Real world Data collection in subjects treated with the FARAPULSE* Pulsed Field Ablation system
- Conditions
- Atrial fibrillationirregular heartbeat10007521
- Registration Number
- NL-OMON53941
- Lead Sponsor
- Boston Scientific
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
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 (e.g., 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 non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method