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Hybrid Catheter Ablation for Persistent Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT02979847
Recruitment Status : Unknown
Verified November 2016 by Young-Hoon Kim, Korea University Anam Hospital.
Recruitment status was:  Recruiting
First Posted : December 2, 2016
Last Update Posted : December 2, 2016
Sponsor:
Information provided by (Responsible Party):
Young-Hoon Kim, Korea University Anam Hospital

Brief Summary:

prospective randomized controlled trial

In repeat procedure for persistent atrial fibrillation, Hybrid group (Epicardial ablation + Endocardial ablation) versus control group (conventional Endocardial ablation)

Freedom from AF/Atrial tachycardia and safety


Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Procedure: hybrid catheter ablation Procedure: conventional endocardial ablation Not Applicable

Detailed Description:

Epicardial (EPI) catheter approach is considered as an accessory to endocardial (ENDO) ablation for persistent atrial fibrillation (PeAF). We evaluated the effectiveness and safety of EPI ablation as first option to the patients who had previous endocardial ablation for PeAF.

This is prospective randomized controlled, single center study. study population is recurred AF patient with failed previous ENDO catheter ablation for PeAF. The investigators randomized study population to both groups: Hybrid group (EpI + ENDO ablation) versus control group (conventional ENDO ablation). Clinical outcome (Freedom from AF/Atrial tachycardia) and procedural safety will be compared.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Epicardial Catheter Ablation in Repeated Procedure for Persistent Atrial Fibrillation: Prospective Randomized Controlled Trial
Study Start Date : June 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hybrid
hybrid catheter ablation (both epicardial and endocardial mapping and ablation)
Procedure: hybrid catheter ablation
trans-xyphoid epicardial puncture is performed and 20-pole catheter via SL-1 sheath is inserted. Voltage mapping or activation mapping or CFAE mapping is performed as rhythm status. Epicardial and Endocardial side ablation were performed.

Active Comparator: Control
conventional mapping and ablation in endocardial side
Procedure: conventional endocardial ablation
trans-femoral puncture is performed. Voltage mapping or activation mapping or CFAE mapping is performed as rhythm status. Endocardial side ablation were performed and Epicardial side is not assessed.




Primary Outcome Measures :
  1. Freedom from AF/AT recurrence [ Time Frame: 12 months ]
    Freedom from sustained AF/AT recurrence without using anti-arrhythmic drug Sustained AF/AT: sustained more than 30 sec documentation in clinical electrocardiography, Holter, event recorder


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events [ Time Frame: 12 months ]
    Procedure related complication requiring surgical manage, transfusion, medical treatment

  2. Predictor for recurrence of AF/AT [ Time Frame: 12 months ]
    To evaluate predictor for recurrence of atrial tachyarrhythmia after repeated catheter ablation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;
  • Patients with left atrial size ≥ 60 mm (2D echocardiography, parasternal long axis view)
  • Moderate to severe valvular disease
  • Reduced left ventricular function (ejection fraction <40%)
  • Patients who are pregnant. Pregnancy will be assessed by patients informing the physicians.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02979847


Contacts
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Contact: Seung-Young Roh, MD +82-10-3612-6876 rsy008@gmail.com
Contact: Kwang No Lee, MD +82-10-9286-1123 knlee81@naver.com

Locations
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Korea, Republic of
Korea University Medical Center Anam hospital Recruiting
Seoul, Korea, Republic of, 02841
Contact: Young-Hoon Kim, President    +82-2-920-5445    yhkmd@unitel.co.kr   
Sponsors and Collaborators
Korea University Anam Hospital
Investigators
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Principal Investigator: Young-Hoon Kim, MD, PhD Korea University

Publications of Results:

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Responsible Party: Young-Hoon Kim, Professor, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT02979847     History of Changes
Other Study ID Numbers: KoreaUAnamH
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Young-Hoon Kim, Korea University Anam Hospital:
persistent atrial fibrillation
catheter ablation
hybrid

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes