Informations générales (source: ClinicalTrials.gov)
Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System (FARADISE)
Observational [Patient Registry]
Boston Scientific Corporation (Voir sur ClinicalTrials)
mars 2023
août 2027
26 juillet 2025
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.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre Cardiologique du Nord - Saint-Denis - France | Contact (sur clinicalTrials) | ||||
| CHU Grenoble - Grenoble - France | Contact (sur clinicalTrials) | ||||
| Clinique Ambroise Pare-Hospital - Neuilly - France | Contact (sur clinicalTrials) | ||||
| Clinique Pasteur Toulouse - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Hopital Prive du Confluent SAS - Nantes - France | Contact (sur clinicalTrials) | ||||
| Hopital Saint Philibert-Hospital - Lomme - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
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
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