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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
atrial electrogram and liner ablation
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, catheter ablation, recurrence

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Severance Cardiovascular Hospital, Yonsei University Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

the operation to add in CFAE to conventional liner ablation

only doing conventional liner ablation

Arm Description

The group of positive control is the operation to add in CFAE to conventional liner ablation in persistent atrial fibrillation patients

The group of negative is the operation to only doing conventional liner ablation with persistent atrial fibrillation

Outcomes

Primary Outcome Measures

number of Clinical recurrence of atrial fibrillation (AF) after catheter ablation
lifelong, checked per every outpatient clinic visit

Secondary Outcome Measures

Full Information

First Posted
June 23, 2014
Last Updated
April 24, 2017
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02175043
Brief Title
Clinical Benefits of Additional Complex Fractionated Atrial Electrogram Targeted Catheter Ablation for Longstanding Persistent Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 3, 2014 (Actual)
Primary Completion Date
February 28, 2017 (Actual)
Study Completion Date
February 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 In atrial fibrillation patients, the maintenance of normal sinus rhythm showed significant reduction of mortality. drug therapy with anti-arrhythmic drug showed many complications and side effect, thus non-drug therapy such as catheter ablation is developed. catheter ablation has been performed for 10years world-wide, and showed superior treatment outcome compared with drug therapy. However, there are no consensus for proper ablation strategy in longstanding persistent atrial fibrillation. additional ablation make extent of myocardial injury and paradoxically increase recurrence rate, thus still controversial. Therefore, we will compare conventional linear ablation with additional complex fractionated atrial electrogram targeted catheter ablation. 3. Methods Treatment of All patients with atrial fibrillation is performed according to the standard treatment guideline of atrial fibrillation. there is no additional blood sampling, imaging study, or any other invasive procedure according to the inclusion of the study. 4. study contents 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. compare complex fractionated atrial electrogram before and after linear ablation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, catheter ablation, recurrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the operation to add in CFAE to conventional liner ablation
Arm Type
Experimental
Arm Description
The group of positive control is the operation to add in CFAE to conventional liner ablation in persistent atrial fibrillation patients
Arm Title
only doing conventional liner ablation
Arm Type
Active Comparator
Arm Description
The group of negative is the operation to only doing conventional liner ablation with persistent atrial fibrillation
Intervention Type
Procedure
Intervention Name(s)
atrial electrogram and liner ablation
Intervention Description
The group of positive control is the operation to add in CFAE to conventional liner ablation in persistent atrial fibrillation patients The group of negative is the operation to only doing conventional liner ablation with persistent atrial fibrillation
Primary Outcome Measure Information:
Title
number of Clinical recurrence of atrial fibrillation (AF) after catheter ablation
Description
lifelong, checked per every outpatient clinic visit
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1) patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation Exclusion Criteria: patients who do not agree with study inclusion permanent AF refractory to electrical cardioversion AF with valvular disease ≥ grade 2 Patients with left atrial diameter greater than 60mm patients with age less than 19
Facility Information:
Facility Name
Severance Cardiovascular Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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