Controlled Arterial Protection to Ultimately Remove Embolic Material
Phase: NA
Conditions: Aortic Valve Stenosis
Sponsor: EmStop Inc

EmStop, Inc. 
 Document ID: EMS-CL-5000 
CAPTURE-1 Clinical Study Protocol 
Revision: B 
EmStop Embolic Protection System 
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EmStop, Inc. 
CAPTURE-1: Controlled Arterial Protection to Ultimately 
Remove Embolic Material  
Clinical Study Protocol 
Protocol Number: EMS-CL-5000 
Revision: B (10Oct2023) 
ClinicalTrials.gov NCT Number: NCT06103591
EmStop, Inc. 
1080 Green Gables Road 
Brainerd, MN 56401 USA 
Phone: 320-420-1992 
THIS STUDY PROTOCOL CONTAINS CONFIDENTIAL INFORMATION FOR USE BY THE INVESTIGATORS 
AND THEIR DESIGNATED REPRESENTATIVES PARTICIPATING IN THE STUDY. IT SHOULD BE HELD 
CONFIDENTIAL AND MAINTAINED IN A SECURE LOCATION. IT SHOULD NOT BE COPIED OR MADE 
AVAILABLE FOR REVIEW BY ANY UNAUTHORIZED PERSON OR FIRM. 

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CAPTURE-1 Clinical Study Protocol 
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Sponsor Signatures 
Signature: 
Date: 
Sponsor 
Scott Thome, Chief Executive Officer, EmStop, Inc. 
Signature: 
Date: 
Study Director (CRO) 
Emily Vollbrecht, Assoc. Study Director, BRIGHT Research Partners 
Signature: 
Date: 
Statistician (CRO) 
Scott Brown, PhD, Chief Scientific Strategist, BRIGHT Research Partners 
10/10/2023
10/5/2023
10/10/2023

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CAPTURE-1 Clinical Study Protocol 
 
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EmStop, Inc. 
CLINICAL STUDY PROTOCOL SYNOPSIS 
EmStop Study Number: EMS-CL-5000 
Study Title 
CAPTURE-1: Controlled Arterial Protection to Ultimately Remove Embolic 
Material 
Identifying 
Regulatory Numbers 
FDA IDE number – G220288 
 
Study Objective 
The objective of this study is to demonstrate safety and investigate performance 
of the EmStop Embolic Protection System when used as indicated. 
Device Description 
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. The EmStop System is composed 
of a preloaded introducer sheath, delivery catheter, and filter sheath. 
Proposed Device 
Indications for Use 
The EmStop Embolic Protection System is indicated for use as an embolic 
protection device to capture and remove thrombus/debris while performing 
transcatheter aortic valve replacement procedures. The diameters of the aorta 
at the site of filter placement should be between 25 – 40 mm. 
Study Design 
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. 
Number of Sites & 
Subjects 
The study will be conducted in up to 2 investigational sites in the U.S. This 
study will enroll up to 15 subjects. 
Study Population 
The population for this study is subjects with severe native aortic valve stenosis 
who meet clinically approved indications for TAVR. The investigation population 
aligns with the EmStop System proposed indications. 
The study will be conducted in adult subjects and does not include any other 
age, gender, or racial and ethnic origin restrictions.  
Primary Safety and 
Performance 
Endpoints 
The primary safety endpoint for the study is the occurrence of MACCE at 30 
days, defined as a composite of the following VARC-2 defined components: 
• 
All-cause mortality 
• 
All stroke (disabling and non-disabling)  
• 
Acute kidney injury (AKI) Stage 2 or 3 (including renal replacement 
therapy) within 72 hours 
The primary performance endpoint for the study is device procedural success, 
defined as successful insertion, deployment, positioning, and removal of the 
EmStop System in the absence of device interference. 

