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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

NCT06808217 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 550

Last updated 2026-05-20

No results posted yet for this study

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 FARAPULSE™ Pulsed Field Ablation System, whereby the FARAWAVE NAV Ablation catheter is used in conjunction with the OPAL HDx Mapping System. In addition, the study intends to analyse the association between several workflow-related variables, inclusive of intracardiac electro-anatomical mapping and ablation strategy with procedure-related complications (safety parameters), and one-year effectiveness parameters.

Conditions

Interventions

DEVICE

FARAPULSE Pulsed Field Ablation System

Subjects who have provided written informed consent are considered enrolled. Subjects who have received ablation treatment with the FARAPULSE™ System are assigned to the 'TREATMENT' group.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-30
Primary Completion
2027-04-01
Completion
2027-04-01

Countries

  • Austria
  • France
  • Germany
  • Greece
  • Ireland
  • Italy
  • Monaco
  • Netherlands
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06808217 on ClinicalTrials.gov