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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
CLAAS® System
DeviceThe CLAAS® System delivers a plug to the ostia of the Left Atrial Appendage (LAA) and is designed to occlude the appendage to eliminate blood flow. It is designed to conform to the geometry of the LAA. The implant is designed to permanently seal off the LAA from the LA with an endothelial layer that forms across the LA face of the implant. The implant is available in two different sizes; Regular (27mm) and Large (35mm) to accommodate patient anatomy. Angiography and/or echocardiography may be used to determine the LAA ostium diameter to properly select the Implant size. The implant has an inner, cylindrical, Nitinol endoskeleton that provides the mechanical base structure. The Nitinol endoskeleton contains 10 face struts and 20 anchors (Regular) and 12 struts and 24 anchors (Large) facing proximally to engage the tissue to resist movement. The endoskeleton also provides the conformable structure to enable the foam cylinder to compress against the LAA tissue to facilitate sealing.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: CLAASExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Efficacy: Evaluating the Performance of CLAAS, as defined below:
1. Successful implantation of the LAAO Device in the LAA with acceptable position (e.g. as measured at LAA orifice) through 45 days post-procedure 2. Complete closure or peri-device residual leak ≤5 mm in width on TEE, as evaluated by independent core lab at 45 days post-procedure 3. Without in-hospital major procedure-related complications during hospitalization or at 7 days, whichever is first
Time frame
7 days through 45 days post-procedure2
Primary Safety: A Composite of Major Procedure-Related Complications Assessed through 45-Days
A composite of Major Procedure-related complications assessed through 45 days (listed below) as adjudicated by an independent Clinical Events Committee as related to either the study device or procedure. Major Procedure-Related Complications includes any of the following specific events with the specific definitions outlined for each component: * cardiac perforation, * pericardial effusion requiring drainage, * ischemic stroke, * device embolization, * major vascular complications
Time frame
45 days post procedureLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: