Aortic Valve Stenosis
Conditions
Keywords
Transcatheter Aortic Valve Replacement, Aortic Valve Replacement
Brief summary
The objective of this study is to demonstrate device feasibility, safety and investigate performance of the EmStop Embolic Protection System when used as indicated in 15 subjects at 2 investigational sites in the U.S.
Detailed description
The investigation is a prospective, multi-center, single arm feasibility study. Subjects will undergo treatment with a currently marketed TAVR device and the EmStop Embolic Protection System and will then be followed to 30 days post-procedure. This is a treatment-only feasibility investigation intended to capture and characterize outcomes, especially safety outcomes, with the EmStop System.
Interventions
DEVICEThe EmStop Embolic Protection System (EmStop System)
The EmStop Embolic Protection System (EmStop System) is a catheter-based filter system that captures and removes debris dislodged during transcatheter aortic valve replacement (TAVR) procedures.
Sponsors
Bright Research Partners
EmStop Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Clinical & Angiographic Inclusion Criteria 1. Between 21 and 90 years of age at the time of consent 2. Meets FDA approved indications for transcatheter aortic valve replacement (TAVR) procedure on a native aortic valve using a commercially available Abbott or Medtronic transcatheter heart valve 3. Willing and able to provide written informed consent and written HIPAA authorization prior to initiation of study procedures 4. Willing and able to comply with the protocol-specified procedures and assessments 5. Subject anatomy is compatible with correct device deployment and positioning with: * Ability to achieve access with a 21 French equivalent femoral access sheath * Ascending aorta length ≥8 cm * Ascending aorta/aortic arch diameter is ≥25 or ≤40 mm * Ascending aorta or aortic arch exhibits ≤ Grade 1 atheromatous disease and limited wall calcification
Exclusion criteria
1. Requires urgent or emergent TAVR procedure 2. Contraindicated to MRI 3. Previously implanted aortic or mitral valve bioprosthesis 4. Hepatic failure (Child-Pugh class C) 5. Hypercoagulable state that cannot be corrected by additional periprocedural heparin 6. Planned to undergo any other cardiac surgical or interventional procedure (e.g., concurrent coronary revascularization) during the TAVR procedure or within 30 days prior to the TAVR procedure. NOTE: Diagnostic cardiac catheterization is permitted up until baseline MRI is obtained. Once baseline MRI is obtained, no additional intra-aortic or intracardiac procedure may occur. 7. Acute myocardial infarction within 30 days of the planned index procedure 8. Renal failure, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min 9. Documented history of stroke or TIA within the prior 6 months, or any prior stroke with a permanent major disability or deficit (NIHSS \>1 at baseline) 10. Left ventricular ejection fraction ≤30% within 3 months prior to procedure 11. History of intolerance, allergic reaction, or contraindication to any of the study medications, including heparin, aspirin, clopidogrel, or a sensitivity to contrast media or anesthesia that cannot be adequately pre-treated 12. Known allergy or sensitivity to nickel-titanium 13. Active endocarditis or ongoing systemic infection, defined as fever (\>38°C) and/or white blood cell (WBC) \>15,000 IU 14. Undergoing therapeutic thrombolysis 15. History of bleeding diathesis or a coagulopathy 16. Known or suspected to be pregnant, or is lactating; female subjects of child-bearing potential must have a negative serum or urine pregnancy test within 48 hours prior to the index study procedure. 17. Currently participating in another drug or device clinical study 18. Any other clinical reason, as deemed by the investigators of the study, by which the patient would not be an appropriate candidate for the study 19. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Procedural Success | During the procedure | Defined as successful insertion, deployment, positioning, and removal of the EmStop System in the absence of device interference |
| Occurrence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days | 30 days follow-up | Defined as composite of the VARC-2 defined components (all-cause mortality, all stroke (disabling and non-disabling), acute kidney injury stage 2 or 3 (including renal replacement therapy) within 72 hours) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Number of Captured Embolic Debris | During the procedure | Device filters were shipped to an independent pathology core laboratory where debris were counted and assessed |
| Average Number of Captured Particles ≥140 μm in Diameter | Procedural | Assessed by an independent pathology core laboratory |
| Total Acute Infarct Burden | 14 days pre-procedure to 18-36 hours post-procedure | As measured by diffusion-weighted imaging (DWI), also referred to as DW-MRI. A baseline DW-MRI was collected and evaluated in comparison to the post-procedure DW-MRI. |
| Occurrence of Transient Ischemic Attack (TIA) | 30 days | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EmStop Embolic Protection System Transcatheter aortic valve replacement (TAVR) procedures with the EmStop Embolic Protection System (EmStop System).
The EmStop Embolic Protection System (EmStop System): The EmStop Embolic Protection System (EmStop System) is a catheter-based filter system that captures and removes debris dislodged during transcatheter aortic valve replacement (TAVR) procedures. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | EmStop Embolic Protection System |
|---|---|
| Age, Continuous | 79.07 years STANDARD_DEVIATION 5.54 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 15 |
| other Total, other adverse events | 4 / 15 |
| serious Total, serious adverse events | 6 / 15 |
Outcome results
Primary
Number of Participants With Procedural Success
Defined as successful insertion, deployment, positioning, and removal of the EmStop System in the absence of device interference
Time frame: During the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EmStop Embolic Protection System | Number of Participants With Procedural Success | 14 Participants |
Primary
Occurrence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days
Defined as composite of the VARC-2 defined components (all-cause mortality, all stroke (disabling and non-disabling), acute kidney injury stage 2 or 3 (including renal replacement therapy) within 72 hours)
Time frame: 30 days follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EmStop Embolic Protection System | Occurrence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days | All-cause mortality | 1 Participants |
| EmStop Embolic Protection System | Occurrence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days | All stroke (disabling and non-disabling) | 1 Participants |
| EmStop Embolic Protection System | Occurrence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days | Acute kidney injury stage 2 or 3 (including renal replacement therapy) within 72 hours | 0 Participants |
Secondary
Average Number of Captured Embolic Debris
Device filters were shipped to an independent pathology core laboratory where debris were counted and assessed
Time frame: During the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EmStop Embolic Protection System | Average Number of Captured Embolic Debris | 3169.00 total number of captured particles | Standard Deviation 2059.3 |
Secondary
Average Number of Captured Particles ≥140 μm in Diameter
Assessed by an independent pathology core laboratory
Time frame: Procedural
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EmStop Embolic Protection System | Average Number of Captured Particles ≥140 μm in Diameter | 3169.00 total number of captured particles | Standard Deviation 2059.3 |
Secondary
Occurrence of Transient Ischemic Attack (TIA)
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EmStop Embolic Protection System | Occurrence of Transient Ischemic Attack (TIA) | 0 Participants |
Secondary
Total Acute Infarct Burden
As measured by diffusion-weighted imaging (DWI), also referred to as DW-MRI. A baseline DW-MRI was collected and evaluated in comparison to the post-procedure DW-MRI.
Time frame: 14 days pre-procedure to 18-36 hours post-procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EmStop Embolic Protection System | Total Acute Infarct Burden | 14.93 lesions | Standard Deviation 12.62 |