Atrial Fibrillation Clinical Trial
— PRIME-AFOfficial title:
Prospective, Multicenter, Non-randomized Observational Registry Conducted at High Volume Experienced Treatment Centers Utilizing the Most Current AF Ablation Techniques.
Verified date | January 2022 |
Source | Erasmus Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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
Status | Active, not recruiting |
Enrollment | 212 |
Est. completion date | June 30, 2022 |
Est. primary completion date | June 9, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Ziekenhuis Netwerk Antwerpen | Antwerp | |
Netherlands | Erasmus MC | Rotterdam | |
Russian Federation | E. Meshalkin National medical research center | Novosibirsk |
Lead Sponsor | Collaborator |
---|---|
Erasmus Medical Center |
Belgium, Netherlands, Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Procedure time | Procedure time (minutes) | During ablation procedure | |
Primary | Fluoroscopy time | Fluoroscopy time (minutes) | During ablation procedure | |
Primary | Transseptal time | Transseptal time (time from insertion of catheters until transseptal puncture) (minutes) | During ablation procedure | |
Primary | Left atrial dwell time | Left atrial dwell time (time from LA entry until removal of catheters) (minutes) | During ablation procedure | |
Primary | PVI ablation time | PVI ablation time (total PVI ablation time, i.e. first until last application) (minutes) | During ablation procedure | |
Primary | Ablation time per pulmonary vein | Ablation time per pulmonary vein (minutes) | During ablation procedure | |
Secondary | First Pass Isolation | First Pass Isolation (i.e. Successful isolation of PVs after the first ablation attempt) | During ablation procedure | |
Secondary | Acute success | Acute success (Successful electrical isolation of PVs at the end of procedure) | During ablation procedure | |
Secondary | TouchUp rates | TouchUp rates (additional applications for successful PV isolation) | During ablation procedure | |
Secondary | Long-term success | Long-term success (freedom of atrial fibrillation 12 months after ablation) | From the date of procedure until 1 year | |
Secondary | Procedure-related adverse-events | Procedure-related adverse-events | From the date of procedure until 7 days | |
Secondary | Long-term adverse events | Long-term adverse events | From the date of procedure until 1 year |
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