Back to resultsComparison of Single Groin and Single Trans-septal Puncture and Conventional Bilateral Groin Puncture and Double Trans-septal Puncture in Catheter Ablation for Atrial Fibrillation
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
single trans-septal puncture
conventional bilateral groin puncture
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Patients agreement of consent
- Patients who age more than 19
- patients who undergoing catheter ablation of atrial fibrillation
- Patients who are not vascular disease
Exclusion Criteria:
- patients who do not agree with study inclusion
- persistent AF
- Patients with vascular disease or venous anomaly
- Patients with structural abnormality of the heart
Sites / Locations
- Severance Cardiovascular Hospital, Yonsei University Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
single puncture group
conventional group
Arm Description
single trans-septal puncture
conventional bilateral groin puncture
Outcomes
Primary Outcome Measures
Patient's subjective discomfort
Secondary Outcome Measures
Procedure time
Procedure related complication rate
Long-term AF recurrence rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02438176
Brief Title
Comparison of Single Groin and Single Trans-septal Puncture and Conventional Bilateral Groin Puncture and Double Trans-septal Puncture in Catheter Ablation for Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 2, 2015 (undefined)
Primary Completion Date
March 9, 2018 (Actual)
Study Completion Date
March 9, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare single groin puncture and bilateral groin puncture during AF ablation procedure. The investigators will compare 1) the degree of patients' discomfort during hemostasis by questionaire, 2) procedure time, 3) complication rates, and 4) 1-year clinical recurrence rate of AF.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single puncture group
Arm Type
Experimental
Arm Description
single trans-septal puncture
Arm Title
conventional group
Arm Type
Active Comparator
Arm Description
conventional bilateral groin puncture
Intervention Type
Procedure
Intervention Name(s)
single trans-septal puncture
Intervention Description
The investigators will compare bilateral groin puncture AF ablation and single groin puncture AF ablation with 1:2 randomization.
Intervention Type
Procedure
Intervention Name(s)
conventional bilateral groin puncture
Intervention Description
Bilateral groin puncture AF ablation is control procedure exactly same to routine AF ablation with double trans-septal puncture.
Primary Outcome Measure Information:
Title
Patient's subjective discomfort
Time Frame
6month after procedure
Secondary Outcome Measure Information:
Title
Procedure time
Time Frame
1day
Title
Procedure related complication rate
Time Frame
1 month after procedure
Title
Long-term AF recurrence rate
Time Frame
12 month after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients agreement of consent
Patients who age more than 19
patients who undergoing catheter ablation of atrial fibrillation
Patients who are not vascular disease
Exclusion Criteria:
patients who do not agree with study inclusion
persistent AF
Patients with vascular disease or venous anomaly
Patients with structural abnormality of the heart
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
Comparison of Single Groin and Single Trans-septal Puncture and Conventional Bilateral Groin Puncture and Double Trans-septal Puncture in Catheter Ablation for Atrial Fibrillation
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