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CAPTURE-1 Clinical Study Protocol 
 
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EmStop, Inc. 
CLINICAL STUDY PROTOCOL SYNOPSIS 
EmStop Study Number: EMS-CL-5000 
Secondary 
Endpoints 
The following secondary endpoints will be evaluated: 
• 
Gross and histologic evaluation of captured embolic debris, including 
particle presence, count, size, and composition (assessed by an 
independent pathology core laboratory) 
• 
Average number of captured particles ≥140 μm in diameter (assessed 
by an independent pathology core laboratory) 
• 
Total acute infarct burden, as measured by diffusion-weighted imaging 
(DWI) within 14 days pre-procedure and at 18-36 hours post-procedure 
(assessed by an independent reader). This outcome will be evaluated 
and tabulated to include total lesion count, average (mean) lesion 
volume and median lesion volume. 
• 
Occurrence of Transient Ischemic Attack (TIA) 
Study Eligibility 
Criteria 
Patients must meet all the following inclusion criteria: 
Clinical 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 
Angiographic Inclusion Criteria (assessed via computed tomography) 
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 
Patients must not meet any of the following exclusion criteria: 
1. Requires urgent or emergent TAVR procedure 
2. Contraindicated to MRI 

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CAPTURE-1 Clinical Study Protocol 
 
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EmStop, Inc. 
CLINICAL STUDY PROTOCOL SYNOPSIS 
EmStop Study Number: EMS-CL-5000 
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 

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CAPTURE-1 Clinical Study Protocol 
 
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EmStop, Inc. 
CLINICAL STUDY PROTOCOL SYNOPSIS 
EmStop Study Number: EMS-CL-5000 
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) 
Study Duration 
Enrollment is expected to take approximately 3 months. Each study subject will 
actively participate in the study through 30-day follow-up. The overall study 
duration, from screening the first patient to the final follow-up visit, data 
analysis, and final report, is expected to be approximately 6-9 months. 
Study Sponsor 
EmStop, Inc. 
Detailed contact information is maintained in a separate Sponsor Contact 
List managed by the CRO 
 
Contract Research 
Organization (CRO) 
BRIGHT Research Partners 
730 2nd Avenue South, Suite 500 
Minneapolis, MN 55402 
Telephone: 612-345-4544 (general office line) 
www.brightresearchpartners.com 
Pathology Core Lab 
CVPath Institute 
19 Firstfield Road 
Gaithersburg, MD 20878 
Telephone: 301-208-3570 
 
 
 
 
 
 
 
 
 
 
 

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CAPTURE-1 Clinical Study Protocol 
 
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TABLE OF CONTENTS 
Angiographic Inclusion Criteria (assessed via computed tomography) ................................ 4 
1.0 
ABBREVIATIONS .........................................................................................................11 
2.0 
CLINICAL BACKGROUND ............................................................................................12 
3.0 
TREATMENT DESCRIPTION .......................................................................................13 
3.1 
Device Description .....................................................................................................13 
3.1.1 
Introducer sheath ...............................................................................................13 
3.1.2 
Delivery catheter ................................................................................................13 
3.1.3 
Filter sheath .......................................................................................................14 
3.1.4 
Device Manufacturer ..........................................................................................15 
3.1.5 
Device Labeling / Instructions for Use ................................................................15 
3.2 
Principle of Operation / Mechanism of Action ............................................................16 
3.3 
Proposed Indications for Use .....................................................................................16 
4.0 
OBJECTIVE ..................................................................................................................16 
5.0 
ENDPOINTS .................................................................................................................16 
5.1 
Primary Safety Endpoint ............................................................................................16 
5.2 
Primary Performance Endpoint ..................................................................................17 
5.3 
Secondary Endpoints .................................................................................................17 
5.4 
Ancillary Measures ....................................................................................................17 
5.5 
Rationale for Study Endpoints ...................................................................................17 
6.0 
STUDY DESIGN ...........................................................................................................18 
6.1 
Overall Design ...........................................................................................................18 
6.2 
Number of Sites & Subjects .......................................................................................18 
6.3 
Study Population .......................................................................................................18 
6.4 
Study Duration ...........................................................................................................18 
6.5 
Subject Eligibility Criteria ...........................................................................................18 
6.5.1 
General Inclusion Criteria ...................................................................................18 
6.5.2 
Angiographic Inclusion Criteria (assessed via computed tomography) ...............19 
6.5.3 
General Exclusion Criteria .................................................................................19 
7.0 
STUDY METHODOLOGY .............................................................................................20 
7.1 
Screening Visit ...........................................................................................................23 

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7.2 
Informed Consent Process ........................................................................................23 
7.2.1 
Vulnerable Population ........................................................................................23 
7.3 
Point of Enrollment & Numbering of Study Subjects ..................................................24 
7.4 
Baseline Visit .............................................................................................................24 
7.5 
Treatment Visit ..........................................................................................................24 
7.6 
Pre-Discharge............................................................................................................25 
7.7 
30-Day [± 7 days] Follow-up Visit ...............................................................................25 
7.8 
Unscheduled Visits ....................................................................................................25 
7.9 
Early Withdrawal/Premature Discontinuation of Subjects ...........................................25 
7.10 
Handling Subjects Lost to Follow-Up .........................................................................26 
7.11 
Handling of Samples Obtained from Subjects ............................................................26 
8.0 
STATISTICAL METHODS .............................................................................................26 
8.1 
Analysis Data Sets ....................................................................................................26 
8.2 
General Statistical Principles .....................................................................................26 
8.3 
Analysis of Primary Safety Endpoint ..........................................................................27 
8.4 
Analysis of Primary Performance Endpoint ................................................................27 
8.5 
Analysis of Secondary Endpoints ..............................................................................27 
8.6 
Safety Analysis ..........................................................................................................27 
8.7 
Subgroup Analysis: Learning Curve ...........................................................................27 
8.8 
Sample Size ..............................................................................................................27 
8.9 
Statistical Analysis Plan .............................................................................................28 
9.0 
MEASURES TO AVOID & MINIMIZE BIAS ...................................................................28 
9.1 
Medical Monitor .........................................................................................................28 
10.0 
BENEFITS & RISK ANALYSIS ......................................................................................28 
10.1 
Potential Benefits of Study Participation ....................................................................28 
10.2 
Alternative Treatment ................................................................................................28 
10.3 
Potential Risks Associated with Study Participation ...................................................29 
10.4 
Methods to Minimize Risks ........................................................................................29 
10.5 
Benefit-to-Risk Rationale ...........................................................................................29 
11.0 
ADVERSE EVENTS ......................................................................................................29 
11.1 
Adverse Event Definitions ..........................................................................................29 
11.2 
Adverse Event Collection & Documentation ...............................................................30 
11.2.1 
Device Deficiencies ............................................................................................30 

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CAPTURE-1 Clinical Study Protocol 
 
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11.3 
Adverse Event Reporting Timeframes .......................................................................30 
11.4 
Adverse Event Relatedness.......................................................................................31 
12.0 
ADMINISTRATIVE PROCEDURES ..............................................................................31 
12.1 
Records & Reports ....................................................................................................31 
12.1.1 
Case Report Forms ............................................................................................31 
12.1.2 
Sponsor / CRO Study Records & Reports ..........................................................31 
12.1.3 
Investigator Study Records ................................................................................32 
12.1.4 
Investigator Reporting Requirements .................................................................32 
12.1.5 
Record Storage & Retention ..............................................................................33 
12.2 
Data Management .....................................................................................................33 
12.3 
Device Accountability .................................................................................................34 
12.4 
Site Qualification & Selection .....................................................................................34 
12.5 
Site Training ..............................................................................................................34 
12.6 
Site Monitoring ...........................................................................................................35 
12.7 
Institutional Review Board (IRB) ................................................................................35 
12.8 
Protocol Deviations ....................................................................................................35 
12.9 
Protocol Amendments ...............................................................................................36 
12.10 
Study Suspension or Termination ..........................................................................36 
12.11 
Subject Confidentiality ...........................................................................................36 
12.12 
Audits & Inspections ..............................................................................................37 
12.13 
Statements of Compliance .....................................................................................37 
12.14 
Finance & Agreements ..........................................................................................37 
12.15 
Publications & Public Disclosure ............................................................................37 
12.16 
Study Contacts ......................................................................................................37 
13.0 
DEFINITIONS ................................................................................................................37 
13.1 
Adverse Event Definitions ..........................................................................................37 
13.2 
Other Study-Specific Definitions ................................................................................39 
14.0 
REFERENCES ..............................................................................................................39 
15.0 
REVISION HISTORY ....................................................................................................40 
 
