FARAPULSE Workflow Assessment Registry

NCT06656884 | Active Not Recruiting

• 1 other identifier: PF117
• Study Type: observational
• Target: 524
• Locations: 10 countries
• Sites: 28

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.

Conditions

Atrial Fibrillation (AF)

Keywords

Catheter Ablation; Pulsed Field Ablation; FARAPULSE; Workflow Assessment

Outcome Measures

Primary Outcomes (5)

• Association of patient demographics with Index procedure Workflow-related variables

  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

  Index Procedure

• Association of safety parameters with Index procedure Workflow-related variables

  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

  12 months

• Association of effectiveness parameters with Index procedure Workflow-related variables

  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

  12 months

• Association of patient demographics with effectiveness parameters

  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

  12 months

• Association of patient demographics with safety parameters

  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)

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (28)

A.o. Krankenhaus der Elisabethinen Linz

Linz, Austria

Location

Ziekenhuis aan de Stroom, Middelheim

Antwerp, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, Belgium

Location

CHR de la Citadelle

Namur, Belgium

Location

CHU de Bordeaux

Bordeaux, France

Location

Hopital Saint Philibert

Lomme, France

Location

CHRU Hopital Trousseau

Tours, France

Location

Universitaetsklinikum Dusseldorf

Düsseldorf, Germany

Location

Staedtisches Klinikum Karlsruhe

Karlsruhe, Germany

Location

Munchen Klinik Bogenhausen

München, Germany

Location

Ippokrateio General Hospital of Athens

Athens, Greece

Location

Mitera Hospital

Athens, Greece

Location

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, Italy

Location

Ospedale Dell Angelo

Mestre, Italy

Location

Azienda Ospedaliera San Gerardo

Monza, Italy

Location

Ospedale di Rivoli

Rivoli, Italy

Location

Ospedale San Bortolo di Vicenza Azienda ULSS 8 Berica

Vicenza, Italy

Location

King Fahd Armed Forces Hospital

Jeddah, Saudi Arabia

Location

Hospital De La Santa Creu I Sant Pau

Barcelona, Spain

Location

University Hospital Virgen Arrixaca

El Palmar, Spain

Location

Hospital de Navarra

Pamplona, Spain

Location

Hospital Universitario Nuestra Senora de Candelaria

Santa Cruz de Tenerife, Spain

Location

GHP Arytmi Center Stockholm

Stockholm, Sweden

Location

Royal Bournemouth Hospital

Bournemouth, United Kingdom

Location

Papworth Hospital

Cambridge, United Kingdom

Location

Glenfield Hospital

Leicester, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, United Kingdom

Location

Southampton University Hospital

Southampton, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 24, 2024
• Study Start: May 6, 2025
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): February 15, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

ES (4); GB (5); IT (5); GR (2); SE (1); SA (1); BE (3); AU (1); FR (3); DE (3)