Clinical trial NCT05501873: Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System
Official title: Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2022-08-16
Enrollment: 1173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).

Eligibility criteria: 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

Primary outcomes:
measure: Primary Effectiveness Endpoint
timeFrame: 12 monhts
Secondary outcomes:
measure: Safety endpoint
timeFrame: 12 months
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Prince Charles Hospital
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
city: Newcastle
country: Australia
facility: John Hunter Hospital
city: Vienna
country: Austria
facility: Allgemeines Krankenhaus AKH
city: Brugge
country: Belgium
facility: AZ Sint Jan Hospital
city: Hasselt
country: Belgium
facility: Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse
city: Liège
country: Belgium
facility: CHR de la Citadelle
city: Brno
country: Czechia
facility: Neuron Medical in Brno
city: České Budějovice
country: Czechia
facility: Nemocnice Ceske Budejovice a.s.
city: Tampere
country: Finland
facility: Tays Heart Hospital
city: Grenoble
country: France
facility: CHU Grenoble
city: Lomme
country: France
facility: Hopital Saint Philibert-Hospital
city: Nantes
country: France
facility: Hopital Prive du Confluent SAS
city: Neuilly
country: France
facility: Clinique Ambroise Pare-Hospital
city: Saint-Denis
country: France
facility: Centre Cardiologique du Nord
city: Toulouse
country: France
facility: Clinique Pasteur Toulouse
city: Aachen
country: Germany
facility: Universitaetsklinikum Aachen (UKA)
city: Dresden
country: Germany
facility: Facharztzentrum Dresden-Neustadt Betriebsgesellschaft mbH
city: Göttingen
country: Germany
facility: Georg-August-Universitaet Goettingen
city: Hamburg
country: Germany
facility: St Georg Asklepios
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Karlsruhe
country: Germany
facility: Staedisches Klinikum Karlsruhe
city: Münster
country: Germany
facility: University Hospital of Muenster
city: Athens
country: Greece
facility: Henry Dunant hospital
city: Athens
country: Greece
facility: Onassis Cardiac Surgery Center
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Budapest
country: Hungary
facility: Semmelweis University
city: Dublin
country: Ireland
facility: Mater Private Hospital
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Ancona
country: Italy
facility: Az. Osp. Lancisi-Hospital
city: Mercogliano
country: Italy
facility: Casa Di Cura 'Montevergine' S.P.A.
city: Rivoli
country: Italy
facility: Ospedale Rivoli
city: Roma
country: Italy
facility: Ospedale Isola Tiberina Gemelli Isola
city: Vicenza
country: Italy
facility: Ospedale San Bortolo de Vicenza
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara
city: Monaco
country: Monaco
facility: Princesse Grace
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Warsaw
country: Poland
facility: Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
city: Carnaxide
country: Portugal
facility: Hospital de Santa Cruz
city: Jeddah
country: Saudi Arabia
facility: King Fahd Armed Forces Hospital
city: Madrid
country: Spain
facility: Centro Especial Ramon y Cajal
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Zaragosa
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital
city: Liverpool
country: United Kingdom
facility: Liverpool Heart & Chest Hospital
Study officials:
References: