The CLAAS® device will be evaluated for safety and performance in the reduction of stroke in subjects with non-valvular atrial fibrillation under intracardiac echocardiography (ICE) imaging for left atrial appendage closure.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or non-pregnant female aged ≥18 years.
✓. Documented non-valvular AF (paroxysmal, persistent, or permanent).
✓. High risk of stroke or systemic embolism, defined as CHADS2 score of ≥2 or CHA2DS2-VASc score of ≥3.
✓. Has an appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation including contraindications to long term oral anti-coagulation inclusive of history of intracranial bleed, subdural hematoma, gastrointestinal bleeding, hematuria, epistaxis, falls, and other less common conditions. Also included is the inability to reliably take medications and reluctance to take a blood thinner.
✓. Deemed by investigator to be suitable for short term oral anticoagulation therapy but deemed less favorable for long-term oral anticoagulation therapy.
✓. Deemed appropriate for LAA closure by the site investigator and a clinician not a part of the procedural team using a shared decision-making process in accordance with standard of care.
✓. Able to comply with the protocol-specified medication regimen and follow-up evaluations.
✓. The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate institutional review board (IRB)/Regional Ethics Board (REB)/Ethics Committee (EC).
Exclusion criteria
✕. Pregnant or nursing patients and those who plan pregnancy in the period up to one year following the index procedure. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure.
What they're measuring
1
Successful LAA closure (Evaluated at 45 Days Post-procedure)
Timeframe: 45 Days
2
Successful LAA closure without procedural complication within 7 days post-procedure
✕. Anatomic conditions that would prevent performance of an LAA occlusion procedure (e.g., prior atrial septal defect \[ASD\] or patent foramen ovale \[PFO\], surgical repair or implanted closure device, or obliterated or ligated left atrial appendage).
✕. Atrial fibrillation that is defined by a single occurrence or that is transient or reversible (e.g., secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures).
✕. A medical condition (other than atrial fibrillation) that mandates long-term oral anticoagulation (e.g., history of unprovoked deep vein thrombosis or pulmonary embolism, or mechanical heart valve).
✕. History of bleeding diathesis or coagulopathy, or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated.
✕. Documented active systemic infection.
✕. Symptomatic carotid artery disease (defined as \>50% stenosis with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is \<50% stenosis noted at the site of prior treatment.
✕. Recent (within 30 days of index procedure) or planned (within 60 days post-procedure) cardiac or non-cardiac interventional or surgical procedure.