Clinical trial NCT03350581: Does the Merged 3D Imaging Improve Contact Force and Long Term Procedure Outcome in Atrial Fibrillation?
Official title: Does the Merged 3D Imaging Improve Contact Force and Long Term Procedure Outcome in Atrial Fibrillation? (MICRO-AF Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Catheter ablation
Fast anatomical mapping (FAM)
Computed tomography (CT)
Magnetic resonance image (MRI)
Contact force
Atrial fibrillation
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2017-11-22
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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

Primary outcomes:
measure: Freedom rate of any atrial tachy-arrhythmia at 1 year after ablation procedure
timeFrame: Within 1 year after the ablation procedure
Secondary outcomes:
measure: Contact Force distribution during procedure (g/cm2)
timeFrame: during procedure
measure: Rate of bidirectional conduction block
timeFrame: during procedur
measure: Percentage of pulmonary vein isolation
timeFrame: during procedure
measure: Total procedural time
timeFrame: during procedure
measure: Total cumulative amount of radiation exposure
timeFrame: during procedure
measure: Procedure-related complication rate
timeFrame: Within 1 year after the ablation procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Guro-gu
city: Bucheon
country: Korea, Republic of
facility: Bucheon Sejong Hospital
Study officials:
affiliation: Professor
name: Hong Euy Lim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.