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

Active, not recruiting

• Conditions: Atrial Fibrillation

• Registration Number: NCT05501873
• Lead Sponsor: Boston Scientific Corporation

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.

Detailed Description

This Registry is intended to obtain purely observational and prospective real world data about the cardiac ablation procedure in subjects treated with the FARAPULSE™ Pulsed Field Ablation system, to provide continued evidence on the safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation (PFA) System when used per hospitals' standard of care, and to learn the effect of the Pulsed Field Ablation treatment on Quality Of Life in a real-world setting. The study will enroll approximately 1000 to 1500 subjects, in up to 100 sites in Europe (with the potential for expansion of the study to Middle East, Africa and/or Asia Pacific).

Study Timeline

• Study First Submitted: 2022-08-12
• Study First Submitted QC: 2022-08-12
• Study First Posted: 2022-08-16
• Study Start: 2023-03-24
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-07
• Primary Completion: 2027-08-15
• Study Completion: 2027-08-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1173

Inclusion Criteria

1. 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
2. Subjects who are willing and capable of providing informed consent
3. Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center
4. 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

1. Subjects with a current interatrial baffle or patch
2. Subjects with a known or suspected atrial myxoma
3. Subjects with a myocardial infarction within 14 days prior to enrollment
4. Subjects with a recent (within 30 days prior to enrollment) Cerebral Vascular Accident (CVA)
5. Subjects who do not tolerate anticoagulation therapy
6. Subjects with an active systemic infection *
7. Subjects with a presence of atrial known thrombus *
8. Subjects with a known inability to obtain vascular access
9. Subjects who are pregnant or planning to be pregnant
10. Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
11. Subjects with any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty
12. 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)
13. Subjects with a life expectancy of ≤ 1 year per investigator's opinion
14. 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness Endpoint	12 monhts	Failure-free rate at 12 months post index procedure

Secondary Outcome Measures

Name	Time	Method
Safety endpoint	12 months	Composite of device- or procedure-related serious adverse events at early onset or chronic onset

Trial Locations

Locations (48)

CHU Grenoble; 🇫🇷 Grenoble, France

Prince Charles Hospital; 🇦🇺 Brisbane, Australia

John Hunter Hospital; 🇦🇺 Newcastle, Australia

Fiona Stanley Hospital; 🇦🇺 Murdoch, Australia

Allgemeines Krankenhaus AKH; 🇦🇹 Vienna, Austria

Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse; 🇧🇪 Hasselt, Belgium

CHR de la Citadelle; 🇧🇪 Liège, Belgium

Nemocnice Ceske Budejovice a.s.; 🇨🇿 České Budějovice, Czechia

Neuron Medical in Brno; 🇨🇿 Brno, Czechia

Tays Heart Hospital; 🇫🇮 Tampere, Finland

Hopital Saint Philibert-Hospital; 🇫🇷 Lomme, France

Hopital Prive du Confluent SAS; 🇫🇷 Nantes, France

Clinique Ambroise Pare-Hospital; 🇫🇷 Neuilly, France

Clinique Pasteur Toulouse; 🇫🇷 Toulouse, France

Universitaetsklinikum Aachen (UKA); 🇩🇪 Aachen, Germany

Facharztzentrum Dresden-Neustadt Betriebsgesellschaft mbH; 🇩🇪 Dresden, Germany

Georg-August-Universitaet Goettingen; 🇩🇪 Göttingen, Germany

University Hospital of Muenster; 🇩🇪 Münster, Germany

St Georg Asklepios; 🇩🇪 Hamburg, Germany

Universitaetsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Staedisches Klinikum Karlsruhe; 🇩🇪 Karlsruhe, Germany

Onassis Cardiac Surgery Center; 🇬🇷 Athens, Greece

Mater Private Hospital; 🇮🇪 Dublin, Ireland

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

Az. Osp. Lancisi-Hospital; 🇮🇹 Ancona, Italy

Casa Di Cura 'Montevergine' S.P.A.; 🇮🇹 Mercogliano, Italy

Ospedale Rivoli; 🇮🇹 Rivoli, Italy

Ospedale Isola Tiberina Gemelli Isola; 🇮🇹 Roma, Italy

Ospedale San Bortolo de Vicenza; 🇮🇹 Vicenza, Italy

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands

Centro Especial Ramon y Cajal; 🇪🇸 Madrid, Spain

Clinica Universidad de Navarra; 🇪🇸 Pamplona, Spain

Hospital Clinico Universitario Lozano Blesa; 🇪🇸 Zaragosa, Spain

Hospital Universitario La Fe; 🇪🇸 Valencia, Spain

Liverpool Heart & Chest Hospital; 🇬🇧 Liverpool, United Kingdom

Royal Papworth Hospital; 🇬🇧 Cambridge, United Kingdom

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego; 🇵🇱 Warsaw, Poland

King Fahd Armed Forces Hospital; 🇸🇦 Jeddah, Saudi Arabia

Semmelweis University; 🇭🇺 Budapest, Hungary

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong

Princesse Grace; 🇲🇨 Monaco, Monaco

Henry Dunant hospital; 🇬🇷 Athens, Greece

Institut Jantung Negara; 🇲🇾 Kuala Lumpur, Malaysia

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Hospital de Santa Cruz; 🇵🇹 Carnaxide, Portugal

AZ Sint Jan Hospital; 🇧🇪 Brugge, Belgium

Centre Cardiologique du Nord; 🇫🇷 Saint-Denis, France