Epicardial Approach in Recurred Atrial Fibrillation

Persistent Atrial Fibrillation Clinical Trial

— EPIREAF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02979847
• Other study ID #: 2016AN0127
• Status: Completed
• Phase: N/A
• Start date: June 29, 2016
• Est. completion date: November 11, 2020

Study information

• Verified date: November 2020
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 11, 2020
• Est. primary completion date: May 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Medical Center Anam hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (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. — View 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 — View 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, comp — View 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 arrhythmoge — View 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. Epub 2007 Jun 16. — View 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 conducti — View Citation

Outcome

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