Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
212 participants
OBSERVATIONAL
2018-10-31
2022-06-30
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Manual guided RF ablation
Patients with paroxysmal atrial fibrillation treated with Manual guided RF ablation using Contact Force catheters
No interventions assigned to this group
Cryoballoon ablation
Patients with paroxysmal atrial fibrillation treated with Cryoballoon ablation. Cryoballoon: Arctic Front Advance, Medtronic - 28 mm
No interventions assigned to this group
RMN guided RF ablation - High power
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.
No interventions assigned to this group
RMN guided RF ablation - Low power
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Erasmus Medical Center
OTHER
Responsible Party
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Anne-Marie Noten
Principal investigator
Locations
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Ziekenhuis Netwerk Antwerpen
Antwerp, , Belgium
Erasmus MC
Rotterdam, , Netherlands
E. Meshalkin National medical research center
Novosibirsk, , Russia
Countries
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Other Identifiers
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PRIME-AF
Identifier Type: -
Identifier Source: org_study_id
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