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

Atrial Fibrillation Clinical Trial

— FARADISE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05501873
• Other study ID #: PF114
• Status: Active, not recruiting
• Start date: March 24, 2023
• Est. completion date: August 15, 2027

Study information

• Verified date: May 2024
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1172
• Est. completion date: August 15, 2027
• Est. primary completion date: August 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• FARAPULSE Pulsed Field Ablation system
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.

Locations

Country	Name	City	State
Australia	Prince Charles Hospital	Brisbane
Australia	Fiona Stanley Hospital	Murdoch
Australia	John Hunter Hospital	Newcastle
Austria	Allgemeines Krankenhaus AKH	Vienna
Belgium	AZ Sint Jan Hospital	Brugge
Belgium	Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse	Hasselt
Belgium	CHR de la Citadelle	Liège
Czechia	Neuron Medical in Brno	Brno
Czechia	Nemocnice Ceske Budejovice a.s.	Ceské Budejovice
Finland	Tays Heart Hospital	Tampere
France	CHU Grenoble	Grenoble
France	Hopital Saint Philibert-Hospital	Lomme
France	Hopital Prive du Confluent SAS	Nantes
France	Clinique Ambroise Pare-Hospital	Neuilly
France	Centre Cardiologique du Nord	Saint-Denis
France	Clinique Pasteur Toulouse	Toulouse
Germany	Universitaetsklinikum Aachen (UKA)	Aachen
Germany	Facharztzentrum Dresden-Neustadt Betriebsgesellschaft mbH	Dresden
Germany	Georg-August-Universitaet Goettingen	Göttingen
Germany	St Georg Asklepios	Hamburg
Germany	Universitaetsklinikum Heidelberg	Heidelberg
Germany	Staedisches Klinikum Karlsruhe	Karlsruhe
Germany	University Hospital of Muenster	Münster
Greece	Henry Dunant hospital	Athens
Greece	Onassis Cardiac Surgery Center	Athens
Hong Kong	Prince of Wales Hospital	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong
Hungary	Semmelweis University	Budapest
Ireland	Mater Private Hospital	Dublin
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	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
Malaysia	Institut Jantung Negara	Kuala Lumpur
Monaco	Princesse Grace	Monaco
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Poland	Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw
Portugal	Hospital de Santa Cruz	Carnaxide
Saudi Arabia	King Fahd Armed Forces Hospital	Jeddah
Spain	Centro Especial Ramon y Cajal	Madrid
Spain	Clinica Universidad de Navarra	Pamplona
Spain	Hospital Universitario La Fe	Valencia
Spain	Hospital Clinico Universitario Lozano Blesa	Zaragosa
United Kingdom	Royal Papworth Hospital	Cambridge
United Kingdom	Liverpool Heart & Chest Hospital	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Czechia,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Ireland,  Israel,  Italy,  Malaysia,  Monaco,  Netherlands,  Poland,  Portugal,  Saudi Arabia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Effectiveness Endpoint	Failure-free rate at 12 months post index procedure	12 monhts
Secondary	Safety endpoint	Composite of device- or procedure-related serious adverse events at early onset or chronic onset	12 months