FARAPULSE Workflow Assessment Registry

Status: Recruiting
Location: See all (33) locations...
Study Type: Observational
SUMMARY

The study is designed to determine the best practices in the patient pathway, and to analyze pre-procedural, procedural and follow-up workflow data related with ablation of atrial fibrillation where the FARAPULSE™ Pulsed Field Ablation System is used in a commercial and standard of care setting. Workflow-related variables, inclusive of pre-procedural imaging, methods of transseptal access, anesthesia/sedation technique, intracardiac mapping, ablation settings, dosing strategy, lesion sets and general procedure management, will be used to identify predominant workflow schemes that will be associated with patient demographics, procedure-related complications (safety parameters), and one-year effectiveness parameters. The study data can be used for procedural workflow optimization when using Pulsed Field Ablation for the ablation treatment of Atrial Fibrillation based on patient demographics, cardiac anatomy and arrhythmia characteristics.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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

Locations
Other Locations
Austria
A.o. Krankenhaus der Elisabethinen Linz
RECRUITING
Linz
Belgium
Ziekenhuis aan de Stroom, Middelheim
RECRUITING
Antwerp
Ziekenhuis Oost-Limburg
RECRUITING
Genk
CHR de la Citadelle
RECRUITING
Namur
France
CHU de Bordeaux
NOT_YET_RECRUITING
Bordeaux
Hopital Saint Philibert
NOT_YET_RECRUITING
Lomme
CHRU Hopital Trousseau
RECRUITING
Tours
Germany
Universitaetsklinikum Dusseldorf
NOT_YET_RECRUITING
Düsseldorf
Universitaetsklinikum Heidelberg
NOT_YET_RECRUITING
Heidelberg
Staedtisches Klinikum Karlsruhe
RECRUITING
Karlsruhe
Munchen Klinik Bogenhausen
NOT_YET_RECRUITING
München
University Hospital of Muenster
WITHDRAWN
Münster
Greece
Ippokrateio General Hospital of Athens
NOT_YET_RECRUITING
Athens
Mitera Hospital
RECRUITING
Athens
Italy
Azienda Ospedaliero-Universitaria di Ferrara
RECRUITING
Ferrara
Ospedale Dell Angelo
NOT_YET_RECRUITING
Mestre
Azienda Ospedaliera San Gerardo
NOT_YET_RECRUITING
Monza
Ospedale di Rivoli
RECRUITING
Rivoli
Ospedale San Bortolo di Vicenza Azienda ULSS 8 Berica
RECRUITING
Vicenza
Netherlands
Onze Lieve Vrouwe Gasthuis
NOT_YET_RECRUITING
Amsterdam
Saudi Arabia
King Fahd Armed Forces Hospital
RECRUITING
Jeddah
Spain
Hospital De La Santa Creu I Sant Pau
RECRUITING
Barcelona
University Hospital Virgen Arrixaca
RECRUITING
El Palmar
Hospital de Navarra
RECRUITING
Pamplona
Hospital Universitario Nuestra Senora de Candelaria
RECRUITING
Santa Cruz De Tenerife
Sweden
GHP Arytmi Center Stockholm
NOT_YET_RECRUITING
Stockholm
United Kingdom
Blackpool Teaching Hospitals NHS Foundation Trust
WITHDRAWN
Blackpool
Royal Bournemouth Hospital
NOT_YET_RECRUITING
Bournemouth
Papworth Hospital
NOT_YET_RECRUITING
Cambridge
Glenfield Hospital
NOT_YET_RECRUITING
Leicester
St. Georges Hospital
NOT_YET_RECRUITING
London
Freeman Hospital
NOT_YET_RECRUITING
Newcastle Upon Tyne
Southampton University Hospital
NOT_YET_RECRUITING
Southampton
Contact Information
Primary
Hanneke Rombouts
hanneke.rombouts@bsci.com
0032 480 69 00 65
Time Frame
Start Date: 2025-05-06
Estimated Completion Date: 2027-02-15
Participants
Target number of participants: 500
Related Therapeutic Areas
Sponsors
Leads: Boston Scientific Corporation

This content was sourced from clinicaltrials.gov