Not Yet RecruitingNot Applicable

Conscious Sedation Study

300 participantsStarted 2027-08-01

Plain-language summary

The Conscious Sedation Single Arm Sub-Study is designed to evaluate the safety and performance of the CLAAS device implantation procedure using conscious sedation.

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.
✓. Deemed by the site 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 (or legally authorized representative, where allowed) 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).

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.
✕. 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).
✕. 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 major non-cardiac interventional or surgical procedure.

What they're measuring

Primary Efficacy: Evaluating the Performance of CLAAS, as defined below:

Timeframe: 7 days through 45 days post-procedure

Primary Safety: A Composite of Major Procedure-Related Complications Assessed through 45-Days

Timeframe: 45 days post procedure

Trial details

NCT IDNCT06049615

SponsorConformal Medical, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-05-01

View on ClinicalTrials.gov More Atrial Fibrillation trials