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Clinical Benefits of Additional Complex Fractionated Atrial Electrogram Targeted Catheter Ablation for Longstanding Persistent Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT02175043
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:

1. Purpose of the study

1) To compare clinical outcome, procedure time, complication rate of persistent atrial fibrillation patients between conventional additional linear ablation and additional complex fractionated atrial electrogram targeted catheter ablation.

2. Scientific evidence of the study

  1. In atrial fibrillation patients, the maintenance of normal sinus rhythm showed significant reduction of mortality.
  2. drug therapy with anti-arrhythmic drug showed many complications and side effect, thus non-drug therapy such as catheter ablation is developed.
  3. catheter ablation has been performed for 10years world-wide, and showed superior treatment outcome compared with drug therapy.
  4. However, there are no consensus for proper ablation strategy in longstanding persistent atrial fibrillation.
  5. additional ablation make extent of myocardial injury and paradoxically increase recurrence rate, thus still controversial.
  6. Therefore, we will compare conventional linear ablation with additional complex fractionated atrial electrogram targeted catheter ablation.

3. Methods

  1. Treatment of All patients with atrial fibrillation is performed according to the standard treatment guideline of atrial fibrillation.
  2. there is no additional blood sampling, imaging study, or any other invasive procedure according to the inclusion of the study.

4. study contents

  1. to evaluate superior ablation strategy in longstanding persistent atrial fibrillation

    • compare conventional linear ablation with additional complex fractionated atrial electrogram targeted catheter ablation. both strategies are conventional ablation strategies being performed world-wide.
  2. compare complex fractionated atrial electrogram before and after linear ablation.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: atrial electrogram and liner ablation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Actual Study Start Date : June 3, 2014
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: the operation to add in CFAE to conventional liner ablation
The group of positive control is the operation to add in CFAE to conventional liner ablation in persistent atrial fibrillation patients
Procedure: atrial electrogram and liner ablation
  1. The group of positive control is the operation to add in CFAE to conventional liner ablation in persistent atrial fibrillation patients
  2. The group of negative is the operation to only doing conventional liner ablation with persistent atrial fibrillation

Active Comparator: only doing conventional liner ablation
The group of negative is the operation to only doing conventional liner ablation with persistent atrial fibrillation
Procedure: atrial electrogram and liner ablation
  1. The group of positive control is the operation to add in CFAE to conventional liner ablation in persistent atrial fibrillation patients
  2. The group of negative is the operation to only doing conventional liner ablation with persistent atrial fibrillation




Primary Outcome Measures :
  1. number of Clinical recurrence of atrial fibrillation (AF) after catheter ablation [ Time Frame: 1 year ]
    lifelong, checked per every outpatient clinic visit



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1) patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation

Exclusion Criteria:

  1. patients who do not agree with study inclusion
  2. permanent AF refractory to electrical cardioversion
  3. AF with valvular disease ≥ grade 2
  4. Patients with left atrial diameter greater than 60mm
  5. patients with age less than 19

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): NCT02175043


Locations
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Korea, Republic of
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02175043    
Other Study ID Numbers: 4-2014-0282
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Keywords provided by Yonsei University:
atrial fibrillation, catheter ablation, recurrence
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes