Epicardial Approach in Recurred Atrial Fibrillation (EPIREAF)

Role of Epicardial Mapping and Ablation for Redo Procedure in Patients With Non-paroxysmal Atrial Fibrillation: a Prospective Randomized Trial

We aimed to assess the benefit of epicardial mapping and ablation in patients with recurred atrial tachyarrhythmias after single procedure for atrial fibrillation. We hypothesize that both endocardial and epicardial approach is superior to only endocardial approach with regards to clinical recurrence. Participants are randomized into a hybrid approach or an endocardial approach.

Study Overview

• Status: Completed
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Procedure: hybrid approach; Procedure: conventional endocardial approach

Detailed Description

Atrial electrical activity during atrial fibrillation depends on the distribution of myocardial tissue. Circumferential and longitudinal muscular bundles are multi-level crossing across the entire thickness of atrial wall. At radiofrequency catheter ablation for atrial fibrillation, transmural lesions are important to reduce the arrhythmogenic substrates and to prevent recurrence of scar-related atrial tachyarrhythmias.

Radiofrequency ablation applying electric current depends on impedance between patch and the tip electrode of a catheter. Increased impedance results in increased tissue heating, following an irreversible damage. However, overheating limits to create deep lesion formation because an increased impedance impedes the energy delivery to tissue. Furthermore, prolonged ablation time may result in severe complications, such as steam pop, cardiac perforation, and char formation. Therefore, both endocardial and epicardial ablations may be more effective to create a transmural lesion compared with only endocardial ablation.

Organized atrial tachycardia is common in patient who underwent ablation for atrial fibrillation. Activation mapping for atrial tachycardia is critical for ablating an isthmus. However, when the amplitude of endocardial potentials after previous ablations is decreased as system does not detect, summation of data from endocardium may give us wrong information about atrial tachycardia. Data from epicardial potential during tachycardia may be helpful to terminate a tachycardia.

We aimed to assess the benefit of epicardial mapping and ablation in patients with recurred atrial tachyarrhythmias after single procedure for atrial fibrillation. We hypothesize that both endocardial and epicardial approach is superior to only endocardial approach with regards to clinical recurrence. Participants are randomized into a hybrid approach or an endocardial approach.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 02841
    • Korea University Medical Center Anam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with persistent AF (AF episode lasting > 7 days)
• Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication
• Patients with recurrent arrhythmia after prior catheter ablation
• Patients undergoing a repeat ablation procedure for AF
• At least one episode of AF must have been documented by ECG, Holter, loop recorder, telemetry, trans telephonic monitoring (TTM), or implantable device within last 2 years of enrollment in this investigation
• Patients must be able and willing to provide written informed consent to participate in this investigation

Exclusion Criteria:

• Patients with permanent AF;
• Permanent AF will be defined as a sustained episode lasting more than 1 years and sinus rhythm never be observed .
• Patients for whom cardioversion or sinus rhythm will never be attempted/pursued;
• Patients with AF felt to be secondary to an obvious reversible cause
• Patients with contraindications to systemic anticoagulation with heparin or warfarin or a direct thrombin inhibitor;
• Moderate to severe valvular disease
• Patients who are pregnant. Pregnancy will be assessed by patients informing the physicians.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treated; hybrid approach (epicardial and subsequent endocardial mappings and ablations)	Procedure: hybrid approach; Before transseptal puncture, epicardial puncture is performed through subxyphoid approach. Atrial epicardial potentials are recorded using multi-electrode catheter, leading an activation map for atrial tachycardia and map for continuous fractionated atrial electrograms during atrial fibrillation. Endocardial potentials are also recorded in the same fashion. Procedural endpoint is a tachycardia termination or a noninducibility of tachycardia.
ACTIVE_COMPARATOR: Control; conventional endocardial approach	Procedure: conventional endocardial approach; Atrial endocardial potentials are recorded using multi-electrode catheter, leading an activation map for atrial tachycardia and map for continuous fractionated atrial electrograms during atrial fibrillation. Procedural endpoint is a tachycardia termination or a noninducibility of tachycardia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from AF/AT recurrence	Freedom from sustained AF/AT recurrence Sustained AF/AT: sustained more than 30 sec documentation in clinical electrocardiography, Holter, event recorder	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from AF/AT recurrence without anti-arrhythmic drug use	Freedom from sustained AF/AT recurrence without anti-arrhythmic drug use	12 months
Freedom from AF recurrence	Freedom from sustained AF recurrence	12 months
Freedom from AT recurrence	Freedom from sustained AT recurrence	12 months
Procedure Time	From skin to skin	Immediately after procedure
Fluoroscopic Time	Fluoroscopic Time	Immediately after procedure
Ablation Time	Ablation Time	Immediately after procedure
Procedure-related Acute Complications	Procedure-related Acute Complications	Immediately after procedure
Procedure-related Subacute Complications	Procedure-related Subacute Complications	3 months after procedure

