Epicardial Approach in Recurred Atrial Fibrillation

NCT02979847 | Completed DMC

• 1 other identifier: 2016AN0127
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Persistent Atrial Fibrillation

Keywords

persistent atrial fibrillation; catheter ablation; epicardial mapping and ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Freedom from AF/AT recurrence without anti-arrhythmic drug use

  12 months

• Freedom from AF recurrence

  12 months

• Freedom from AT recurrence

  12 months

• Procedure Time

  Immediately after procedure

• Fluoroscopic Time

  Immediately after procedure

Study Arms (2)

Treated

EXPERIMENTAL

hybrid approach (epicardial and subsequent endocardial mappings and ablations)

Procedure: hybrid approach

Control

ACTIVE COMPARATOR

conventional endocardial approach

Procedure: conventional endocardial approach

Interventions

hybrid approach PROCEDURE

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.

Treated

conventional endocardial approach PROCEDURE

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.

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

Korea University Medical Center Anam hospital

Seoul, 02841, South Korea

Location

Related Publications (6)

• 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.

  PMID: 23512204 RESULT

• 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.

  PMID: 23935092 RESULT

• 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.

  PMID: 21907170 RESULT

• 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.

  PMID: 17573836 RESULT

• 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.

  PMID: 23390124 RESULT

• 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.

  PMID: 22331500 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Young-Hoon Kim, MD, PhD

  Korea University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized

Study Record Dates

• First Submitted: September 11, 2016
• First Posted: December 2, 2016
• Study Start: June 29, 2016
• Primary Completion: May 29, 2020
• Study Completion: November 11, 2020
• Last Updated: November 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)