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

December 1, 2019 updated by: Hong Euy Lim, MD, Korea University Guro Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. the contact force between the electrode and the atrial tissue during the ablation procedure;
  2. the safety and the procedure-related complications during or after the ablation procedure;
  3. the long term procedural outcome after the ablation procedure.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Bucheon, Korea, Republic of, 14754
        • Bucheon Sejong Hospital
    • Guro-gu
      • Seoul, Guro-gu, Korea, Republic of, 08308
        • Korea University Guro Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FAM-CT 3D map group
Operator will perform radiofrequency catheter ablation using 3D map which is constructed by integration of FAM with CT or MRI.
Procedure: FAM-CT 3D map group
Radiofrequency catheter ablation using the 3D map which is constructed by the integration of the FAM with CT or MRI.
Experimental: FAM 3D map group
Operator will perform radiofrequency catheter ablation using 3D map which is constructed by integration of FAM alone.
Procedure: FAM 3D map group
Radiofrequency catheter ablation using the 3D map which is constructed by FAM alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom rate of any atrial tachy-arrhythmia at 1 year after ablation procedure
Time Frame: Within 1 year after the ablation procedure
Any recurrence of ECG or Holter documented sustained AF >30 s duration.
Within 1 year after the ablation procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contact Force distribution during procedure (g/cm2)
Time Frame: during procedure
Measurements from the SmartTouch™ catheter(Biosense Webster Inc.) integrated with the Carto3®(Biosense Webster Inc.)
during procedure
Rate of bidirectional conduction block
Time Frame: during procedur
in linear ablation line
during procedur
Percentage of pulmonary vein isolation
Time Frame: during procedure
with one encircling line
during procedure
Total procedural time
Time Frame: during procedure
Time duration from the transseptal puncture to the end of the procedure
during procedure
Total cumulative amount of radiation exposure
Time Frame: during procedure
related with the procedure
during procedure
Procedure-related complication rate
Time Frame: Within 1 year after the ablation procedure
any adverse events
Within 1 year after the ablation procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Guro Hospital

Collaborators

Johnson & Johnson

Investigators

  • Principal Investigator: Hong Euy Lim, MD, PhD, Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2017

Primary Completion (Actual)

August 20, 2019

Study Completion (Actual)

November 30, 2019

Study Registration Dates

First Submitted

November 15, 2017

First Submitted That Met QC Criteria

November 17, 2017

First Posted (Actual)

November 22, 2017

Study Record Updates

Last Update Posted (Actual)

December 3, 2019

Last Update Submitted That Met QC Criteria

December 1, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUGH17237 (MICRO-AF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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