 
 

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LIST OF FIGURES 
Figure 1: EmStop Embolic Protection System ...........................................................................13 
Figure 2: Introducer Sheath.......................................................................................................13 
Figure 3: Delivery Catheter .......................................................................................................14 
Figure 4: Filter Sheath ...............................................................................................................14 
Figure 5: EmStop Filter .............................................................................................................15 
Figure 6: Study Flow Diagram ...................................................................................................21 
 
LIST OF TABLES 
Table 1: EmStop Embolic Protection System Specifications .....................................................15 
Table 2: Schedule of Study Activities ........................................................................................22 
Table 3: Investigator Reporting Requirements ..........................................................................33 
 
 

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1.0 
ABBREVIATIONS 
The following is a list of abbreviations used in the body of this document. Abbreviations solely 
used in tables (e.g., table headers) are described in the table footer and are not included below. 
ADE 
Adverse device effect 
AE 
Adverse event 
AS 
Aortic valve stenosis 
CFR 
Code of federal regulations (U.S.) 
CRF 
Case report form 
(e)CRF 
(electronic) case report form 
CRO 
Contract Research Organization 
DWI 
Diffusion-weighted imaging  
EDC 
Electronic data capture database 
FDA 
Food and Drug Administration (U.S.) 
GCP 
Good clinical practice 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed consent form 
ICH 
International Conference on Harmonization 
IFU 
Instructions for use 
IRB 
Institutional review board 
ISO 
International Organization for Standardization 
MoCA 
Montreal cognitive assessment 
mRS 
Modified Rankin Scale 
NIHSS 
National Institute of Health Stroke Scale 
PI 
Principal investigator 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
SAVR 
Surgical aortic valve replacement 
TAVR 
Transcatheter aortic valve replacement 
UADE 
Unanticipated (serious) adverse device effect 
 
 
 

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2.0 
CLINICAL BACKGROUND 
Aortic valve stenosis (AS) is a common condition in which the aortic heart valve thickens and 
calcifies, preventing it from opening fully. This dysfunction limits blood flow from the heart to the 
rest of the body and leads to significant left ventricular hypertrophy. Untreated AS leads to heart 
failure, syncope, stroke, sudden cardiac arrest, and premature death. Treatment requires 
mechanical replacement of the diseased valve as there is no medical therapy. 
Treatment of severe AS has traditionally been performed by cardiac surgeons with surgical 
aortic valve replacement (SAVR). This open-heart surgery requires complete cardiac arrest and 
cardiopulmonary bypass. Because of the magnitude of the procedure, higher risk patients with 
aortic stenosis are frequently not candidates for SAVR. 
Transcatheter aortic valve replacement (TAVR), a minimally invasive procedure that uses 
catheter-based systems to percutaneously deliver self-expanding and balloon-expanding heart 
valves, was approved by the FDA in 2011. While this minimally invasive approach has 
revolutionized treatment methods for high-risk surgical patients who have aortic valve stenosis, 
there are risks associated with the use of large-bore catheters in the cardiovascular system. 
Even with recent technological advances, periprocedural stroke remains a devastating 
complication that significantly impacts mortality (Shimamura). This risk has been of increased 
concern since 2016, when TAVR was expanded to include intermediate risk patients. The 
average age of patients undergoing the TAVR procedure was found in a meta-analysis of 31 
studies to be 81.5 years with a standard deviation of 7.0 years (Chakos), while the average age 
of patients undergoing the TAVR procedure in the large PARTNER trial was 84.0 years with a 
standard deviation of 7.2 years (Kapadia).  
During the TAVR procedure, cerebral emboli have been shown to originate from atheromatous 
plaques within the aorta and from the degenerate stenotic aortic valve itself. An analysis on 
3,687 subjects from the CoreValve (Medtronic) U.S. Extreme Risk and High Risk Pivotal Trials 
and Continued Access Registry reported a stroke rate of 4.1% in the first 10 days post-TAVR 
(Kleiman). The PARTNER trial, which evaluated the Sapien device (Edwards Lifesciences) in 
2,621 subjects, reported cerebrovascular events in 3.8% at 30 days (Kapadia). This data 
illustrates the clinical need for embolic protection, which may have a significant role to play in 
the continued safety and adoption of TAVR as a treatment, especially for the intermediate risk 
patient population for which TAVR is currently being offered. 
Several embolic protection devices are in different stages of investigation in the U.S. 
PROTECTED TAVR is a landmark randomized control clinical trial currently underway 
comparing non-embolic protected TAVR to embolic protected TAVR using the Sentinel device 
(Boston Scientific, Inc.), which is the only embolic protection device currently cleared by FDA. 
The embolic protection products that are currently approved or under investigation are stand-
alone from the TAVR systems that require separate procedures with separate anatomical 
access points, thus increasing the complexity and risk. The investigational device is intended to 
provide a transformative development in the safety and ease of use of embolic protection 

