Clinical trial NCT03836092: ECGI in Patients With Persistent Atrial Fibrillation
Official title: Identification of AF Triggers, Initiators and Perpetuators by Electro Cardio-Graphic Imaging (ECGI) in Patients With Persistent Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Pacific Rim Electrophysiology Research Institute
Sponsor class: OTHER
First posted: 2019-02-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient population will include symptomatic persistent AF patients (N=50). The total of fifty patients will be studied.

Brief summary: To determine the values and limitations of ECGI in guiding ablation and risk stratification in patients with persistent atrial fibrillation.

Detailed description: The patient population will include symptomatic persistent AF patients (N=50). The total of fifty patients will be studied to determine:

* The values and limitations of ECGI in identifying atrial fibrillation (AF) triggers, AF initiators and AF perpetuators as targets sites for catheter ablations in patients with persistent AF.
* The mechanisms of residual atrial tachycardia/flutter (Res-AT/AFl) after AF substrate ablations by targeting complex fractionated atrial electrograms (CFAE).
* If there is a relationship between primary CFAE sites and driver sites or other distinct patterns from the ECGI mapping system.
* The rate of AF termination to sinus rhythm after ablation at target sites identified by ECGI

Eligibility criteria: Inclusion Criteria:

* Patients are diagnosed as persistent AF. Persistent AF was defined as continuous AF from 7 days to 12 months and long- lasting AF beyond twelve months.
* Patients who are symptomatic
* Patients who are willing to sign consent and be followed post procedure in an out- patient arrhythmia clinic

Exclusion Criteria:

* Patients under 18 years or over 85 years of age.
* Patients with chronic alcoholism.
* Recent myocardial infarction within one month of the study.
* Significant debilitating diseases or a terminal disease.
* Patients with documented left atrial thrombus.
* Medical or mental conditions precluding a long-term follow-up.

Primary outcomes:
measure: Freedom from Atrial Fibrillation
timeFrame: 1 year
Secondary outcomes:
measure: termination via ablation from atrial fibrillation during procedure
timeFrame: over 6 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Bumrungrad International Hospital
Study officials:
References:
citation: Nademanee K, McKenzie J, Kosar E, Schwab M, Sunsaneewitayakul B, Vasavakul T, Khunnawat C, Ngarmukos T. A new approach for catheter ablation of atrial fibrillation: mapping of the electrophysiologic substrate. J Am Coll Cardiol. 2004 Jun 2;43(11):2044-53. doi: 10.1016/j.jacc.2003.12.054.
citation: Haissaguerre M, Hocini M, Denis A, Shah AJ, Komatsu Y, Yamashita S, Daly M, Amraoui S, Zellerhoff S, Picat MQ, Quotb A, Jesel L, Lim H, Ploux S, Bordachar P, Attuel G, Meillet V, Ritter P, Derval N, Sacher F, Bernus O, Cochet H, Jais P, Dubois R. Driver domains in persistent atrial fibrillation. Circulation. 2014 Aug 12;130(7):530-8. doi: 10.1161/CIRCULATIONAHA.113.005421. Epub 2014 Jul 15.
citation: Conti S, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P, Verma A. Effect of Different Cutpoints for Defining Success Post-Catheter Ablation for Persistent Atrial Fibrillation: A Substudy of the STAR AF II Trial. JACC Clin Electrophysiol. 2017 May;3(5):522-523. doi: 10.1016/j.jacep.2016.12.006. Epub 2017 May 15. No abstract available.
citation: Oketani N, Seitz J, Salazar M, Pisapia A, Kalifa J, Smit JJ, Nademanee K. Ablation of complex fractionated electrograms is useful for catheter ablation of persistent atrial fibrillation: Protagonist point of view. Heart Rhythm. 2016 Oct;13(10):2098-100. doi: 10.1016/j.hrthm.2016.06.036. Epub 2016 Jul 1. No abstract available.
citation: Nademanee K, Amnueypol M, Lee F, Drew CM, Suwannasri W, Schwab MC, Veerakul G. Benefits and risks of catheter ablation in elderly patients with atrial fibrillation. Heart Rhythm. 2015 Jan;12(1):44-51. doi: 10.1016/j.hrthm.2014.09.049. Epub 2014 Oct 11.