Back to resultsEffect of Cavotricuspid Isthmus Ablation in Patients Without History of Typical Flutter During Ablation
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
cavotricuspid isthmus ablation
control group
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Fibrillation, Catheter ablation
Eligibility Criteria
Inclusion Criteria:
- Scheduled ablation for paroxysmal atrial fibrillation
Exclusion Criteria:
- Typical atrial flutter
- History of artificial tricuspid valve surgery
Sites / Locations
- Seoul st. mary's hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
cavotricuspid isthmus ablation
control group
Arm Description
Isthmus ablation was performed in paroxysmal atrial fibrillation patients.
Control group was performed no additional cavotricuspid isthmus ablation.
Outcomes
Primary Outcome Measures
Freedom of AF and Af
1 month, 3 months and 12months after ablation follow up visit and Check the recurrence of atrial fibrillation through EKG,Holter, event recording
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02031705
Brief Title
Effect of Cavotricuspid Isthmus Ablation in Patients Without History of Typical Flutter During Ablation
Official Title
Effect of Cavotricuspid Isthmus Ablation in Patients Without History of Typical Flutter During Ablation for Paroxysmal Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yong Seog Oh
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
It has been demonstrated that successful cavotricuspid isthmus ablation may be effective in preventing paroxysmal atrial fibrillation. However, the effectiveness of only isthmus ablation on atrial fibrillation itself is unclear.
Detailed Description
Researchers hypothesized that an organized activation pattern around the tricuspid annulus during atrial fibrillation indicated a mother reentrant circuit that could be terminated by a cavocaval isthmus ablation, thus preventing atrial fibrillation. The objectives of the present study were to evaluate the effectiveness of isthmus ablation in preventing atrial fibrillation and to identify predictors of its success.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
Fibrillation, Catheter ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
486 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cavotricuspid isthmus ablation
Arm Type
Active Comparator
Arm Description
Isthmus ablation was performed in paroxysmal atrial fibrillation patients.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Control group was performed no additional cavotricuspid isthmus ablation.
Intervention Type
Procedure
Intervention Name(s)
cavotricuspid isthmus ablation
Intervention Description
Isthmus ablation was performed in paroxysmal atrial fibrillation patients.
Intervention Type
Procedure
Intervention Name(s)
control group
Intervention Description
Control group was performed no additional cavotricuspid isthmus ablation.
Primary Outcome Measure Information:
Title
Freedom of AF and Af
Description
1 month, 3 months and 12months after ablation follow up visit and Check the recurrence of atrial fibrillation through EKG,Holter, event recording
Time Frame
1 year after catheter ablation
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Scheduled ablation for paroxysmal atrial fibrillation
Exclusion Criteria:
Typical atrial flutter
History of artificial tricuspid valve surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SungHwan Kim, MD
Phone
82-2-2258-1141
Email
sunghwan@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SungHwan Kim, MD
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul st. mary's hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SungHwan Kim, MD
Phone
82-2-2258-1141
Email
sunghwan@catholic.ac.kr
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33150753
Citation
Kim SH, Oh YS, Choi Y, Hwang Y, Kim JY, Kim TS, Kim JH, Jang SW, Lee MY, Joung B, Choi KJ. Long-Term Efficacy of Prophylactic Cavotricuspid Isthmus Ablation during Atrial Fibrillation Ablation in Patients Without Typical Atrial Flutter: a Prospective, Multicentre, Randomized Trial. Korean Circ J. 2021 Jan;51(1):58-64. doi: 10.4070/kcj.2020.0174. Epub 2020 Sep 14.
Results Reference
derived
Learn more about this trial
Effect of Cavotricuspid Isthmus Ablation in Patients Without History of Typical Flutter During Ablation
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