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

Status: Recruiting
Location: See all (32) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• 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.

Locations
Other Locations
Austria
Allgemeines Krankenhaus AKH
NOT_YET_RECRUITING
Vienna
Croatia
Klinicki bolnicki centar Zagreb
NOT_YET_RECRUITING
Zagreb
France
CHRU de Clermont-Ferrand
RECRUITING
Clermont-ferrand
CHU Grenoble
RECRUITING
Grenoble
Hospital de la Pitie-Salpetriere
NOT_YET_RECRUITING
Paris
Hospital Europeen Georges-Pompidou (HEGP)
NOT_YET_RECRUITING
Paris
Centre Cardiologique du Nord
RECRUITING
Saint-denis
CHU de Saint-Etienne
NOT_YET_RECRUITING
Saint-priest-en-jarez
Clinique Pasteur
RECRUITING
Toulouse
Germany
Vivantes Klinikum Am Urban
NOT_YET_RECRUITING
Berlin
MVZ CCB Frankfurt und Main-Taunus GbR
NOT_YET_RECRUITING
Frankfurt
Asklepios Klinik Saint Georg
NOT_YET_RECRUITING
Hamburg
Greece
Henry Dunant Hospital Center
RECRUITING
Athens
Ippokrateio General Hospital
NOT_YET_RECRUITING
Thessaloniki
Ippokrateio General Hospital
NOT_YET_RECRUITING
Thessaloniki
Ireland
Mater Private Hospital
RECRUITING
Dublin
Italy
Maria Cecilia Hospital
NOT_YET_RECRUITING
Cotignola
Clinica Montevergine
NOT_YET_RECRUITING
Mercogliano
Ospedale Civile Di Piacenza
NOT_YET_RECRUITING
Piacenza
Kuwait
Sheikh Jaber Al Ahmad Hospital
NOT_YET_RECRUITING
Kuwait City
Monaco
Centre Hospitalier Princesse Grace
RECRUITING
Monaco
Netherlands
Eramus MC- University Medical Center
RECRUITING
Rotterdam
Isala Klinieken
NOT_YET_RECRUITING
Zwolle
Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
NOT_YET_RECRUITING
Warsaw
Uniwersytecki Szpital Kliniczny Wrocławiu
NOT_YET_RECRUITING
Wroclaw
Saudi Arabia
National Guard Hospital
NOT_YET_RECRUITING
Riyadh
Spain
Hospital de Basurto
NOT_YET_RECRUITING
Bilbao
Hospital Clinico San Carlos
RECRUITING
Madrid
Hospital Universitario Marques de Valdecilla
NOT_YET_RECRUITING
Santander
Switzerland
Cardiocentro Ticino
NOT_YET_RECRUITING
Lugano
University Hospital Zurich
NOT_YET_RECRUITING
Zurich
United Kingdom
Cleveland Clinic London
NOT_YET_RECRUITING
London
Contact Information
Primary
Hanneke Rombouts
hanneke.rombouts@bsci.com
0032 480 69 00 65
Time Frame
Start Date: 2025-07-30
Estimated Completion Date: 2027-08-01
Participants
Target number of participants: 500
Related Therapeutic Areas
Sponsors
Leads: Boston Scientific Corporation

This content was sourced from clinicaltrials.gov