Non-valvular Atrial Fibrillation
Conditions
Brief summary
A prospective, single center, open-label, single arm, study to evaluate the safety and technical performance of the CLAAS system for closure of the left atrial appendage.
Detailed description
The primary objective of the study is to evaluate feasibility of ICE as primary imaging modality for device success in patients with non-valvular atrial fibrillation at increased risk for stroke and systemic embolism who are recommended for oral anticoagulation (OAC) therapy but have an appropriate rationale to seek a non-pharmacological alternative to OAC. TEE will be used to confirm the ICE evaluation.
Interventions
DEVICELeft Atrial Appendage Closure
Closure of the left atrial appendage (LAAC) is performed percutaneously. Implantation of the LAAC device will be performed according to device specific instructions for use based on both TEE guidance, ICE and angiography, femoral access and inter-atrial septum crossing
Sponsors
Conformal Medical, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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 a CHA2DS2-VASc score of ≥ 2 4. The patient is recommended for oral anticoagulation therapy (OAC), but has an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulation 5. The patient is willing and able to comply with the protocol-specified medication regimen and follow-up evaluations 6. The patient (or legally authorized representative) has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate Ethics Committee (EC)
Exclusion criteria
1. Pregnant or nursing patients and those who plan pregnancy in the period up to 1 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. Patients with a medical condition (other than atrial fibrillation) that mandates chronic 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. Active infection with bacteremia 7. Documented symptomatic carotid artery disease (\>50% diameter stenosis with prior ipsilateral stroke or TIA) or known asymptomatic carotid artery disease (diameter stenosis of \>70%) 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 90 days of index procedure) stroke, transient ischemic attack 10. Recent myocardial infarction within 60 days of index procedure 11. Vascular access precluding delivery of implant with catheter-based system 12. Severe heart failure (New York Heart Association Class III or 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) \<30 mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation), or dialysis at the time of screening 15. Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3, or white blood cell count \<3,000 cells/mm3 16. Patient has a known allergy, hypersensitivity or contraindication to aspirin, heparin, clopidogrel, prasugrel, ticagrelor, or device materials (e.g., nickel, titanium, gold), or the patient has contrast sensitivity that cannot be adequately pre-medicated 17. Current participation in another investigational drug or device study that interferes with this study 18. Patient is a prisoner 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 1 year 20. Patient has a condition which precludes adequate transesophageal echocardiographic (TEE) assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Major Adverse Events | 7 days post-procedure | Major adverse events defined as: All cause mortality, ischemic stroke, systemic thromboembolism, device or procedure-related adverse events requiring open cardiac surgery or major endovascular intervention. |
| Closure Success | 45-days post-procedure | Closure success, defined as device success followed by complete closure or peri-device residual leak ≤5 mm in width |
Countries
Czechia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non-valvular AF Adults Left atrial appendage closure (LAAC) with the Conformal LAAC device will be performed according to the device Instructions for Use, based on ICE and angiographic guidance, femoral venous access and inter-atrial septum crossing.
Left Atrial Appendage Closure: Closure of the left atrial appendage (LAAC) is performed percutaneously. Implantation of the LAAC device will be performed according to device specific instructions for use based on both TEE guidance, ICE and angiography, femoral access and inter-atrial septum crossing | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Non-valvular AF Adults | — |
|---|---|---|
| Age, Customized Age | 72.3 years STANDARD_DEVIATION 9.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Czechia | 19 participants | — |
| Sex: Female, Male Female | 11 Participants | — |
| Sex: Female, Male Male | 8 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 19 |
| other Total, other adverse events | 7 / 19 |
| serious Total, serious adverse events | 6 / 19 |
Outcome results
Primary
Closure Success
Closure success, defined as device success followed by complete closure or peri-device residual leak ≤5 mm in width
Time frame: 45-days post-procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 7 Day Success | Closure Success | No residual flow | 12 Participants |
| 7 Day Success | Closure Success | 1 - 2 mm | 3 Participants |
| 7 Day Success | Closure Success | >2mm | 0 Participants |
Primary
Freedom From Major Adverse Events
Major adverse events defined as: All cause mortality, ischemic stroke, systemic thromboembolism, device or procedure-related adverse events requiring open cardiac surgery or major endovascular intervention.
Time frame: 7 days post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 7 Day Success | Freedom From Major Adverse Events | 19 Participants |