An observational study in Atrial Fibrillation and Catheter Ablation, sponsored by Erasmus Medical Center. Status unknown at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-26.
Sponsored by Erasmus Medical Center · Observational
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:
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 212 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients eligible for participation in the study have a reported incidence of at least two documented episodes of symptomatic paroxysmal atrial fibrillation during the three months preceding trial entry, as well as documentation of at least one episode of AF on ECG, and are eligible for PVI by catheter ablation based on the respective ACC/AHA/ESC Guideline valid at the date of procedure
Exclusion Criteria:
Patients with paroxysmal atrial fibrillation treated with Manual guided RF ablation using Contact Force catheters
Patients with paroxysmal atrial fibrillation treated with Cryoballoon ablation. Cryoballoon: Arctic Front Advance, Medtronic - 28 mm
Patients with paroxysmal atrial fibrillation treated with Remote Magnetic Navigation guided RF ablation with e-Contact and high power settings. High power ablation settings: a minimum of 40 Watt, 43grC, flow 17ml/min. Higher voltages (e.g. anterior wall) are allowed with respect to the operators' preference.
Patients with paroxysmal atrial fibrillation treated with Remote Magnetic Navigation guided RF ablation with e-Contact and low power settings. Low power ablation settings: a maximum of 39 Watt, 43grC, flow 17ml/min. Lower voltages are allowed with respect to the operators' preference.
Procedure time
Procedure time (minutes)
Time frame: During ablation procedure
Fluoroscopy time
Fluoroscopy time (minutes)
Time frame: During ablation procedure
Transseptal time
Transseptal time (time from insertion of catheters until transseptal puncture) (minutes)
Time frame: During ablation procedure
Left atrial dwell time
Left atrial dwell time (time from LA entry until removal of catheters) (minutes)
Time frame: During ablation procedure
PVI ablation time
PVI ablation time (total PVI ablation time, i.e. first until last application) (minutes)
Time frame: During ablation procedure
Ablation time per pulmonary vein
Ablation time per pulmonary vein (minutes)
Time frame: During ablation procedure
First Pass Isolation
First Pass Isolation (i.e. Successful isolation of PVs after the first ablation attempt)
Time frame: During ablation procedure
Acute success
Acute success (Successful electrical isolation of PVs at the end of procedure)
Time frame: During ablation procedure
TouchUp rates
TouchUp rates (additional applications for successful PV isolation)
Time frame: During ablation procedure
Long-term success
Long-term success (freedom of atrial fibrillation 12 months after ablation)
Time frame: From the date of procedure until 1 year
Procedure-related adverse-events
Procedure-related adverse-events
Time frame: From the date of procedure until 7 days
Long-term adverse events
Long-term adverse events
Time frame: From the date of procedure until 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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