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

Launched by BOSTON SCIENTIFIC CORPORATION · Jan 29, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for a heart condition called atrial fibrillation, which causes an irregular heartbeat. The study will collect information about the safety and effectiveness of a specific procedure that uses the FARAPULSE™ Pulsed Field Ablation System, along with a special mapping system and catheter. Researchers want to understand how well this method works and if it leads to any complications during and after the procedure, over a period of one year.

To be eligible for this trial, participants should be at least 18 years old and are expected to receive the FARAPULSE treatment as recommended by their doctor. They will need to be able to give their consent to participate and be treated at a participating clinical center. Importantly, individuals who are involved in other research studies that overlap with this one won't be able to join. If someone joins this trial, they can expect to undergo the ablation procedure and contribute to valuable research aimed at improving treatment for atrial fibrillation.

Gender

ALL

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