Clinical trial NCT06808217: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atrial Fibrillation
Pulsed Field Ablation
FARAPULSE
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2025-02-05
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 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 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
* 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

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: 12 months
measure: Primary effectiveness Endpoint
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Allgemeines Krankenhaus AKH
city: Grenoble
country: France
facility: CHU Grenoble
city: Toulouse
country: France
facility: Clinique Pasteur
city: Frankfurt
country: Germany
facility: Cardioangiologisches Centrum Bethanien
city: Athens
country: Greece
facility: Henry Dunant Hospital Center
city: Piacenza
country: Italy
facility: Ospedale Civile Di Piacenza
city: Monaco
country: Monaco
facility: Centre Hospitalier Princesse Grace
city: Rotterdam
country: Netherlands
facility: Eramus MC- University Medical Center
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
Study officials:
References: