Assessment of workflow practices for atrial fibrillation treatment using FARAPULSE technology
FARAPULSE Workflow Assessment Registry
This study is testing how to improve the treatment process for atrial fibrillation using a new technology called FARAPULSE to see what works best for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston Scientific Corporation Industry-sponsored |
| Locations | 32 sites (Linz and 31 other locations) |
| Trial ID | NCT06656884 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate best practices in the patient pathway for atrial fibrillation treatment using the FARAPULSE™ Pulsed Field Ablation System. It will analyze various workflow data, including pre-procedural imaging, anesthesia techniques, and procedural management, to identify effective strategies associated with patient demographics and outcomes. The goal is to optimize procedural workflows based on collected data to enhance safety and effectiveness in treating atrial fibrillation.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are scheduled for treatment with the FARAPULSE™ system and can provide informed consent.
Not a fit: Patients currently enrolled in other investigational studies or those who have previously undergone left atrium ablation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes and safety for patients undergoing ablation for atrial fibrillation.
How similar studies have performed: While this study focuses on a specific technology and workflow assessment, similar studies in procedural optimization have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Linz and 31 other locations
- A.o. Krankenhaus der Elisabethinen Linz — Linz, Austria (Not_yet_recruiting)
- Ziekenhuis aan de Stroom, Middelheim — Antwerp, Belgium (Not_yet_recruiting)
- Ziekenhuis Oost-Limburg — Genk, Belgium (Not_yet_recruiting)
- CHR de la Citadelle — Namur, Belgium (Not_yet_recruiting)
- CHU de Bordeaux — Bordeaux, France (Not_yet_recruiting)
- Hopital Saint Philibert — Lomme, France (Not_yet_recruiting)
- CHRU Hopital Trousseau — Tours, France (Not_yet_recruiting)
- Universitaetsklinikum Dusseldorf — Düsseldorf, Germany (Not_yet_recruiting)
- Universitaetsklinikum Heidelberg — Heidelberg, Germany (Not_yet_recruiting)
- Staedtisches Klinikum Karlsruhe — Karlsruhe, Germany (Not_yet_recruiting)
- University Hospital of Muenster — Münster, Germany (Not_yet_recruiting)
- Ippokrateio General Hospital of Athens — Athens, Greece (Not_yet_recruiting)
- Mitera Hospital — Athens, Greece (Recruiting)
- Azienda Ospedaliero-Universitaria di Ferrara — Ferrara, Italy (Not_yet_recruiting)
- Ospedale Dell Angelo — Mestre, Italy (Not_yet_recruiting)
- Azienda Ospedaliera San Gerardo — Monza, Italy (Not_yet_recruiting)
- Ospedale di Rivoli — Rivoli, Italy (Not_yet_recruiting)
- Ospedale San Bortolo di Vicenza Azienda ULSS 8 Berica — Vicenza, Italy (Not_yet_recruiting)
- Onze Lieve Vrouwe Gasthuis — Amsterdam, Netherlands (Not_yet_recruiting)
- King Fahd Armed Forces Hospital — Jeddah, Saudi Arabia (Not_yet_recruiting)
- Hospital De La Santa Creu I Sant Pau — Barcelona, Spain (Not_yet_recruiting)
- University Hospital Virgen Arrixaca — El Palmar, Spain (Not_yet_recruiting)
- Hospital de Navarra — Pamplona, Spain (Recruiting)
- Hospital Universitario Nuestra Senora de Candelaria — Santa Cruz De Tenerife, Spain (Not_yet_recruiting)
- GHP Arytmi Center Stockholm — Stockholm, Sweden (Not_yet_recruiting)
- Blackpool Teaching Hospitals NHS Foundation Trust — Blackpool, United Kingdom (Not_yet_recruiting)
- Royal Bournemouth Hospital — Bournemouth, United Kingdom (Not_yet_recruiting)
- Papworth Hospital — Cambridge, United Kingdom (Not_yet_recruiting)
- Glenfield Hospital — Leicester, United Kingdom (Not_yet_recruiting)
- St. Georges Hospital — London, United Kingdom (Not_yet_recruiting)
- Freeman Hospital — Newcastle Upon Tyne, United Kingdom (Not_yet_recruiting)
- Southampton University Hospital — Southampton, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Nele Cielen, PhD
- Email: Nele.Cielen@bsci.com
- Phone: 0032 470 99 11 43
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.