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Completed

NCT Number: NCT03350581

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korea University Guro Hospital, Seoul, Guro-gu, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FAM 3D map group

Procedure

Radiofrequency catheter ablation using the 3D map which is constructed by FAM alone.

FAM-CT 3D map group

Procedure

Radiofrequency catheter ablation using the 3D map which is constructed by the integration of the FAM with CT or MRI.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.)

  2. Rate of bidirectional conduction block

    Time frame: during procedur

    in linear ablation line

  3. Percentage of pulmonary vein isolation

    Time frame: during procedure

    with one encircling line

  4. Total procedural time

    Time frame: during procedure

    Time duration from the transseptal puncture to the end of the procedure

  5. Total cumulative amount of radiation exposure

    Time frame: during procedure

    related with the procedure

  6. Procedure-related complication rate

    Time frame: Within 1 year after the ablation procedure

    any adverse events

Sponsors and collaborators

Lead sponsor

Korea University Guro Hospital

Other

Collaborators

  • Johnson & Johnson

Registry information

Official study title

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

Acronym: MICRO-AF

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 22, 2017
Registry last updated
Dec 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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