ECGI in Patients With Persistent Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Identification of AF Triggers, Initiators and Perpetuators by Electro Cardio-Graphic Imaging (ECGI) in Patients With Persistent Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03836092
• Other study ID #: PACIFICRERI3
• Status: Completed
• Start date: February 23, 2018
• Est. completion date: April 1, 2022

Study information

• Verified date: April 2022
• Source: Pacific Rim Electrophysiology Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Radiofrequency ablation
RF applications were delivered with a maximal temperature of 43°C at the catheter tip (SmartTouch Navistar Thermocool catheter) and at the power between 25-50 watts. The primary end points during RF ablation were either complete elimination of areas with CFAE or conversion of AF to normal sinus rhythm (SR). When areas with CFAE were completely eliminated but the atrial arrhythmias persisted (organized atrial flutter or atrial tachycardia), they were subsequently mapped and ablated (occasionally in conjunction with ibutilide, 1 - 2 mgs intravenously over 10 minutes).

Locations

Country	Name	City	State
Thailand	Bumrungrad International Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Pacific Rim Electrophysiology Research Institute

Country where clinical trial is conducted

Thailand, 

References & Publications (5)

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 P — View 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 d — View 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. — View 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. — View 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. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from Atrial Fibrillation	termination via ablation from atrial fibrillation during follow up period	1 year
Secondary	termination via ablation from atrial fibrillation during procedure	Termination of AF to NSR during procedure	over 6 months