Collaborators and Investigators

• Sponsor: Korea University Anam Hospital
• Investigators: Principal Investigator: Young-Hoon Kim, MD, PhD, Korea University

Publications and helpful links

General Publications

• Eckstein J, Zeemering S, Linz D, Maesen B, Verheule S, van Hunnik A, Crijns H, Allessie MA, Schotten U. Transmural conduction is the predominant mechanism of breakthrough during atrial fibrillation: evidence from simultaneous endo-epicardial high-density activation mapping. Circ Arrhythm Electrophysiol. 2013 Apr;6(2):334-41. doi: 10.1161/CIRCEP.113.000342. Epub 2013 Mar 19.
• Lee G, Kumar S, Teh A, Madry A, Spence S, Larobina M, Goldblatt J, Brown R, Atkinson V, Moten S, Morton JB, Sanders P, Kistler PM, Kalman JM. Epicardial wave mapping in human long-lasting persistent atrial fibrillation: transient rotational circuits, complex wavefronts, and disorganized activity. Eur Heart J. 2014 Jan;35(2):86-97. doi: 10.1093/eurheartj/eht267. Epub 2013 Aug 8.
• Lee G, Spence S, Teh A, Goldblatt J, Larobina M, Atkinson V, Brown R, Morton JB, Sanders P, Kistler PM, Kalman JM. High-density epicardial mapping of the pulmonary vein-left atrial junction in humans: insights into mechanisms of pulmonary vein arrhythmogenesis. Heart Rhythm. 2012 Feb;9(2):258-64. doi: 10.1016/j.hrthm.2011.09.010. Epub 2011 Sep 9.
• Pak HN, Hwang C, Lim HE, Kim JS, Kim YH. Hybrid epicardial and endocardial ablation of persistent or permanent atrial fibrillation: a new approach for difficult cases. J Cardiovasc Electrophysiol. 2007 Sep;18(9):917-23. doi: 10.1111/j.1540-8167.2007.00882.x. Epub 2007 Jun 16.
• Verheule S, Tuyls E, Gharaviri A, Hulsmans S, van Hunnik A, Kuiper M, Serroyen J, Zeemering S, Kuijpers NH, Schotten U. Loss of continuity in the thin epicardial layer because of endomysial fibrosis increases the complexity of atrial fibrillatory conduction. Circ Arrhythm Electrophysiol. 2013 Feb;6(1):202-11. doi: 10.1161/CIRCEP.112.975144. Epub 2013 Feb 6.
• Eckstein J, Schotten U. Rotors and breakthroughs as three-dimensional perpetuators of atrial fibrillation. Cardiovasc Res. 2012 Apr 1;94(1):8-9. doi: 10.1093/cvr/cvs093. Epub 2012 Feb 13. No abstract available.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 29, 2016
• Primary Completion (ACTUAL): May 29, 2020
• Study Completion (ACTUAL): November 11, 2020

Study Registration Dates

• First Submitted: September 11, 2016
• First Submitted That Met QC Criteria: November 29, 2016
• First Posted (ESTIMATE): December 2, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: catheter ablation; persistent atrial fibrillation; epicardial mapping and ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2016AN0127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data is not available to share with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No