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

Not yet recruiting

• Conditions: Atrial Fibrillation; Pulsed Field Ablation; FARAPULSE

• Registration Number: NCT06808217
• Lead Sponsor: Boston Scientific Corporation

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-01-29
• Study First Posted: 2025-02-05
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-17
• Last Update Posted: 2025-06-20
• Study Start: 2025-08-01
• Primary Completion: 2026-08-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint	12 months	The Primary Safety Endpoint is defined as the rate of device or procedure related serious adverse events following the index procedure through the 12 Month Follow-up
Primary effectiveness Endpoint	12 Months	The Primary Effectiveness Endpoint is defined as the rate of treatment success, which is defined by Acute and Chronic Procedural Success

Trial Locations

Locations (15)

Ippokrateio General Hospital; 🇬🇷 Thessaloníki, Greece

Maria Cecilia Hospital; 🇮🇹 Cotignola, Italy

Clinica Montevergine; 🇮🇹 Mercogliano, Italy

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego; 🇵🇱 Warsaw, Poland

Uniwersytecki Szpital Kliniczny Wrocławiu; 🇵🇱 Wrocław, Poland

Allgemeines Krankenhaus AKH; 🇦🇹 Wien, Austria

CHU Grenoble; 🇫🇷 Grenoble, France

Clinique Pasteur; 🇫🇷 Toulouse, France

Cardioangiologisches Centrum Bethanien; 🇩🇪 Frankfurt, Germany

Henry Dunant Hospital Center; 🇬🇷 Athens, Greece

Scroll for more (5 remaining)