Atrial Fibrillation
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of high density voltage and fractionation map guided ablation compared to anatomy-based circumferential pulmonary vein Isolation in patients with atrial fibrillation
Detailed description
In this study, a test group includes those who undergoing atrial fibrillation(AF) ablation guided by high density voltage and fractionation map. A control group will be chosen from database of patients who underwent AF ablation between 2018-2019. A control group includes the same number of consecutive patients who underwent anatomy-based circumferential pulmonary vein (PV) isolation.
Interventions
PROCEDUREAF ablation
AF ablation includes pulmonary vein isolation and/or voltage and fractionation guided ablation
Sponsors
Abbott
Keimyung University Dongsan Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Age over 20 years old and under 80 years old 2. Patients with non-valvular atrial fibrillation 3. Patients having AF even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks 4. Patients who can understand the information sheet and consent form on the need and procedure of catheter ablation and submitted them 5. Patients who are available of follow-up at least for more than three months after catheter ablation
Exclusion criteria
1. Patients unsuitable for catheter ablation because the size of left atrium is over 6.0 cm 2. Patients unsuitable for catheter ablation due to previous history of pulmonary surgery or structural heat disease. 3. Patients who cannot receive standard treatments such as anticoagulation therapy which need to be continuously performed prior to radiofrequency catheter ablation 4. Patients in the subject group vulnerable to clinical study 5. Patients who had undergone a prior catheter ablation for atrial fibrillation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Free from atrial arrhythmia at 12 months | 12 months | Freedom from any atrial arrhythmia lasting longer than 30 seconds during 1 year follow-up after single ablation with or without the use of antiarrhythmic medications with the exclusion of the 3-month blanking period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute AF termination rate during the procedure | During the procedure | Acute AF termination rate during the procedure |
| Complication rate | 12 months | Compare complication rate between two groups |
| Total procedure time, ablation time, fluoroscopy time | 12 months | Total procedure time, ablation time, fluoroscopy time between two groups |
Countries
South Korea
Contacts
Primary ContactHyoung-Seob Park, MD
Outcome results
None listed