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Atrial FibrillationMICRO-AFNCT03350581

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

A study testing FAM 3D map group and FAM-CT 3D map group in people with Atrial Fibrillation, run by Korea University Guro Hospital at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
FAM 3D map group and FAM-CT 3D map group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesSouth Korea
Study dates
21 Nov 2017to 30 Nov 2019
Phase
Interventional
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Bucheon Sejong Hospital

    Bucheon-si, 14754

  • Korea University Guro Hospital

    Seoul, Guro-gu, 08308

Other trials in South Korea

About this study

Official title: 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.

Read the 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.
Being tested
FAM 3D map group, FAM-CT 3D map group
Keywords
Catheter ablation, Fast anatomical mapping (FAM), Computed tomography (CT), Magnetic resonance image (MRI), Contact force, Atrial fibrillation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FAM 3D map groupProcedure or surgery

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

  • FAM-CT 3D map groupProcedure or surgery

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

Study groups in NCT03350581
Study groupRoleWhat they receive
FAM-CT 3D map groupActive comparatorOperator will perform radiofrequency catheter ablation using 3D map which is constructed by integration of FAM with CT or MRI.
Receives: Procedure: FAM-CT 3D map group
FAM 3D map groupExperimentalOperator will perform radiofrequency catheter ablation using 3D map which is constructed by integration of FAM alone.
Receives: Procedure: FAM 3D map group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Within 1 year after the ablation procedure

Secondary outcomes (6)

  1. Contact Force distribution during procedure (g/cm2)

    Measurements from the SmartTouch™ catheter(Biosense Webster Inc.) integrated with the Carto3®(Biosense Webster Inc.)

    Measured: during procedure

  2. Rate of bidirectional conduction block

    in linear ablation line

    Measured: during procedur

  3. Percentage of pulmonary vein isolation

    with one encircling line

    Measured: during procedure

  4. Total procedural time

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

    Measured: during procedure

  5. Total cumulative amount of radiation exposure

    related with the procedure

    Measured: during procedure

  6. Procedure-related complication rate

    any adverse events

    Measured: Within 1 year after the ablation procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2017
  2. Study start21 Nov 2017
  3. Primary completion20 Aug 2019
  4. Study completion30 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03350581
Sponsor's protocol ID
KUGH17237 (MICRO-AF)
Acronym
MICRO-AF
Status last verified
Dec 2019
First submitted
15 Nov 2017
Last updated
3 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Miyazaki S, Kuwahara T, Takahashi A, Kobori A, Takahashi Y, Nozato T, Hikita H, Sato A, Aonuma K, Hirao K, Isobe M. Effect of left atrial ablation on the quality of life in patients with atrial fibrillation. Circ J. 2008 Apr;72(4):582-7. doi: 10.1253/circj.72.582.

    PubMed 18362429

  • Stabile G, Bertaglia E, Senatore G, De Simone A, Zoppo F, Donnici G, Turco P, Pascotto P, Fazzari M, Vitale DF. Catheter ablation treatment in patients with drug-refractory atrial fibrillation: a prospective, multi-centre, randomized, controlled study (Catheter Ablation For The Cure Of Atrial Fibrillation Study). Eur Heart J. 2006 Jan;27(2):216-21. doi: 10.1093/eurheartj/ehi583. Epub 2005 Oct 7.

    PubMed 16214831

  • Reddy VY, Shah D, Kautzner J, Schmidt B, Saoudi N, Herrera C, Jais P, Hindricks G, Peichl P, Yulzari A, Lambert H, Neuzil P, Natale A, Kuck KH. The relationship between contact force and clinical outcome during radiofrequency catheter ablation of atrial fibrillation in the TOCCATA study. Heart Rhythm. 2012 Nov;9(11):1789-95. doi: 10.1016/j.hrthm.2012.07.016. Epub 2012 Jul 20.

    PubMed 22820056

  • Kuck KH, Reddy VY, Schmidt B, Natale A, Neuzil P, Saoudi N, Kautzner J, Herrera C, Hindricks G, Jais P, Nakagawa H, Lambert H, Shah DC. A novel radiofrequency ablation catheter using contact force sensing: Toccata study. Heart Rhythm. 2012 Jan;9(1):18-23. doi: 10.1016/j.hrthm.2011.08.021. Epub 2011 Aug 26.

    PubMed 21872560

  • Piorkowski C, Kircher S, Arya A, Gaspar T, Esato M, Riahi S, Bollmann A, Husser D, Staab C, Sommer P, Hindricks G. Computed tomography model-based treatment of atrial fibrillation and atrial macro-re-entrant tachycardia. Europace. 2008 Aug;10(8):939-48. doi: 10.1093/europace/eun147. Epub 2008 Jun 23.

    PubMed 18577508

  • Kistler PM, Earley MJ, Harris S, Abrams D, Ellis S, Sporton SC, Schilling RJ. Validation of three-dimensional cardiac image integration: use of integrated CT image into electroanatomic mapping system to perform catheter ablation of atrial fibrillation. J Cardiovasc Electrophysiol. 2006 Apr;17(4):341-8. doi: 10.1111/j.1540-8167.2006.00371.x.

    PubMed 16643352

  • Kistler PM, Rajappan K, Jahngir M, Earley MJ, Harris S, Abrams D, Gupta D, Liew R, Ellis S, Sporton SC, Schilling RJ. The impact of CT image integration into an electroanatomic mapping system on clinical outcomes of catheter ablation of atrial fibrillation. J Cardiovasc Electrophysiol. 2006 Oct;17(10):1093-101. doi: 10.1111/j.1540-8167.2006.00594.x.

    PubMed 16989651

  • Kistler PM, Rajappan K, Harris S, Earley MJ, Richmond L, Sporton SC, Schilling RJ. The impact of image integration on catheter ablation of atrial fibrillation using electroanatomic mapping: a prospective randomized study. Eur Heart J. 2008 Dec;29(24):3029-36. doi: 10.1093/eurheartj/ehn453. Epub 2008 Oct 17.

    PubMed 18931059

  • Marai I, Suleiman M, Blich M, Lessick J, Abadi S, Boulos M. Impact of computed tomography image and contact force technology on catheter ablation for atrial fibrillation. World J Cardiol. 2016 Apr 26;8(4):317-22. doi: 10.4330/wjc.v8.i4.317.

    PubMed 27152144

  • Im SI, Shin SY, Na JO, Kim YH, Choi CU, Kim SH, Kim JW, Kim EJ, Han SW, Rha SW, Park CG, Seo HS, Oh DJ, Hwang C, Lim HE. Usefulness of neutrophil/lymphocyte ratio in predicting early recurrence after radiofrequency catheter ablation in patients with atrial fibrillation. Int J Cardiol. 2013 Oct 9;168(4):4398-400. doi: 10.1016/j.ijcard.2013.05.042. Epub 2013 May 28. No abstract available.

    PubMed 23725815

  • Ha AC, Wijeysundera HC, Birnie DH, Verma A. Real-world outcomes, complications, and cost of catheter-based ablation for atrial fibrillation: an update. Curr Opin Cardiol. 2017 Jan;32(1):47-52. doi: 10.1097/HCO.0000000000000348.

    PubMed 27755137

Questions about this trial

What is this clinical trial studying?

A study testing FAM 3D map group and FAM-CT 3D map group in people with Atrial Fibrillation, run by Korea University Guro Hospital at 2 sites 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Freedom rate of any atrial tachy-arrhythmia at 1 year after ablation procedure (time frame: Within 1 year after the ablation procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03350581, which also lists 11 linked publications.

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 3 Dec 2019.

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