Persistent Atrial Fibrillation
Conditions
Keywords
Persistent Atrial Fibrillation, Linear ablation, Catheter ablation, Contact force
Brief summary
Linear ablation is frequently used in the procedure for persistent atrial fibrillation. However, it has a limitation because of technical difficulty. Incomplete block is common and an important cause of atrial tachycardia. The association between contact force values and successful linear block has not been revealed yet. We aim to the effectiveness and safety of linear ablation by using CF sensing catheter.
Detailed description
Catheter ablation is currently accepted as a treatment option for symptomatic atrial fibrillation. Linear ablation is frequently used in the procedure for persistent atrial fibrillation. Multiple studies have shown benefit of linear ablation. However, it has a limitation because of technical difficulty. Incomplete block is common and an important cause of atrial tachycardia. Contact-force (CF) monitoring during procedure has recently been available. This technology appears to significantly decrease procedure time and short term reconnection incidence in pulmonary vein (PV) isolation. It also helped to resolve the cause of PV reconnection. Some reports demonstrated that the association between reconnection and lower CF value. Linear ablation has more variation to interrupt block and reconnection was more often than PV isolation. The association between CF values and successful linear block has not been revealed yet. In addition, the investigators aim to the effectiveness and safety of linear ablation by using CF sensing catheter.
Interventions
PROCEDUREPulmonary vein isolation
A pulmonary vein isolation procedure will be performed using radiofrequency ablation with contact force monitoring.
PROCEDUREContact force assisted left atrial linear ablation
Left atrial linear ablation (Roof line and Anterior line) after pulmonary vein isolation during catheter ablation for persistent atrial fibrillation monitoring contact force.
PROCEDUREleft atrial linear ablation without contact force monitoring
Left atrial linear ablation (Roof line and Anterior line) after pulmonary vein isolation during catheter ablation for persistent atrial fibrillation without monitoring contact force.
Sponsors
Biosense Webster, Inc.
Korea University Anam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients age is18 years or greater * Patients with persistent AF (AF episode lasting \> 7 days) * Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication * Patients with recurrent or sustained arrhythmia after pulmonary vein isolation * Patients undergoing a first-time ablation procedure for AF * At least one episode of AF must have been documented by ECG, Holter, loop recorder, telemetry, trans telephonic monitoring (TTM), or implantable device within last 2 years of enrollment in this investigation * Patients must be able and willing to provide written informed consent to participate in this investigation
Exclusion criteria
* Patients with long-standing persistent AF; * Long-standing persistent AF will be defined as a sustained episode lasting more than 3 years. * Patients for whom cardioversion or sinus rhythm will never be attempted/pursued; * Patients with AF felt to be secondary to an obvious reversible cause * Patients with contraindications to systemic anticoagulation with heparin or warfarin or a direct thrombin inhibitor; * Patients with left atrial size ≥ 60 mm (2D echocardiography, parasternal long axis view) * Moderate to severe valvular disease * Reduced left ventricular function (ejection fraction \<40%) * Patients who are pregnant. Pregnancy will be assessed by patients informing the physicians.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from atrial fibrillation/atrial tachycardia | 12 months | Freedom from any documented episode of atrial fibrillation/atrial tachycardia occurring after a single ablation procedure and lasting longer than 30 seconds with/without antiarrhythmic medication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total radiofrequency energy | 12 months | Total radiofrequency energy to achieve bidirectional block of linear lesion in left atrium |
| Total force value | 12 months | Total force value for complete block of linear lesion |
Countries
South Korea
Contacts
Primary ContactSeung-Young Roh, MD
Backup ContactKwang No Lee, MD
Outcome results
None listed