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products by providing full cerebral protection using a technology platform that is integrated into 
the normal workflow of the TAVR procedure. 
3.0 
TREATMENT DESCRIPTION 
3.1 
Device Description 
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. The EmStop System is composed of a preloaded introducer sheath, delivery 
catheter, and filter sheath (Figure 1), as described below. Refer to Table 1 for system 
specifications. 
• 
Figure 1: EmStop Embolic Protection System 
 
  
3.1.1 Introducer sheath  
The introducer sheath is a single lumen, braid-reinforced catheter used to gain access to the 
vasculature and to facilitate placement and removal of the filter sheath and delivery catheter 
(Figure 2). The proximal end of the introducer sheath comprises a hub with Tuohy Borst cap 
and a one-way stopcock for flushing. 
Figure 2: Introducer Sheath 
 
3.1.2 Delivery catheter  
A single lumen, braid-reinforced catheter that facilitates delivery of the filter sheath into the 
aortic arch and controls deployment of the filter via internal actuation wires and a thumb slider 

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interface on the proximal handle (Figure 3). The distal end of the delivery catheter handle 
contains release clips for connection with the filter sheath. The delivery catheter has a 
radiopaque distal tip and a nonradiopaque (yellow) marking on the shaft to identify the shaft 
outside diameter (OD) transition; the force required to remove the device changes at this 
transition. A Luer connector on the proximal end of the handle is used for flushing. 
Figure 3: Delivery Catheter 
 
 
3.1.3 Filter sheath  
The filter sheath is a single lumen, braid reinforced catheter with a distal filter (Figure 4). This 
sheath provides a central lumen that allows for passage of TAVR devices. The proximal hub 
contains a hemostasis valve to allow for connection with the delivery catheter and passage of 
the TAVR system. The one-way stopcock allows for filter sheath flushing. The filter sheath shaft 
has a blue depth marker to indicate when the filter has been “sheathed” and a yellow depth 
marker to indicate an approximate 1” zone (at the transition between the filter and the shaft) 
where higher resistance is expected during sheath removal. 
Figure 4: Filter Sheath 
 
 
The distal end of the filter sheath has an attached filter, which is retained in a low-profile delivery 
state by the actuation wires. During deployment of the filter sheath, the actuation wires are 
operated via the thumb slider on the delivery catheter handle. The filter is composed of an 
exterior self-expanding nitinol braid and an interior attached nylon mesh (Figure 5). 

