Clinical trial NCT02979847: Epicardial Approach in Recurred Atrial Fibrillation
Official title: Role of Epicardial Mapping and Ablation for Redo Procedure in Patients With Non-paroxysmal Atrial Fibrillation: a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: persistent atrial fibrillation
catheter ablation
epicardial mapping and ablation
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2016-12-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Freedom from AF/AT recurrence
timeFrame: 12 months
Secondary outcomes:
measure: Freedom from AF/AT recurrence without anti-arrhythmic drug use
timeFrame: 12 months
measure: Freedom from AF recurrence
timeFrame: 12 months
measure: Freedom from AT recurrence
timeFrame: 12 months
measure: Procedure Time
timeFrame: Immediately after procedure
measure: Fluoroscopic Time
timeFrame: Immediately after procedure
measure: Ablation Time
timeFrame: Immediately after procedure
measure: Procedure-related Acute Complications
timeFrame: Immediately after procedure
measure: Procedure-related Subacute Complications
timeFrame: 3 months after procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Medical Center Anam hospital
Study officials:
affiliation: Korea University
name: Young-Hoon Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.