Persistent Atrial Fibrillation
Conditions
Keywords
persistent atrial fibrillation, remote magnetic navigation, cryoablation
Brief summary
Compare the safety and efficacy of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation.
Detailed description
1. Compare the efficacy of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation. 2. Compare the safety of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation. 3. Compare the procedural parameters of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation. 4. Compare the effects of amiodarone on recurrence after these two different ablation procedures.
Interventions
PROCEDURERemote magnetic navigation
Pulmonary vein isolation and other areas ablation guided by remote magnetic navigation
PROCEDURECryoablation
Pulmonary vein isolation and other areas ablation used by cryoballoon
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Persistent atrial fibrillation (\>7d, \< 5years) 2. Age 18-75 years 3. Patient is mentally and linguistically able to understand the aim of the trial and to show sufficient compliance in following the trial protocol
Exclusion criteria
1. Any previous left atrial ablation or surgery 2. Any cardiac surgery or percutaneous coronary intervention within 3 months prior to enrollment 3. Stroke or transient ischemic attack within 6 months prior to enrollment 4. Myocardial infarction within 3 months prior to enrollment 5. Anteroposterior left atrial diameter \> 55 mm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical efficacy (time to first AF recurrence after blanking period) | one year | the time to first AF recurrence after blanking period (month) |
| Clinical safety (Any procedure-related complications) | one year | Any procedure-related complications |
Secondary
| Measure | Time frame |
|---|---|
| Procedure time (min) | one week |
| Time to first cardiovascular hospitalization (month) | one year |
| QoL of 12 months (Units on a Scale) | one year |
| X-ray time (min) | one week |
Outcome results
None listed