Conscious Sedation Study
ConditionAtrial Fibrillation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorConformal Medical, Inc
About this trial
The Conscious Sedation Single Arm Sub-Study is designed to evaluate the safety and performance of the CLAAS device implantation procedure using conscious sedation.
Eligibility criteria
Qualifiers
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.
Deemed by the site investigator to be suitable for short term oral anticoagulation therapy but deemed less favorable for long-term oral anticoagulation therapy .
Disqualifiers
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.
Anatomic conditions that would prevent performance of an LAA occlusion procedure (e.g., prior atrial septal defect [ASD] or high-risk 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).
Trial design
Treatments tested in this trial
- CLAAS® System
Treatment groups
300 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov