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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Page 1 of 6 (22 locations)

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