Status:
ACTIVE_NOT_RECRUITING
A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Atrial Fibrillation
Pulsed Field Ablation
Eligibility:
All Genders
18+ years
Brief Summary
The study is designed to collect data on the acute and long-term (1 year) safety and effectiveness outcome when an ablation procedure is performed in a commercial and standard of care setting with the...
Eligibility Criteria
Inclusion Criteria:
- Subjects are prospectively planned and intended to be treated with the FARAPULSE™ Pulsed Field Ablation system for cardiac tissue ablation, per physician's medical judgement, and as per hospitals' standard of care
- Subjects who are willing and capable of providing informed consent
- Subjects who are willing and capable of participating to this Registry at an approved clinical investigational center
- Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law
- Subjects are planned to undergo an ablation procedure whereby the FARAWAVE NAV PF Ablation Catheter is used in conjunction with the OPAL HDx Mapping System.
Exclusion Criteria:
- Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study. Exceptions are when the subject is participating in a mandatory governmental registry, or a purely observational registry, that do not interfere with the current study
Key Trial Info
Start Date :
July 30 2025
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2027
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT06808217
Start Date
July 30 2025
End Date
April 1 2027
Last Update
April 14 2026
Active Locations (22)
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1
Allgemeines Krankenhaus AKH
Vienna, Austria
2
CHRU de Clermont-Ferrand
Clermont-Ferrand, France
3
CHU Grenoble
Grenoble, France
4
Hospital de la Pitie-Salpetriere
Paris, France