Prospective, Multicenter, Non-randomized Observational Registry Conducted at High Volume Experienced Treatment Centers Utilizing the Most Current AF Ablation Techniques.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Erasmus Medical Center
- Enrollment
- 212
- Locations
- 3
- Primary Endpoint
- Fluoroscopy time
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Fluoroscopy time
Time Frame: During ablation procedure
Fluoroscopy time (minutes)
Left atrial dwell time
Time Frame: During ablation procedure
Left atrial dwell time (time from LA entry until removal of catheters) (minutes)
Transseptal time
Time Frame: During ablation procedure
Transseptal time (time from insertion of catheters until transseptal puncture) (minutes)
Ablation time per pulmonary vein
Time Frame: During ablation procedure
Ablation time per pulmonary vein (minutes)
PVI ablation time
Time Frame: During ablation procedure
PVI ablation time (total PVI ablation time, i.e. first until last application) (minutes)
Procedure time
Time Frame: During ablation procedure
Procedure time (minutes)
Secondary Outcomes
- First Pass Isolation(During ablation procedure)
- Acute success(During ablation procedure)
- Procedure-related adverse-events(From the date of procedure until 7 days)
- TouchUp rates(During ablation procedure)
- Long-term success(From the date of procedure until 1 year)
- Long-term adverse events(From the date of procedure until 1 year)
Investigators
Anne-Marie Noten
Principal investigator
Erasmus Medical Center