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Epicardial Approach in Recurred Atrial Fibrillation (EPIREAF)

Primary Purpose

Persistent Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
hybrid approach
conventional endocardial approach
Sponsored by
Korea University Anam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring persistent atrial fibrillation, catheter ablation, epicardial mapping and ablation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Korea University Medical Center Anam hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treated

Control

Arm Description

hybrid approach (epicardial and subsequent endocardial mappings and ablations)

conventional endocardial approach

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Freedom from AF/AT recurrence without anti-arrhythmic drug use
Freedom from sustained AF/AT recurrence without anti-arrhythmic drug use
Freedom from AF recurrence
Freedom from sustained AF recurrence
Freedom from AT recurrence
Freedom from sustained AT recurrence
Procedure Time
From skin to skin
Fluoroscopic Time
Fluoroscopic Time
Ablation Time
Ablation Time
Procedure-related Acute Complications
Procedure-related Acute Complications
Procedure-related Subacute Complications
Procedure-related Subacute Complications

Full Information

First Posted
September 11, 2016
Last Updated
November 16, 2020
Sponsor
Korea University Anam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02979847
Brief Title
Epicardial Approach in Recurred Atrial Fibrillation
Acronym
EPIREAF
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 29, 2016 (Actual)
Primary Completion Date
May 29, 2020 (Actual)
Study Completion Date
November 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Anam Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
Keywords
persistent atrial fibrillation, catheter ablation, epicardial mapping and ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treated
Arm Type
Experimental
Arm Description
hybrid approach (epicardial and subsequent endocardial mappings and ablations)
Arm Title
Control
Arm Type
Active Comparator
Arm Description
conventional endocardial approach
Intervention Type
Procedure
Intervention Name(s)
hybrid approach
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
conventional endocardial approach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Freedom from AF/AT recurrence
Description
Freedom from sustained AF/AT recurrence Sustained AF/AT: sustained more than 30 sec documentation in clinical electrocardiography, Holter, event recorder
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Freedom from AF/AT recurrence without anti-arrhythmic drug use
Description
Freedom from sustained AF/AT recurrence without anti-arrhythmic drug use
Time Frame
12 months
Title
Freedom from AF recurrence
Description
Freedom from sustained AF recurrence
Time Frame
12 months
Title
Freedom from AT recurrence
Description
Freedom from sustained AT recurrence
Time Frame
12 months
Title
Procedure Time
Description
From skin to skin
Time Frame
Immediately after procedure
Title
Fluoroscopic Time
Description
Fluoroscopic Time
Time Frame
Immediately after procedure
Title
Ablation Time
Description
Ablation Time
Time Frame
Immediately after procedure
Title
Procedure-related Acute Complications
Description
Procedure-related Acute Complications
Time Frame
Immediately after procedure
Title
Procedure-related Subacute Complications
Description
Procedure-related Subacute Complications
Time Frame
3 months after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Hoon Kim, MD, PhD
Organizational Affiliation
Korea University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Medical Center Anam hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The individual participant data is not available to share with other researchers.
Citations:
PubMed Identifier
23512204
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.
Results Reference
result
PubMed Identifier
23935092
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.
Results Reference
result
PubMed Identifier
21907170
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.
Results Reference
result
PubMed Identifier
17573836
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.
Results Reference
result
PubMed Identifier
23390124
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.
Results Reference
result
PubMed Identifier
22331500
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.
Results Reference
result

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Epicardial Approach in Recurred Atrial Fibrillation

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