FARAPULSE Workflow Assessment Registry

NCT06656884 · tracked via the Priya Life Science UK tracker

Sponsor

Boston Scientific Corporation

Phase

Observational

Started

2025-05-06

Last updated

2026-08-28

Condition(s) studied

Atrial Fibrillation (AF)

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 outcome measure(s)

Association of patient demographics with Index procedure Workflow-related variables — Index Procedure
Patient demographics such as age (years), gender, BMI (kg/m²), different comorbidities, LA Volume (ml), PV anatomy, AF type, pre-procedural AF management) will be compared with different index procedure workflow related variables such as pre-procedural imaging, method and location of transseptal access, intracardiac electro-anatomical mapping, imaging techniques, anesthesia/sedation technique, ablation settings, dosing strategy, lesion sets and general procedure management
Association of safety parameters with Index procedure Workflow-related variables — 12 months
Safety parameters such as device or procedure related serious adverse events (within 7 days onset date) Death; Myocardial Infarction; Stroke; TIA; Peripheral or Organ Thromboembolism; Pulmonary Edema; Unresolved Phrenic Nerve Palsy/Paresis at 12 Months post-Index Procedure; Vascular Access Complications; Heart Block; Gastric Motility / Pyloric Spasm Disorders, Cardiac Tamponade / Perforation; Pericarditis; Severe Hemolysis with Subsequent Renal Injury or Significant Anemia / Within 12 Months onset date: Pulmonary Vein Stenosis; Atrio-Esophageal Fistula) will be compared with different index procedure workflow related variables such as pre-procedural imaging, method and location of transseptal access, intracardiac electro-anatomical mapping, imaging techniques, anesthesia/sedation technique, ablation settings, dosing strategy, lesion sets and general procedure management
Association of effectiveness parameters with Index procedure Workflow-related variables — 12 months
Acute and long-term (freedom from AF episodes and freedom from intervention for AF/AFL/AT) Effectiveness parameters will be compared with different index procedure workflow related variables such as pre-procedural imaging, method and location of transseptal access, intracardiac electro-anatomical mapping, imaging techniques, anesthesia/sedation technique, ablation settings, dosing strategy, lesion sets and general procedure management
Association of patient demographics with effectiveness parameters — 12 months
Patient demographics such as age (years), gender, BMI (kg/m²), different comorbidities, LA Volume (ml), PV anatomy, AF type, pre-procedural AF management) will be compared with Acute and long-term (freedom from AF episodes and freedom from intervention for AF/AFL/AT) Effectiveness parameters
Association of patient demographics with safety parameters — 12 months
Patient demographics such as age (years), gender, BMI (kg/m²), different comorbidities, LA Volume (ml), PV anatomy, AF type, pre-procedural AF management) will be compared with Safety parameters such as device or procedure related serious adverse events (within 7 days onset date) Death; Myocardial Infarction; Stroke; TIA; Peripheral or Organ Thromboembolism; Pulmonary Edema; Unresolved Phrenic Nerve Palsy/Paresis at 12 Months post-Index Procedure; Vascular Access Complications; Heart Block; Gastric Motility / Pyloric Spasm Disorders, Cardiac Tamponade / Perforation; Pericarditis; Severe Hemolysis with Subsequent Renal Injury or Significant Anemia / Within 12 Months onset date: Pulmonary Vein Stenosis; Atrio-Esophageal Fistula)

Trial sites (28)

Facility	City	Region
A.o. Krankenhaus der Elisabethinen Linz	Linz	Austria
Ziekenhuis aan de Stroom, Middelheim	Antwerp	Belgium
Ziekenhuis Oost-Limburg	Genk	Belgium
CHR de la Citadelle	Namur	Belgium
CHU de Bordeaux	Bordeaux	France
Hopital Saint Philibert	Lomme	France
CHRU Hopital Trousseau	Tours	France
Universitaetsklinikum Dusseldorf	Düsseldorf	Germany
Staedtisches Klinikum Karlsruhe	Karlsruhe	Germany
Munchen Klinik Bogenhausen	München	Germany
Ippokrateio General Hospital of Athens	Athens	Greece
Mitera Hospital	Athens	Greece
Azienda Ospedaliero-Universitaria di Ferrara	Ferrara	Italy
Ospedale Dell Angelo	Mestre	Italy
Azienda Ospedaliera San Gerardo	Monza	Italy
Ospedale di Rivoli	Rivoli	Italy
Ospedale San Bortolo di Vicenza Azienda ULSS 8 Berica	Vicenza	Italy
King Fahd Armed Forces Hospital	Jeddah	Saudi Arabia
Hospital De La Santa Creu I Sant Pau	Barcelona	Spain
University Hospital Virgen Arrixaca	El Palmar	Spain
Hospital de Navarra	Pamplona	Spain
Hospital Universitario Nuestra Senora de Candelaria	Santa Cruz de Tenerife	Spain
GHP Arytmi Center Stockholm	Stockholm	Sweden
Royal Bournemouth Hospital	Bournemouth	United Kingdom
Papworth Hospital	Cambridge	United Kingdom
Glenfield Hospital	Leicester	United Kingdom
Freeman Hospital	Newcastle upon Tyne	United Kingdom
Southampton University Hospital	Southampton	United Kingdom

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06656884 on ClinicalTrials.gov ↗ ← All trials in the UK