Atrial Fibrillation
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of additional ablation targeting complex fractionated atrial electrogram area within low voltage zone identified by high resolution mapping in patients with persistent atrial fibrillation.
Detailed description
Fifty patients with persistent atrial fibrillation will be randomized a 1:1 ratio to each group. A test group includes those who undergoing ablation targeting low voltage areas which contains complex fractionated trial electrogram in addition to pulmonary vein isolation and a control group includes who undergoing pulmonary vein isolation only.
Interventions
PROCEDUREpulmonary vein isolation
pulmonary vein isolation is conducted on the junction between the left atrium and pulmonary vein
PROCEDURELow-Voltage & CFAE guided ablation
In CFAE guided ablation,. Within low voltage zone, CFAE areas defined by shortest SCI and high ICL are identified.-Areas with the shortest SCI and high ICL within low voltage areas should be targeted first, followed by longer SCI regions (up to 120ms). Radiofrequency energy is delivered at target sites for 30-60 sec until the local electrogram is completely eliminated.
Sponsors
Biosense Webster, Inc.
Keimyung University Dongsan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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 atrial fibrillation 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 |
|---|---|---|
| Complication rate | 12 months | Compare complication rate between two groups |
| Total procedure time, ablation time and fluoroscopy time | 12 months | Compare total procedure time, ablation time and fluoroscopy time between two groups |
Countries
South Korea
Outcome results
None listed