Atrial Fibrillation, Stroke Prevention
Conditions
Keywords
Atrial fibrillation, Stroke, ICE, Conformal, LAAO
Brief summary
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.
Interventions
DEVICECLAAS
All eligible subjects will have an LAA closure attempt using the CLAAS device guided by ICE technology.
Sponsors
Conformal Medical, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or non-pregnant female aged ≥18 years. 2. Documented non-valvular AF (paroxysmal, persistent, or permanent). 3. High risk of stroke or systemic embolism, defined as CHADS2 score of ≥2 or CHA2DS2-VASc score of ≥3. 4. 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. 5. Deemed by investigator to be suitable for short term oral anticoagulation therapy but deemed less favorable for long-term oral anticoagulation therapy. 6. 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. 7. Able to comply with the protocol-specified medication regimen and follow-up evaluations. 8. 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
1. 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. 2. 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). 3. 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). 4. 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). 5. History of bleeding diathesis or coagulopathy, or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated. 6. Documented active systemic infection. 7. 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. 8. Recent (within 30 days of index procedure) or planned (within 60 days post-procedure) cardiac or non-cardiac interventional or surgical procedure. 9. Recent (within 30 days of index procedure) stroke or transient ischemic attack. 10. Recent (within 30 days of index procedure) myocardial infarction. 11. Vascular access precluding delivery of implant with catheter-based system. 12. Severe heart failure (New York Heart Association Class IV). 13. Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any mechanical valve implant. 14. Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \<30mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation). 15. Platelet count \<75,000 cells/mm3 or \>700,000 cells/mm3, or white blood cell count \<3,000 cells/mm3. 16. Known allergy, hypersensitivity or contraindication to aspirin, heparin, or device materials (e.g., nickel, titanium) that would preclude any P2Y12 inhibitor therapy, or the patient has contrast sensitivity that cannot be adequately pre-medicated. 17. Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this study. 18. Unable to undergo general anesthesia. 19. Known other medical illness or known history of substance abuse that may cause non-compliance with the protocol or protocol-specified medication regimen, confound the data interpretation, or is associated with a life expectancy of less than 5 years. 20. A condition which precludes adequate transesophageal echocardiographic (TEE) assessment or ICE guided imaging during the procedure. Imaging
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful LAA closure (Evaluated at 45 Days Post-procedure) | 45 Days | Complete closure is defined as absence of a significant leak (\>5 mm) as assessed based upon core lab evaluation of 45 Day Imaging assessment without device or procedure related SAEs. |
| Successful LAA closure without procedural complication within 7 days post-procedure | 7 Days | The absences of any of the following complications: Cardiac perforation, pericardial effusion requiring drainage, ischemic stroke, device embolization, and major vascular complications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke: Ischemic, Hemorrhagic, Disabling, Non-Disabling | 12 Months | — |
| Bleeding (BARC 3-5) | 14 Days | Procedural and Non-Procedural |
| Device Leak | 45 Days | \>5 mm, 3-5 mm, 1-3 mm leak is based on core lab imaging assessment at 45 days |
| Pericardial Effusion requiring drainage | 12 Months | — |
| Procedural and Device related AEs and SAEs | 1 Day | — |
| Device Success | 1 Day | CLAAS implantation in correct position without complications till discharge |
| Conversion to TEE | 1 Day | — |
| Conversion to general anesthesia (GA) with endotracheal intubation | 1 Day | — |
Countries
Czechia, Denmark, Italy
Outcome results
None listed