Phase
Condition
Dysrhythmia
Arrhythmia
Chest Pain
Treatment
FARAPULSE™ Pulsed Field Ablation system
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects intended to be treated with the FARAPULSE™ Pulsed Field Ablation system forcardiac tissue ablation, per physician's medical judgement, and as per hospitals'standard of care
Subjects who are willing and capable of providing informed consent
Subjects who are willing and capable of participating in all testing associated withthis clinical study at an approved clinical investigational center
Subjects whose age is 18 years or above.
Exclusion
Exclusion Criteria:
Subjects with a current interatrial baffle or patch
Subjects with a known or suspected atrial myxoma
Subjects with a myocardial infarction within 14 days prior to enrollment
Subjects with a recent (within 30 days prior to enrollment) Cerebral VascularAccident (CVA)
Subjects who do not tolerate anticoagulation therapy
Subjects with an active systemic infection *
Subjects with a presence of atrial known thrombus *
Subjects with a known inability to obtain vascular access
Subjects who are pregnant or planning to be pregnant
Subjects with atrial fibrillation that is secondary to electrolyte imbalance,thyroid disease, alcohol, or other reversible / non-cardiac causes
Subjects with any prosthetic heart valve, ring or repair including balloon aorticvalvuloplasty
Subjects with a contraindication to an invasive electrophysiology procedure whereinsertion or manipulation of a catheter in the cardiac chambers is deemed unsafe perphysician's medical judgement, such as, but not limited to, a recent previouscardiac surgery (e.g., ventriculotomy or atriotomy, CABG, PTCA/PCI/coronary stentprocedure), recent previous unstable angina and/or in patients with congenital heartdisease where the underlying abnormality increases the risk of the ablation (e.g.,severe rotational anomalies of the heart or great vessels)
Subjects with a life expectancy of ≤ 1 year per investigator's opinion
Subjects who are currently enrolled in another investigational study or registrythat would directly interfere with the current study, except when the subject isparticipating in a mandatory governmental registry, or a purely observationalregistry with no associated treatments. Each instance must be brought to theattention of the sponsor to determine eligibility.
Study Design
Study Description
Connect with a study center
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China/Beijing 100037
ChinaActive - Recruiting

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