Atrial Fibrillation, Catheter Ablation
Conditions
Keywords
Paroxysmal Atrial Fibrillation, Catheter Ablation, Cryoballoon, Radiofrequency ablation, Remote Magnetic Navigation
Brief summary
The purpose of this observational registry is to prospectively collect procedure efficiency, safety and acute and long term outcome data from catheter ablation procedures as treatment of paroxysmal atrial fibrillation, using the following treatment modalities: * Cryoballoon ablation * Manual guided RF ablation using Contact Force catheters * Remote Magnetic Navigation guided RF ablation with e-Contact and high power settings * Remote Magnetic Navigation guided RF ablation with e-Contact and low power settings
Interventions
None listed
Sponsors
Erasmus Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented Paroxysmal Atrial Fibrillation * Eligibility for Pulmonary Vein Isolation by catheter ablation based on the respective ACC/AHA/ESC Guideline valid at the date of procedure * Signed the informed consent to participate in the registry
Exclusion criteria
* Younger than 18 years of age * Prior AF ablation procedure (including MAZE procedure) * Prior ablation of Non-AF Arrhythmia within 3 months of enrollment * Presence of cardiac thrombus * Other AF ablations performed during procedure (e.g. lines, rotor, CFAE's etc) * Active endocarditis or systemic infection * Life expectancy \< 1 year * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure time | During ablation procedure | Procedure time (minutes) |
| Fluoroscopy time | During ablation procedure | Fluoroscopy time (minutes) |
| Transseptal time | During ablation procedure | Transseptal time (time from insertion of catheters until transseptal puncture) (minutes) |
| Left atrial dwell time | During ablation procedure | Left atrial dwell time (time from LA entry until removal of catheters) (minutes) |
| PVI ablation time | During ablation procedure | PVI ablation time (total PVI ablation time, i.e. first until last application) (minutes) |
| Ablation time per pulmonary vein | During ablation procedure | Ablation time per pulmonary vein (minutes) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| First Pass Isolation | During ablation procedure | First Pass Isolation (i.e. Successful isolation of PVs after the first ablation attempt) |
| Acute success | During ablation procedure | Acute success (Successful electrical isolation of PVs at the end of procedure) |
| TouchUp rates | During ablation procedure | TouchUp rates (additional applications for successful PV isolation) |
| Long-term success | From the date of procedure until 1 year | Long-term success (freedom of atrial fibrillation 12 months after ablation) |
| Procedure-related adverse-events | From the date of procedure until 7 days | Procedure-related adverse-events |
| Long-term adverse events | From the date of procedure until 1 year | Long-term adverse events |
Countries
Belgium, Netherlands, Russia
Outcome results
None listed