- TAILOR
- Status last verified
- May 2023
- First submitted
- 25 Nov 2018
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Ultra-High-Resolution Mapping Guided Partial Antral Ablation for Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03759912
- Acronym / sponsor ID
- TAILOR / 2018-07-008
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation ablation, Pulmonary vein, Ultra high resolution mapping
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The trial stopped prematurely because of enrollment challenges.
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 5 Aug 2020 (actual)
- Study completion
- 7 Aug 2021 (actual)
- First posted
- 30 Nov 2018 (actual)
- 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.
The electrical isolation of the pulmonary veins (PVI) is the cornerstone of current ablation techniques for the treatment of atrial fibrillation (AF) because the PV is the most common trigger of AF. Wide bi-antral circumferential ablation (WACA) is more effective than segmental PV isolation in achieving freedom from total atrial tachyarrhythmia recurrence at long-term follow-up. Therefore, it is widely accepted as initial ablation strategy. However, the WACA technique requires a much larger number of ablation and higher energy to achieve complete isolation because of thick atrial myocardial sleeves with multiple muscle layers present in most of the PV antrum, which is less likely to achieve homogenous transmural lesions in the entire circumference with the currently available ablation technologies. Meanwhile, muscular discontinuities and abrupt changes of the fiber orientation in human PV-Left atrium (LA) junction are previously reported, and electrical PV isolation can usually be achieved without complete circumferential ablation. However, the current electroanatomical mapping (EAM) system has a limitation to understand the complex relationship of PV-LA junction mainly due to relatively low resolution.
The Rhythmia mapping system (BostonScientific, Inc, Cambridge, MA) is a new system provides ultra-high-resolution EAM using a small basket array of 64 electrodes (IntellaMap Orion, Boston Scientific). Owing to better resolution, this new system capable of rapidly and accurately identify critical isthmuses and low-voltage regions of interest and also allows automatic acquisition and accurate annotation of the electrograms, without the need for manual correction.
In this context, we hypothesized that rapid and precise identification of activation pattern of PV-LA junction by Rhythmia system could allow complete, durable electrical isolation of PVs without circumferential antral ablation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PVI using Ultra-High-Resolution Mapping | – | –The paroxysmal atrial fibrillation patients who received pulmonary vein antral catheter ablation for electrical isolation of pulmonary veins using ultra-high-resolution mapping system (Rhythmia High Density mapping system). |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Paroxysmal atrial fibrillation patients who received pulmonary vein isolation using Rhythmia HDx mapping system in Keimyung University Dongsan Medical Center.
Key inclusion criteria (5 listed)
- Age over 20 years old and under 80 years old
- Patients with non-valvular paroxysmal atrial fibrillation
- Patients having atrial fibrillation even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks
- Patients who could have informed consent
- Patients who are available for a follow-up of more than at least three months after the catheter ablation
Key exclusion criteria (4 listed)
- Patients unsuitable for catheter ablation due to a previous history of pulmonary surgery or structural heart disease
- Patients who cannot receive standard treatments such as anticoagulation therapy needed before the radiofrequency catheter ablation
- Patients in the subject group vulnerable to a clinical study
- Patients who had undergone a prior catheter ablation for atrial fibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Atrial arrhythmia recurrence
Time frame: one year
recurrence of atrial tachyarrhythmia after the index procedure
7 secondary outcomes
acute pulmonary vein isolation rate
Time frame: During procedure
acute pulmonary vein reconnection rate
Time frame: During procedure
percentage of ablation area in the antrum
Time frame: During procedure
Procedural outcome
Time frame: During procedure
Procedural outcome
Time frame: During procedure
Procedural outcome
Time frame: During procedure
Procedural outcome
Time frame: During procedure
Results and safety
The study was stopped early (reason given: The trial stopped prematurely because of enrollment challenges.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
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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.
Seongwook Han, MD, PhD principal investigator
Keimyung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Keimyung University Dongsan Medical Center 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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 31 May 2023. 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 was stopped early (reason given: The trial stopped prematurely because of enrollment challenges.). Results are not available in the source record.
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?
Atrial arrhythmia recurrence (time frame: one year). 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 31 May 2023.