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Figure 5: EmStop Filter 
 
 
Table 1: EmStop Embolic Protection System Specifications 
Aorta size compatibility 
25 - 40 mm 
TAVR delivery system 
compatibility 
• Abbott FlexNav Delivery System  
(14F equivalent, 6.00 mm capsule outer diameter) 
• Medtronic CoreValve EnVeo PRO Delivery System  
(14F equivalent, 6.00 mm capsule outer diameter) 
• Medtronic CoreValve Evolut PRO+ Delivery System  
(14F equivalent, 6.00 mm capsule outer diameter) 
Working length 
(delivery catheter & filter sheath) 
90.17 cm (35.5 in) 
Guidewire compatibility 
0.035”, 260 cm, high support  
Introducer sheath size 
21F  
Introducer sheath working length 
43.5 cm 
Delivery catheter  
18F OD, 0.035” ID 
Filter sheath ID 
18.5F  
Filter pore size 
140 µm  
 
The device is provided to users in its delivery state, as shown in Figure 1 above. A packaging 
mandrel is placed in the distal tip and the system is packaged on a backer card, sealed within a 
single sterile barrier Tyvek pouch, and placed into a shelf box. The EmStop Embolic Protection 
System is sterilized by ethylene oxide (EtO). 
3.1.4 Device Manufacturer 
The EmStop System is manufactured for the study sponsor by Resolution Medical (Fridley, MN, 
USA). 
3.1.5 Device Labeling / Instructions for Use 
The device instructions for use will be included with the investigational product.  

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3.2 
Principle of Operation / Mechanism of Action 
The EmStop System provides embolic protection during TAVR procedures while preserving 
virtually the same sequence and number of steps as unprotected TAVR. The EmStop System 
contains a central lumen for TAVR device insertion, which eliminates the need for a concomitant 
vascular entrance point. 
After femoral access is obtained and the guidewire is advanced to the targeted location, the 
EmStop System is loaded onto the guidewire and advanced to the targeted location. Next, the 
filter sheath is advanced under fluoro guidance, and the filter is deployed in the target location 
within the ascending aorta (i.e., between the innominate takeoff and the aortic valve; the specific 
location may vary from patient to patient). The TAVR device is inserted through the EmStop 
System, and the procedure is conducted per the TAVR device IFU. After the TAVR procedure, 
the EmStop device is withdrawn, and the emboli captured in the filter is removed from the 
patient. 
The EmStop expanded filter provides filtration, collection, and removal of emboli liberated into 
the proximal aorta during the TAVR procedure. The filter is deployed in the ascending aorta 
proximal to any branch artery, thus protecting the brain and vital organs from embolic damage. 
Embolic material may be aspirated through the filter sheath during the TAVR procedure. Upon 
completion of the TAVR procedure, the filter and the captured embolic material are withdrawn 
into the sheath and removed from the patient. 
3.3 
Proposed Indications for Use 
The EmStop Embolic Protection System is indicated for use as an embolic protection device to 
capture and remove thrombus/debris while performing transcatheter aortic valve replacement 
procedures. The diameters of the aorta at the site of filter placement should be between 25 – 
40mm. 
4.0 
OBJECTIVE  
The objective of this study is to demonstrate safety and investigate performance of the EmStop 
Embolic Protection System when used as indicated. 
5.0 
ENDPOINTS 
5.1 
Primary Safety Endpoint 
The primary safety endpoint for the study is the occurrence of MACCE at 30 days, defined as a 
composite of the following VARC-2 defined components: 
• 
All-cause mortality 
• 
All stroke (disabling and non-disabling)  
• 
Acute kidney injury (AKI) Stage 2 or 3 (including renal replacement therapy) within 
72 hours 

