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Impedance vs. Contact Force Guided Atrial Fibrillation Ablation Using Automated Annotation System

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ablation
Sponsored by
Keimyung University Dongsan Medical Center
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

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with non-valvular atrial fibrillation
  • Patients having atrial fibrillation even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks
  • Patients with tachycardia-bradycardia syndrome associated with atrial fibrillation.
  • Patients who can understand the information sheet and consent form on the need and procedure of catheter ablation and submitted them
  • Patients who are available of follow-up at least for more than three months after catheter ablation

Exclusion Criteria:

  • Patients unsuitable for catheter ablation because the size of left atrium is over 5.5cm
  • Patients unsuitable for catheter ablation due to previous history of pulmonary surgery or structural heat disease.
  • Patients who cannot receive standard treatments such as anticoagulation therapy which need to be continuously performed prior to radiofrequency catheter ablation
  • Patients in the subject group vulnerable to clinical study
  • Patients who had undergone a prior catheter ablation for atrial fibrillation

Sites / Locations

  • Keimyung University Dongsan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Impedance Guided Ablation Group

Contact Forced Guided Ablation Group

Arm Description

Impedance guided ablation group performs pulmonary vein(PV) isolation guided by annotation criteria with minimum time of 10 seconds, maximum range of 2 mm, and minimum impedance decrease over 5 Ohms instead of CF parameters. In the impedance guided group, operators are blinded to contact force data during PV isolation.

Contact force(CF) guided ablation group performs pulmonary vein (PV) isolation guided by automated annotation criteria with minimum time of 10 seconds, maximum range of 2mm, CF over time of 50% and minimum CF of 10 g.

Outcomes

Primary Outcome Measures

Acute success rate of pulmonary vein isolation obtained after initial circumferential ablation line around pulmonary veins
Acute success is defined as confirmation of entrance block in all pulmonary veins

Secondary Outcome Measures

Recurrence of any atrial arrhythmias (atrial fibrillation or atrial tachycardia)
Procedure time
Ablation time
Average contact force of each ablation lesion
Impedance drop of each ablation lesion
Force time integral of each ablation lesion

Full Information

First Posted
January 30, 2015
Last Updated
August 16, 2017
Sponsor
Keimyung University Dongsan Medical Center
Collaborators
Biosense Webster, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02364401
Brief Title
Impedance vs. Contact Force Guided Atrial Fibrillation Ablation Using Automated Annotation System
Official Title
Comparison of Efficacy Between Impedance Guided and Contact Force Guided Atrial Fibrillation Ablation Using Automated Annotation System
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
November 15, 2016 (Actual)
Study Completion Date
December 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Keimyung University Dongsan Medical Center
Collaborators
Biosense Webster, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the efficacy of catheter ablation for atrial fibrillation between contact force-guided and impedance-guided annotation using automated annotation system (Visitag™). Patients who receive atrial fibrillation ablation are randomly assigned in the same number to two groups with impedance guided ablation and contact force guided ablation using contact force sensing catheter (THERMOCOOL® SMARTTOUCH™ catheter, Biosense Webster, Inc., Diamond Bar, CA).
Detailed Description
During atrial fibrillation ablation, the location where ablation is conducted is displayed through annotation tags using 3D system to recognize energy delivery is done at the area. However this annotation method was unable to identify how effectively the ablation is done. To remedy this disadvantage, automated annotation system (VisiTag™ module, Biosense Webster, Inc., Diamond Bar, CA) was recently developed to make an automatic annotation when all pre-defined criteria are satisfied. But study on the clinical effects of this system is insufficient. The purpose of this study is to compare the efficacy of catheter ablation for atrial fibrillation between contact force-guided and impedance-guided annotation using automated annotation system.

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Impedance Guided Ablation Group
Arm Type
Experimental
Arm Description
Impedance guided ablation group performs pulmonary vein(PV) isolation guided by annotation criteria with minimum time of 10 seconds, maximum range of 2 mm, and minimum impedance decrease over 5 Ohms instead of CF parameters. In the impedance guided group, operators are blinded to contact force data during PV isolation.
Arm Title
Contact Forced Guided Ablation Group
Arm Type
Active Comparator
Arm Description
Contact force(CF) guided ablation group performs pulmonary vein (PV) isolation guided by automated annotation criteria with minimum time of 10 seconds, maximum range of 2mm, CF over time of 50% and minimum CF of 10 g.
Intervention Type
Device
Intervention Name(s)
Ablation
Other Intervention Name(s)
THERMOCOOL® SMARTTOUCH™ catheter
Intervention Description
Catheter ablation for atrial fibrillation
Primary Outcome Measure Information:
Title
Acute success rate of pulmonary vein isolation obtained after initial circumferential ablation line around pulmonary veins
Description
Acute success is defined as confirmation of entrance block in all pulmonary veins
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Recurrence of any atrial arrhythmias (atrial fibrillation or atrial tachycardia)
Time Frame
12 months
Title
Procedure time
Time Frame
6 hours
Title
Ablation time
Time Frame
6 hours
Title
Average contact force of each ablation lesion
Time Frame
6 hours
Title
Impedance drop of each ablation lesion
Time Frame
6 hours
Title
Force time integral of each ablation lesion
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with non-valvular atrial fibrillation Patients having atrial fibrillation even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks Patients with tachycardia-bradycardia syndrome associated with atrial fibrillation. Patients who can understand the information sheet and consent form on the need and procedure of catheter ablation and submitted them Patients who are available of follow-up at least for more than three months after catheter ablation Exclusion Criteria: Patients unsuitable for catheter ablation because the size of left atrium is over 5.5cm Patients unsuitable for catheter ablation due to previous history of pulmonary surgery or structural heat disease. Patients who cannot receive standard treatments such as anticoagulation therapy which need to be continuously performed prior to radiofrequency catheter ablation Patients in the subject group vulnerable to clinical study Patients who had undergone a prior catheter ablation for atrial fibrillation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyoung-Seob Park, MD
Organizational Affiliation
Keimyung University Dongsan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of

12. IPD Sharing Statement

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Impedance vs. Contact Force Guided Atrial Fibrillation Ablation Using Automated Annotation System

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