Aortic Diseases, Aortic Stenosis Treated With TAVI
Conditions
Keywords
Embolic Protection, Transcatheter Aortic Valve Replacement, TAVR, Aortic Valve Stenosis, Aortic Valve Diseases
Brief summary
The objective of this study is to compare the safety and effectiveness of the F2 Cerebral Protection System (CPS) to a standard of care control group in patients undergoing Transcatheter Aortic Valve Replacement (TF TAVR)
Detailed description
The study is designed to demonstrate that the F2 Cerebral Protection System (CPS) performs in a consistent manner as the control group in terms of safety, and the F2 Cerebral Protection System (CPS) will be superior in performance when compared to the control group in terms of effectiveness in patients undergoing Transcatheter Aortic Valve Replacement (TF TAVR).
Interventions
Use of the F2 Filter and Delivery System in conjunction with a Transcatheter Aortic Valve Replacement (TAVR) procedure
PROCEDURETranscatheter Aortic Valve Replacement (TAVR)
Transcatheter Aortic Valve Replacement (TAVR) with commercially available Transcatheter Aortic Valve Replacement (TAVR) device
Sponsors
Avania
Insight Medical Consulting
EnCompass Technologies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Participants will be randomized in 1:1 ratio to: * Transcatheter Aortic Valve Replacement (TF TAVR) with the F2 Cerebral Protection System (CPS) (treatment group) or * Transcatheter Aortic Valve Replacement (TF TAVR) with Standard of Care treatment (no embolic protection or use of the commercially available protection device, Sentinel System; control group)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Age ≥ 50 years. * Patient meets the established criteria and indications for commercially available TAVR via transfemoral access and is scheduled to undergo TAVR per their treating physician. * Patient is willing and able to comply with protocol-specified follow-up evaluations. * Patient is able and willing to provide written informed consent. * Patient meets all criteria for use of control device (Sentinel device, per IFU). Key
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac and Cerebrovascular Events (MACCE) | 30 days post procedure | MACCE includes the composite of death, all stroke, acute kidney injury (AKI) stage 3 or 4 within 7 days post-index procedure Valve Academic Research Consortium 3 (VARC-3) and any major vascular complication (VARC-3) |
| Total New Lesion Volume | 8-72 hours post procedure | Total new lesion volume (TNLV) in the brain assessed by diffusion weighted magnetic resonance images (DW-MRI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke | 30 days post procedure | Incidence of all stroke events |
Other
| Measure | Time frame | Description |
|---|---|---|
| Average Lesion Size | 8-72 hours post procedure | Measure average lesion size in the brain, assessed by diffusion weighted magnetic resonance images (DW-MRI) |
| Neurological Outcomes-National Institute of Health Stroke Scale (NIHSS) | 30 days post procedure | Use National Institute of Health Stroke Scale (NIHSS) to measure stroke severity on a scale of 0-41 (low score is better outcome). |
| Neurological Outcomes-Montreal Cognitive Assessment (MoCA) | 30 days post procedure | Use Montreal Cognitive Assessment (MoCA) to measure cognitive impairment on a scale of 0-30 (high score is better outcome). |
| Neurological Outcomes-Modified Rankin Scale (MRS) | 30 days post procedure | Use Modified Rankin Scale (MRS) to measure neurological disability on scale of 0-6 (Low score is better outcome) |
| Major Vascular Complication & Bleeding | During procedure | Measure major vascular complications (as defined by VARC-3) & major bleeding (Type 3, Type 4 as defined by VARC- 3) |
| Performance | During procedure | Technical success (% of patients with successful device deployment, position and retrieval) and procedure success (% of patients with technical device success and no device-related safety events) |
| Index Hospital Length of Stay (LOS) | Through 30 days | Measure Index hospitalization LOS |
| Index Hospitalization ICU Length of Stay (LOS) | Through 30 days | Measure Index hospitalization ICU length of stay |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | 30 days post procedure | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a self-reported questionnaire that measures physical function, symptoms, social function, and quality of life, on a scale from 0 to 100 (higher score is better outcome). |
| Short Form (SF-12) Questionnaire | 30 days post procedure | The Short Form (SF-12) Questionnaire is a self-reported questionnaire that assess the impact of health on an individual's everyday life, on a scale from 0 to 100 (higher score is better health). |
| Hospital Readmissions | 30 days post procedure | Measure number of hospital readmissions at 30 days and number of ICU readmissions during hospital stay and 30 days |
| Mortality & Stroke Rates | 30 days post procedure | Incidences of all-cause mortality, major stroke, minor stroke events |
| Freedom from Lesions | 8-72 hours post procedure | Measure presence or absence of new lesions in the brain, assessed by diffusion weighted magnetic resonance images (DW-MRI) |
Countries
Australia, United States
Contacts
Primary ContactKathleen S Calderon
Outcome results
None listed