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5.2 
Primary Performance Endpoint 
The primary performance endpoint for the study is device procedural success, defined as 
successful insertion, deployment, positioning, and removal of the EmStop System in the 
absence of device interference. 
5.3 
Secondary Endpoints 
The following secondary endpoints will be evaluated: 
• 
Gross and histologic evaluation of captured embolic debris, including particle presence, 
count, size, and composition (assessed by an independent pathology core laboratory) 
• 
Average number of captured particles ≥140 μm in diameter (assessed by an 
independent pathology core laboratory) 
• 
Total acute infarct burden, as measured by diffusion-weighted imaging (DWI), also 
referred to as DW-MRI, within 14 days pre-procedure and at 18-36 hours post-
procedure (assessed by an independent reader). This outcome will be evaluated and 
tabulated to include total lesion count, average (mean) lesion volume and median lesion 
volume. 
• 
Occurrence of Transient Ischemic Attack (TIA)  
5.4 
Ancillary Measures 
Additional ancillary data to be collected and evaluated include: 
• 
Physician usability evaluation of: 
o Device usage 
o Device deployment 
o Device retrieval 
o Filter sheath advancement 
o Delivery catheter removal 
o Filter sheath removal 
• 
Filter retraction 
• 
Use of bail out procedures 
5.5 
Rationale for Study Endpoints 
Study endpoints have been selected to align with the objectives of the trial (safety and 
performance). In particular, the primary safety endpoint, occurrence of MACCE at 30 days, is 
the same as used in prior regulated investigations of similar devices, while the primary 
performance endpoint is defined in a manner to permit evaluation of deployment, usage and 
retrieval of the EmStop System. Secondary endpoints were then selected to provide additional 
information on both safety and performance, as listed above. 

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6.0 
STUDY DESIGN 
6.1 
Overall Design 
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. Results from this study will inform the 
design of larger future studies. 
6.2 
Number of Sites & Subjects 
The study will be conducted in up to 2 investigational sites in the U.S. This study will enroll up to 
15 subjects. Each site will enroll a minimum of 5 subjects and a maximum of 10 subjects.  
6.3 
Study Population 
The population for this study is subjects with severe native aortic valve stenosis who meet 
clinically approved indications for TAVR. The investigation population aligns with the EmStop 
System proposed indications. 
The study will be conducted in adult subjects and does not include any other age, gender, or 
racial and ethnic origin restrictions. Women who have known pregnancy or who are nursing are 
excluded because of the risks of radiation exposure that occurs during the TAVR procedure and 
the medications (e.g., blood thinners) that may be needed. 
6.4 
Study Duration 
Enrollment is expected to take approximately 3 months. Each study subject will actively 
participate in the study through 30-day follow-up. The overall study duration, from screening the 
first patient to the final follow-up visit, data analysis, and final report, is expected to be 
approximately 6-9 months. 
6.5 
Subject Eligibility Criteria 
6.5.1 General Inclusion Criteria 
Subjects must meet all the following inclusion criteria: 
Clinical 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 
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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 
6.5.2 Angiographic Inclusion Criteria (assessed via computed tomography) 
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  
6.5.3 General Exclusion Criteria 
Subjects must not meet any of the following 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 

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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) 
7.0 
STUDY METHODOLOGY 
Study assessments and data collection points are visually represented in Figure 6 and Table 2 
and are described below. To avoid missing data in the study, subjects should be followed for all 
regularly scheduled visits for safety and effectiveness assessments. Any reason for withdrawal 
from the study should be documented as described later in the protocol. See Section 13.0 for 
definitions of endpoint-related terms used in this section. 
Study procedures should be followed carefully as they have been designed to address any 
known or foreseeable factors that may compromise the outcome of the clinical study or the 
interpretation of results (e.g., subject baseline characteristics, concomitant medication, the use 
of other medical devices, and subject-related factors such as age, gender, or lifestyle) and 
methods for addressing these factors (e.g., subject selection, statistical analysis). 

