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Does the Merged 3D Imaging Improve Contact Force and Long Term Procedure Outcome in Atrial Fibrillation? (MICRO-AF)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
FAM 3D map group
FAM-CT 3D map group
Sponsored by
Korea University Guro Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Catheter ablation, Fast anatomical mapping (FAM), Computed tomography (CT), Magnetic resonance image (MRI), Contact force, Atrial fibrillation

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing first-time catheter ablation for AF.
  • Willing and able to provide informed consent
  • Age greater than or equal to 18 years.

Exclusion Criteria:

  • Patients who have previously undergone AF ablation
  • Patients with more than mild mitral valve stenosis or mechanical mitral valve replacement
  • Patients with chronic renal impairment with creatinine clearance rate of < 50

Sites / Locations

  • Korea University Guro Hospital
  • Bucheon Sejong Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

FAM-CT 3D map group

FAM 3D map group

Arm Description

Operator will perform radiofrequency catheter ablation using 3D map which is constructed by integration of FAM with CT or MRI.

Operator will perform radiofrequency catheter ablation using 3D map which is constructed by integration of FAM alone.

Outcomes

Primary Outcome Measures

Freedom rate of any atrial tachy-arrhythmia at 1 year after ablation procedure
Any recurrence of ECG or Holter documented sustained AF >30 s duration.

Secondary Outcome Measures

Contact Force distribution during procedure (g/cm2)
Measurements from the SmartTouch™ catheter(Biosense Webster Inc.) integrated with the Carto3®(Biosense Webster Inc.)
Rate of bidirectional conduction block
in linear ablation line
Percentage of pulmonary vein isolation
with one encircling line
Total procedural time
Time duration from the transseptal puncture to the end of the procedure
Total cumulative amount of radiation exposure
related with the procedure
Procedure-related complication rate
any adverse events

Full Information

First Posted
November 15, 2017
Last Updated
December 1, 2019
Sponsor
Korea University Guro Hospital
Collaborators
Johnson & Johnson
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1. Study Identification

Unique Protocol Identification Number
NCT03350581
Brief Title
Does the Merged 3D Imaging Improve Contact Force and Long Term Procedure Outcome in Atrial Fibrillation?
Acronym
MICRO-AF
Official Title
Does the Merged 3D Imaging Improve Contact Force and Long Term Procedure Outcome in Atrial Fibrillation? (MICRO-AF Study)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 21, 2017 (Actual)
Primary Completion Date
August 20, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Guro Hospital
Collaborators
Johnson & Johnson

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to investigate whether or not there are the differences in acute procedure and long-term clinical outcome of radiofrequency catheter ablation (RFCA) for atrial fibrillation (AF) using the 3D map constructed by the integration of CT(or MRI) with the fast anatomical mapping (FAM) versus using the 3D map constructed by FAM only.
Detailed Description
In a recent study, ablation therapy of AF was superior to antiarrhythmic drug therapy alone in preventing atrial arrhythmia recurrences in patients with paroxysmal or persistent AF. Various techniques have been proposed and are currently under investigation in various electrophysiology laboratories, with increasing knowledge of the pathophysiology of human AF and critical assessment of clinical outcome after the procedure. The factors related with the technical success involves appropriate contact force between catheter tip and target tissue for the complete electrical blockade and transmural ablation scar formation through continuous and sufficient energy transfer. For improving contact and energy transfer, it is required to accurately visualize the 3D anatomy of the left atrium in order to reduce fluoroscopic exposure during the procedure. For the purpose, electro-anatomic mapping systems (EAM) are commonly being used to reconstruct a virtual 3D chamber anatomy through the acquisition of a limited number of anatomical surface location points derived from the position of the catheter tip and an extrapolation of the chamber surface in between these acquired anatomical points. Previously, a more detailed appreciation of the complex left atrium (LA) anatomy can be obtained with 3D-anatomical chamber reconstructions derived from the computed tomography (CT) or magnetic resonance imaging(MRI). Integration of EAM with CT (or MRI) was generally regarded as a more accurate method. However, the method needs to be improved since it sometimes generates significant error during the integration process. Recently, volume-rendered 3D imaging can be created more accurately and easily through fast anatomical mapping (FAM) using multi-polar catheter. Furthermore, 3D anatomy obtained by FAM might provide more sophisticated information than that obtained from CT or MRI images since it reflects the real-time physiology and shape of the heart during the ablation procedure. However, there have been no prospective studies investigating that 3D anatomy obtained through which method can help to improve acute or long-term procedural outcome of the ablation procedure as well as reduce procedure-related adverse effects or complications. The purpose of the study is to investigate the differences between the 3D map constructed by the integration of the FAM with CT or MRI (FAM-CT 3D map) and that by FAM (FAM 3D map) alone with respect to following aspects: the contact force between the electrode and the atrial tissue during the ablation procedure; the safety and the procedure-related complications during or after the ablation procedure; the long term procedural outcome after the ablation procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Catheter ablation, Fast anatomical mapping (FAM), Computed tomography (CT), Magnetic resonance image (MRI), Contact force, Atrial fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FAM-CT 3D map group
Arm Type
Active Comparator
Arm Description
Operator will perform radiofrequency catheter ablation using 3D map which is constructed by integration of FAM with CT or MRI.
Arm Title
FAM 3D map group
Arm Type
Experimental
Arm Description
Operator will perform radiofrequency catheter ablation using 3D map which is constructed by integration of FAM alone.
Intervention Type
Procedure
Intervention Name(s)
FAM 3D map group
Intervention Description
Radiofrequency catheter ablation using the 3D map which is constructed by FAM alone.
Intervention Type
Procedure
Intervention Name(s)
FAM-CT 3D map group
Intervention Description
Radiofrequency catheter ablation using the 3D map which is constructed by the integration of the FAM with CT or MRI.
Primary Outcome Measure Information:
Title
Freedom rate of any atrial tachy-arrhythmia at 1 year after ablation procedure
Description
Any recurrence of ECG or Holter documented sustained AF >30 s duration.
Time Frame
Within 1 year after the ablation procedure
Secondary Outcome Measure Information:
Title
Contact Force distribution during procedure (g/cm2)
Description
Measurements from the SmartTouch™ catheter(Biosense Webster Inc.) integrated with the Carto3®(Biosense Webster Inc.)
Time Frame
during procedure
Title
Rate of bidirectional conduction block
Description
in linear ablation line
Time Frame
during procedur
Title
Percentage of pulmonary vein isolation
Description
with one encircling line
Time Frame
during procedure
Title
Total procedural time
Description
Time duration from the transseptal puncture to the end of the procedure
Time Frame
during procedure
Title
Total cumulative amount of radiation exposure
Description
related with the procedure
Time Frame
during procedure
Title
Procedure-related complication rate
Description
any adverse events
Time Frame
Within 1 year after the ablation procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing first-time catheter ablation for AF. Willing and able to provide informed consent Age greater than or equal to 18 years. Exclusion Criteria: Patients who have previously undergone AF ablation Patients with more than mild mitral valve stenosis or mechanical mitral valve replacement Patients with chronic renal impairment with creatinine clearance rate of < 50
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Euy Lim, MD, PhD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
State/Province
Guro-gu
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Bucheon Sejong Hospital
City
Bucheon
ZIP/Postal Code
14754
Country
Korea, Republic of

12. IPD Sharing Statement

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Does the Merged 3D Imaging Improve Contact Force and Long Term Procedure Outcome in Atrial Fibrillation?

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