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

NCT03350581 | Completed

• 1 other identifier: KUGH17237 (MICRO-AF)
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Atrial Fibrillation

Keywords

Catheter ablation; Fast anatomical mapping (FAM); Computed tomography (CT); Magnetic resonance image (MRI); Contact force; Atrial fibrillation

Outcome Measures

Primary Outcomes (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.

  Within 1 year after the ablation procedure

Secondary Outcomes (6)

• Contact Force distribution during procedure (g/cm2)

  during procedure

• Rate of bidirectional conduction block

  during procedur

• Percentage of pulmonary vein isolation

  during procedure

• Total procedural time

  during procedure

• Total cumulative amount of radiation exposure

  during procedure

Study Arms (2)

FAM-CT 3D map group

ACTIVE COMPARATOR

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

FAM 3D map group

EXPERIMENTAL

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

Procedure: FAM 3D map group

Interventions

FAM 3D map group PROCEDURE

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

FAM 3D map group

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.

FAM-CT 3D map group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Guro Hospital: lead
• Johnson & Johnson: collaborator

Study Sites (2)

Korea University Guro Hospital

Seoul, Guro-gu, 08308, South Korea

Location

Bucheon Sejong Hospital

Bucheon-si, 14754, South Korea

Location

Related Publications (11)

• 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.

  PMID: 18362429 BACKGROUND

• 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.

  PMID: 16214831 BACKGROUND

• 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.

  PMID: 22820056 BACKGROUND

• 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.

  PMID: 21872560 BACKGROUND

• 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.

  PMID: 18577508 BACKGROUND

• 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.

  PMID: 16643352 BACKGROUND

• 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.

  PMID: 16989651 BACKGROUND

• 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.

  PMID: 18931059 BACKGROUND

• 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.

  PMID: 27152144 BACKGROUND

• 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.

  PMID: 23725815 BACKGROUND

• 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.

  PMID: 27755137 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hong Euy Lim, MD, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 22, 2017
• Study Start: November 21, 2017
• Primary Completion: August 20, 2019
• Study Completion: November 30, 2019
• Last Updated: December 3, 2019

Record last verified: 2019-12

Locations

KR (2)