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Clinical Trials in Spain / NCT06656884
Active, not recruiting Observational

FARAPULSE Workflow Assessment Registry

NCT06656884 · tracked via the Priya Life Science Spain tracker
Sponsor
Boston Scientific Corporation
Phase
Observational
Started
2025-05-06
Last updated
2026-09-24

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
No
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)

FacilityCityRegionStatus
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

More Boston Scientific Corporation trials in Spain

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 Active, not recruiting
Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature Recruiting
A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation Active, not recruiting
Deep Brain Stimulation (DBS) Retrospective Outcomes Study Recruiting
OPTION-EMEA Clinical Trial Recruiting

Other trials for the same condition

A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation Active, not recruiting
Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration Recruiting
OPTION-EMEA Clinical Trial Recruiting
Monotherapy With P2Y12 Inhibitors in Patients With Atrial fIbrillation Undergoing Supraflex Stent Implantation Recruiting
Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants Recruiting
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 Spain