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 | Active Not Recruiting

• 1 other identifier: PF337
• Study Type: observational
• Target: 550
• Locations: 10 countries
• Sites: 22

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.

Conditions

Atrial Fibrillation; FARAPULSE; Pulsed Field Ablation

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint

  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

  12 months

• Primary effectiveness Endpoint

  The Primary Effectiveness Endpoint is defined as the rate of treatment success, which is defined by Acute and Chronic Procedural Success

  12 Months

Interventions

FARAPULSE Pulsed Field Ablation System DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

• Subjects who will undergo an ablation procedure with the FARAPULSE™ Pulsed Field Ablation system, per physician's medical judgement, and according to hospitals' standard of care.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (22)

Allgemeines Krankenhaus AKH

Vienna, Austria

Location

CHRU de Clermont-Ferrand

Clermont-Ferrand, France

Location

CHU Grenoble

Grenoble, France

Location

Hospital de la Pitie-Salpetriere

Paris, France

Location

Hospital Europeen Georges-Pompidou (HEGP)

Paris, France

Location

Centre Cardiologique du Nord

Saint-Denis, France

Location

CHU de Saint-Etienne

Saint-Priest-en-Jarez, France

Location

Clinique Pasteur

Toulouse, France

Location

Vivantes Klinikum Am Urban

Berlin, Germany

Location

MVZ CCB Frankfurt und Main-Taunus GbR

Frankfurt, Germany

Location

Asklepios Klinik Saint Georg

Hamburg, Germany

Location

Henry Dunant Hospital Center

Athens, Greece

Location

Ippokrateio General Hospital

Thessaloniki, Greece

Location

Mater Private Hospital

Dublin, Ireland

Location

Clinica Montevergine

Mercogliano, Italy

Location

Centre Hospitalier Princesse Grace

Monaco, Monaco

Location

Eramus MC- University Medical Center

Rotterdam, Netherlands

Location

Isala Klinieken

Zwolle, Netherlands

Location

Hospital de Basurto

Bilbao, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Cardiocentro Ticino

Lugano, Switzerland

Location

University Hospital Zurich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 5, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

GR (2); CH (2); IE (1); ES (2); FR (7); IT (1); MO (1); NL (2); DE (3); AU (1)