Phase
Condition
Arrhythmia
Cardiac Disease
Atrial Fibrillation
Treatment
FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Clinically indicated for treatment with both the FARAPULSE™ PFA system and withWATCHMAN for LAAC, per physician medical judgement and as per hospitals' standard ofcare.
Subjects who are willing and able to provide informed consent.
Subjects who are willing and able to participate in all testing associated with thisclinical study at an approved clinical investigational center.
Subjects whose age is 18 years or above, or who are of legal age to give informedconsent specific to state and national law.
Exclusion
Exclusion Criteria:
Subjects who underwent prior AF ablation procedure.
Subjects with atrial fibrillation that is secondary to electrolyte imbalance,thyroid disease, alcohol, or other reversible / non-cardiac causes.
Already surgically closed or otherwise excluded LAA.
The LAA anatomy does not accommodate a Closure Device.
Known or suspected atrial myxoma.
Presence of intracardiac thrombus.
Subjects with a current interatrial baffle or patch, history of atrial septal repairor has an ASD/PFO device.
Subjects with a presence of a mechanical valve prosthesis in any position.
Subjects with a myocardial infarction within 30 days prior to enrollment.
Subjects had a prior stroke (of any cause, whether ischemic or hemorrhagic) ortransient ischemic attack (TIA) within the 90 days prior to enrollment.
Any planned electrical cardioversion within 30 days following LAAC device implant.
Subjects with a known inability to obtain vascular access.
Subjects with any contraindication to percutaneous catheterization procedure (e.g.,patient size does not accommodate required catheters, ventriculotomy or atriotomy),active conditions (e.g. infection, bleeding disorder, unstable angina) or congenitalabnormalities (severe rotational anomalies of the heart or great vessels) arepresent*.
Subjects with any contraindications to short term use of anticoagulation therapy, oraspirin for conditions different from atrial fibrillation.
Subjects who are pregnant or planning to be pregnant.
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 reviewed by thesponsor to determine eligibility.
Study Design
Study Description
Connect with a study center
Institute Jantung Negara
Kuala Lumpur,
MalaysiaActive - Recruiting
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