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

Atrial Fibrillation Clinical Trial

— MICRO-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03350581
• Other study ID #: KUGH17237 (MICRO-AF)
• Status: Completed
• Phase: N/A
• Start date: November 21, 2017
• Est. completion date: November 30, 2019

Study information

• Verified date: December 2019
• Source: Korea University Guro Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 the 3D map constructed by FAM only.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 30, 2019
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• FAM 3D map group
Radiofrequency catheter ablation using the 3D map which is constructed by FAM alone.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Bucheon Sejong Hospital	Bucheon
Korea, Republic of	Korea University Guro Hospital	Seoul	Guro-gu

Sponsors (2)

Lead Sponsor	Collaborator
Korea University Guro Hospital	Johnson & Johnson

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (11)

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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Kuck KH, Reddy VY, Schmidt B, Natale A, Neuzil P, Saoudi N, Kautzner J, Herrera C, Hindricks G, Jaïs 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. — View 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. — View 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. — View 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. — View Citation

Reddy VY, Shah D, Kautzner J, Schmidt B, Saoudi N, Herrera C, Jaïs 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. — View 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. Epub 2005 Oct 7. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

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