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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05501873




Registration number
NCT05501873
Ethics application status
Date submitted
12/08/2022
Date registered
16/08/2022
Date last updated
25/06/2024

Titles & IDs
Public title
Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System
Scientific title
Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System
Secondary ID [1] 0 0
PF114
Universal Trial Number (UTN)
Trial acronym
FARADISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - FARAPULSE Pulsed Field Ablation system

Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Effectiveness Endpoint
Timepoint [1] 0 0
12 monhts
Secondary outcome [1] 0 0
Safety endpoint
Timepoint [1] 0 0
12 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/08/2027
Actual
Sample size
Target
Accrual to date
Final
1172
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Prince Charles Hospital - Brisbane
Recruitment hospital [2] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [3] 0 0
John Hunter Hospital - Newcastle
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Murdoch
Recruitment postcode(s) [3] 0 0
- Newcastle
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Belgium
State/province [2] 0 0
Brugge
Country [3] 0 0
Belgium
State/province [3] 0 0
Hasselt
Country [4] 0 0
Belgium
State/province [4] 0 0
Liège
Country [5] 0 0
Czechia
State/province [5] 0 0
Brno
Country [6] 0 0
Czechia
State/province [6] 0 0
Ceské Budejovice
Country [7] 0 0
Finland
State/province [7] 0 0
Tampere
Country [8] 0 0
France
State/province [8] 0 0
Grenoble
Country [9] 0 0
France
State/province [9] 0 0
Lomme
Country [10] 0 0
France
State/province [10] 0 0
Nantes
Country [11] 0 0
France
State/province [11] 0 0
Neuilly
Country [12] 0 0
France
State/province [12] 0 0
Saint-Denis
Country [13] 0 0
France
State/province [13] 0 0
Toulouse
Country [14] 0 0
Germany
State/province [14] 0 0
Aachen
Country [15] 0 0
Germany
State/province [15] 0 0
Dresden
Country [16] 0 0
Germany
State/province [16] 0 0
Göttingen
Country [17] 0 0
Germany
State/province [17] 0 0
Hamburg
Country [18] 0 0
Germany
State/province [18] 0 0
Heidelberg
Country [19] 0 0
Germany
State/province [19] 0 0
Karlsruhe
Country [20] 0 0
Germany
State/province [20] 0 0
Münster
Country [21] 0 0
Greece
State/province [21] 0 0
Athens
Country [22] 0 0
Hong Kong
State/province [22] 0 0
Hong Kong
Country [23] 0 0
Hungary
State/province [23] 0 0
Budapest
Country [24] 0 0
Ireland
State/province [24] 0 0
Dublin
Country [25] 0 0
Israel
State/province [25] 0 0
Tel Aviv
Country [26] 0 0
Italy
State/province [26] 0 0
Ancona
Country [27] 0 0
Italy
State/province [27] 0 0
Mercogliano
Country [28] 0 0
Italy
State/province [28] 0 0
Rivoli
Country [29] 0 0
Italy
State/province [29] 0 0
Roma
Country [30] 0 0
Italy
State/province [30] 0 0
Vicenza
Country [31] 0 0
Malaysia
State/province [31] 0 0
Kuala Lumpur
Country [32] 0 0
Monaco
State/province [32] 0 0
Monaco
Country [33] 0 0
Netherlands
State/province [33] 0 0
Eindhoven
Country [34] 0 0
Netherlands
State/province [34] 0 0
Nieuwegein
Country [35] 0 0
Poland
State/province [35] 0 0
Warsaw
Country [36] 0 0
Portugal
State/province [36] 0 0
Carnaxide
Country [37] 0 0
Saudi Arabia
State/province [37] 0 0
Jeddah
Country [38] 0 0
Spain
State/province [38] 0 0
Madrid
Country [39] 0 0
Spain
State/province [39] 0 0
Pamplona
Country [40] 0 0
Spain
State/province [40] 0 0
Valencia
Country [41] 0 0
Spain
State/province [41] 0 0
Zaragosa
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Cambridge
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Liverpool

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05501873
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries