Clinical trial NCT06656884: FARAPULSE Workflow Assessment Registry
Official title: FARAPULSE Workflow Assessment Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation (AF)
Keywords: Catheter Ablation
Pulsed Field Ablation
FARAPULSE
Workflow Assessment
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2024-10-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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 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

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
* Prior Left Atrium Ablation

Primary outcomes:
measure: Association of patient demographics with Index procedure Workflow-related variables
timeFrame: Index Procedure
measure: Association of safety parameters with Index procedure Workflow-related variables
timeFrame: 12 months
measure: Association of effectiveness parameters with Index procedure Workflow-related variables
timeFrame: 12 months
measure: Association of patient demographics with effectiveness parameters
timeFrame: 12 months
measure: Association of patient demographics with safety parameters
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: A.o. Krankenhaus der Elisabethinen Linz
city: Antwerp
country: Belgium
facility: Ziekenhuis aan de Stroom, Middelheim
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Namur
country: Belgium
facility: CHR de la Citadelle
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Lomme
country: France
facility: Hopital Saint Philibert
city: Tours
country: France
facility: CHRU Hopital Trousseau
city: Düsseldorf
country: Germany
facility: Universitaetsklinikum Dusseldorf
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Karlsruhe
country: Germany
facility: Staedtisches Klinikum Karlsruhe
city: Münster
country: Germany
facility: University Hospital of Muenster
city: Athens
country: Greece
facility: Ippokrateio General Hospital of Athens
city: Athens
country: Greece
facility: Mitera Hospital
city: Ferrara
country: Italy
facility: Azienda Ospedaliero-Universitaria di Ferrara
city: Mestre
country: Italy
facility: Ospedale Dell Angelo
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerardo
city: Rivoli
country: Italy
facility: Ospedale di Rivoli
city: Vicenza
country: Italy
facility: Ospedale San Bortolo di Vicenza Azienda ULSS 8 Berica
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Jeddah
country: Saudi Arabia
facility: King Fahd Armed Forces Hospital
city: Barcelona
country: Spain
facility: Hospital De La Santa Creu I Sant Pau
city: El Palmar
country: Spain
facility: University Hospital Virgen Arrixaca
city: Pamplona
country: Spain
facility: Hospital de Navarra
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario Nuestra Senora de Candelaria
city: Stockholm
country: Sweden
facility: GHP Arytmi Center Stockholm
city: Blackpool
country: United Kingdom
facility: Blackpool Teaching Hospitals NHS Foundation Trust
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
city: London
country: United Kingdom
facility: St. Georges Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Southampton
country: United Kingdom
facility: Southampton University Hospital
Study officials:
References: