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Ultra-High-Resolution Mapping Guided Partial Antral Ablation for AF (TAILOR)

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ClinicalTrials.gov Identifier: NCT03759912
Recruitment Status : Terminated (The trial stopped prematurely because of enrollment challenges.)
First Posted : November 30, 2018
Last Update Posted : May 31, 2023
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Seongwook Han, Keimyung University Dongsan Medical Center

Study Description
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Brief 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. 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.


Condition or disease
Atrial Fibrillation

Study Design
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Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Efficacy of Ultra-High-Resolution Mapping Guided Partial Antral Ablation for Atrial Fibrillation
Actual Study Start Date : November 20, 2018
Actual Primary Completion Date : August 5, 2020
Actual Study Completion Date : August 7, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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).


Outcome Measures
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Primary Outcome Measures :
  1. Atrial arrhythmia recurrence [ Time Frame: one year ]
    recurrence of atrial tachyarrhythmia after the index procedure


Secondary Outcome Measures :
  1. acute pulmonary vein isolation rate [ Time Frame: During procedure ]
    Percentage of patients who are able to obtain pulmonary vein isolation during the procedure

  2. acute pulmonary vein reconnection rate [ Time Frame: During procedure ]
    Percentage of patients who achieve pulmonary vein isolation during the procedure but have PV reconnection within the procedure

  3. percentage of ablation area in the antrum [ Time Frame: During procedure ]
    Area of pulmonary vein antrum ablated to obtain pulmonary vein isolation

  4. Procedural outcome [ Time Frame: During procedure ]
    procedure time in minute

  5. Procedural outcome [ Time Frame: During procedure ]
    fluoroscopic time in minute

  6. Procedural outcome [ Time Frame: During procedure ]
    total ablation time in minute

  7. Procedural outcome [ Time Frame: During procedure ]
    procedural complications - number of patients who experienced complications


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Paroxysmal atrial fibrillation patients who received pulmonary vein isolation using Rhythmia HDx mapping system in Keimyung University Dongsan Medical Center.
Criteria

Inclusion Criteria:

  1. Age over 20 years old and under 80 years old
  2. Patients with non-valvular paroxysmal atrial fibrillation
  3. Patients having atrial fibrillation even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks
  4. Patients who could have informed consent
  5. Patients who are available for a follow-up of more than at least three months after the catheter ablation

Exclusion Criteria:

  1. Patients unsuitable for catheter ablation due to a previous history of pulmonary surgery or structural heart disease
  2. Patients who cannot receive standard treatments such as anticoagulation therapy needed before the radiofrequency catheter ablation
  3. Patients in the subject group vulnerable to a clinical study
  4. Patients who had undergone a prior catheter ablation for atrial fibrillation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03759912


Locations
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Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of, 41931
Sponsors and Collaborators
Keimyung University Dongsan Medical Center
Boston Scientific Corporation
Investigators
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Principal Investigator: Seongwook Han, MD, PhD Keimyung University
More Information
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Responsible Party: Seongwook Han, Professor, Keimyung University Dongsan Medical Center
ClinicalTrials.gov Identifier: NCT03759912    
Other Study ID Numbers: 2018-07-008
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: May 31, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seongwook Han, Keimyung University Dongsan Medical Center:
Atrial fibrillation ablation
Pulmonary vein
Ultra high resolution mapping
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes