Effect of Cavotricuspid Isthmus Ablation in Patients Without History of Typical Flutter During Ablation
1 other identifier
interventional
366
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 9, 2013
CompletedFirst Posted
Study publicly available on registry
January 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedApril 23, 2024
April 1, 2024
6.9 years
September 9, 2013
April 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
1 year after catheter ablation
Study Arms (2)
cavotricuspid isthmus ablation
ACTIVE COMPARATORIsthmus ablation was performed in paroxysmal atrial fibrillation patients.
control group
PLACEBO COMPARATORControl group was performed no additional cavotricuspid isthmus ablation.
Interventions
Isthmus ablation was performed in paroxysmal atrial fibrillation patients.
Control group was performed no additional cavotricuspid isthmus ablation.
Eligibility Criteria
You may qualify if:
- Scheduled ablation for paroxysmal atrial fibrillation
You may not qualify if:
- Typical atrial flutter
- History of artificial tricuspid valve surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yong Seog Ohlead
Study Sites (1)
Seoul st. mary's hospital
Seoul, South Korea
Related Publications (1)
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.
PMID: 33150753DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
SungHwan Kim, MD
Seoul St. Mary's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 9, 2013
First Posted
January 9, 2014
Study Start
July 1, 2012
Primary Completion
June 1, 2019
Study Completion
August 1, 2019
Last Updated
April 23, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share