Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System

NCT05501873 | Active Not Recruiting

• 1 other identifier: PF114
• Study Type: observational
• Target: 1,173
• Locations: 20 countries
• Sites: 45

Brief Summary

The goal of any novel design or therapeutic strategy to treat atrial fibrillation is to restore normal sinus rhythm and to reduce or eliminate the symptoms due to rapid atrial response. Boston Scientific has developed the FARAPULSE™ Pulsed Field Ablation therapy that uses irreversible electroporation to induce cell death. This Registry is intended to obtain purely observational and prospective real world data and to provide continued evidence on the safety and effectiveness when the FARAPULSE™ pulsed field ablation System is used per hospitals' standard of care.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Primary Effectiveness Endpoint

  Failure-free rate at 12 months post index procedure

  12 monhts

Secondary Outcomes (1)

• Safety endpoint

  12 months

Interventions

FARAPULSE Pulsed Field Ablation system DEVICE

Any subject who has signed the informed consent and for whom the FARAPULSE Pulsed Field Ablation system has been inserted into the body, and pulsed field ablation treatment has been received, are assigned to the treatment group.

Eligibility Criteria

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

Study Population

Subjects enrolled in the FARADISE study will be clinically indicated for an ablation procedure with the FARAPULSE™ Pulsed Field Ablation system, per physician's medical judgement, and according to the hospitals' standard of care

You may qualify if:

• Subjects 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 in all testing associated with this clinical study 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 with a current interatrial baffle or patch
• Subjects with a known or suspected atrial myxoma
• Subjects with a myocardial infarction within 14 days prior to enrollment
• Subjects with a recent (within 30 days prior to enrollment) Cerebral Vascular Accident (CVA)
• Subjects who do not tolerate anticoagulation therapy
• Subjects with an active systemic infection \*
• Subjects with a presence of atrial known thrombus \*
• Subjects with a known inability to obtain vascular access
• Subjects who are pregnant or planning to be pregnant
• Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
• Subjects with any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty
• Subjects with a contraindication to an invasive electrophysiology procedure where insertion or manipulation of a catheter in the cardiac chambers is deemed unsafe per physician's medical judgement, such as, but not limited to, a recent previous cardiac surgery (eg. ventriculotomy or atriotomy, CABG, PTCA/PCI/coronary stent procedure/unstable angina) and/or in patients with congenital heart disease where the underlying abnormality increases the risk of the ablation (e.g., severe rotational anomalies of the heart or great vessels)
• Subjects with a life expectancy of ≤ 1 year per investigator's opinion
• Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (48)

Prince Charles Hospital

Brisbane, Australia

Location

Fiona Stanley Hospital

Murdoch, Australia

Location

John Hunter Hospital

Newcastle, Australia

Location

Allgemeines Krankenhaus AKH

Vienna, Austria

Location

AZ Sint Jan Hospital

Bruges, Belgium

Location

Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse

Hasselt, Belgium

Location

CHR de la Citadelle

Liège, Belgium

Location

Neuron Medical in Brno

Brno, Czechia

Location

Nemocnice Ceske Budejovice a.s.

České Budějovice, Czechia

Location

Tays Heart Hospital

Tampere, Finland

Location

CHU Grenoble

Grenoble, France

Location

Hopital Saint Philibert-Hospital

Lomme, France

Location

Hopital Prive du Confluent SAS

Nantes, France

Location

Clinique Ambroise Pare-Hospital

Neuilly, France

Location

Centre Cardiologique du Nord

Saint-Denis, France

Location

Clinique Pasteur Toulouse

Toulouse, France

Location

Universitaetsklinikum Aachen (UKA)

Aachen, Germany

Location

Facharztzentrum Dresden-Neustadt Betriebsgesellschaft mbH

Dresden, Germany

Location

Georg-August-Universitaet Goettingen

Göttingen, Germany

Location

St Georg Asklepios

Hamburg, Germany

Location

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Location

Staedisches Klinikum Karlsruhe

Karlsruhe, Germany

Location

University Hospital of Muenster

Münster, Germany

Location

Henry Dunant hospital

Athens, Greece

Location

Onassis Cardiac Surgery Center

Athens, Greece

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Semmelweis University

Budapest, Hungary

Location

Mater Private Hospital

Dublin, Ireland

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Az. Osp. Lancisi-Hospital

Ancona, Italy

Location

Casa Di Cura 'Montevergine' S.P.A.

Mercogliano, Italy

Location

Ospedale Rivoli

Rivoli, Italy

Location

Ospedale Isola Tiberina Gemelli Isola

Roma, Italy

Location

Ospedale San Bortolo de Vicenza

Vicenza, Italy

Location

Institut Jantung Negara

Kuala Lumpur, Malaysia

Location

Princesse Grace

Monaco, Monaco

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

Warsaw, Poland

Location

Hospital de Santa Cruz

Carnaxide, Portugal

Location

King Fahd Armed Forces Hospital

Jeddah, Saudi Arabia

Location

Centro Especial Ramon y Cajal

Madrid, Spain

Location

Clinica Universidad de Navarra

Pamplona, Spain

Location

Hospital Universitario La Fe

Valencia, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, Spain

Location

Royal Papworth Hospital

Cambridge, United Kingdom

Location

Liverpool Heart & Chest Hospital

Liverpool, 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
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 16, 2022
• Study Start: March 24, 2023
• Primary Completion: October 21, 2025
• Study Completion (Estimated): August 15, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2); HK (2); IL (1); GR (2); MY (1); FI (1); IE (1); FR (6); HU (1); AU (1); IT (5); CZ (2); BE (3); MO (1); NL (2); PL (1); ES (4); SA (1); DE (7); PT (1)