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Figure 6: Study Flow Diagram  
                                
 
 
 
Screen TAVR 
patients
Sign informed 
consent
Screen failure
TAVR procedure 
with EmStop 
Baseline 
assessments
Point of enrollment
(when EmStop system enters the subject)
Pre-Discharge 
assessments 
30-day follow-up 
assessments
Study 
end
Inclusion/exclusion 
criteria met?
Yes
No
Prior to discharge or 7 days post-op, whichever occurs first
• 
Note: MRI (DWI and T2-FLAIR) conducted 18-36 hours 
post-procedure
• 
Note: Labs collected within 72 hours post-procedure
Gross & histological 
assessment of debris 
captured by EmStop 
(core lab)
Computed tomography (CT) is completed as part of 
the TAVR screening process
MRI (DWI and T2-FLAIR) conducted 
within 14 days of index procedure

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Table 2: Schedule of Study Activities 
 
Screening / 
Baseline 
(within 14 days  
of procedure, 
unless specified)  
Treatment 
Procedure 
Follow-Up 
Pre-Discharge1 
30 Days 
(+/- 7 days) 
Visit type ► 
Clinic 
Clinic 
Clinic 
Clinic 
Subject informed consent 
X 
 
 
 
Demographics & medical history 
X 
 
 
 
Ejection fraction2  
X 
 
 
 
Inclusion/exclusion criteria  
X 
 
 
 
Pregnancy test (serum/urine)3 
X 
 
 
 
National Institute of Health 
Stroke Scale (NIHSS) 
X 
 
X 
 
Montreal cognitive assessment  
X 
 
 
X 
Modified Rankin Scale 
X 
 
 
X 
Computed Tomography (CT) 
X4 
 
 
 
MRI (assessed by independent 
reader) 
X5 
 
X6 
 
Medication assessment 
(anticoagulants and antiplatelet 
agents only) 
X 
X 
X 
X 
Labs (GFR, troponin, CBC) 
X 
 
X7 
X8 
Device performance assessment 
 
X 
 
 
Gross & histological assessment 
of debris captured by the 
EmStop (assessed by core lab) 
 
X 
 
 
Adverse event assessment  
 
X 
X 
X 
1Assessments occur prior to discharge or 7 days post-op, whichever occurs first. 
2Will be obtained as standard of care within 3 months of procedure. If not in medical history, must be obtained prior to TAVR procedure 
per exclusion criteria. 
3If female with child-bearing potential. 
4CT is performed during TAVR screening; the images will be reviewed to confirm that angiographic eligibility criteria are met. 
5MRI (DWI and T2-FLAIR) is conducted within 14 days pre-procedure and will be assessed by an independent reader. 
6MRI (DWI and T2-FLAIR) is conducted 18-36 hours post-procedure and will be assessed by an independent reader. 
7Pre-discharge labs will be collected within 72 hours post-procedure. CBC to include RBC, hemoglobin, hematocrit, WBC, and platelets. 
8Only lab collected at 30 days is GFR. 
 

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7.1 
Screening Visit 
The study team will screen patients for the study. Screening is defined as the process of 
reviewing a patient’s medical records against the study eligibility criteria to determine if the 
patient is eligible to enroll in the study. It is expected that the medical records will contain 
adequate information to determine if a patient meets most of these criteria; this includes the 
computed tomography (CT) completed as part of the standard of care TAVR screening process. 
The investigator will visually assess the CT imaging to ensure angiographic inclusion criteria are 
met. 
If the investigator (or designee) determines the patient meets all clinical inclusion and exclusion 
criteria (except criteria verified by blood or urine testing after consent), they can be consented 
for study participation, after which all remaining non-angiographic eligibility criteria will be 
verified prior to the procedure. 
Sites will be required to maintain a screen failure log that contains rationale for subjects who 
became screen failures after consent. 
7.2 
Informed Consent Process 
Prior to enrolling subjects in this study, the site will be required to have an Institutional Review 
Board (IRB) approved informed consent form (ICF). To ensure compliance with informed 
consent requirements, the sponsor or contract research organization (CRO) must review any 
modifications made to the sponsor’s template ICF prior to IRB submission. 
Written informed consent will be obtained from the patient (or the patient’s legal representative, 
if applicable) prior to participation as a subject in the study. The investigator (or authorized 
designee) will explain the nature of the planned treatment and objectives of the study to the 
patient, along with any costs to the subject, payments for participation, and types of insurance 
provided (if applicable). The investigator will allow adequate time for the patient to read and 
review the consent form and to ask questions. When the investigator has reasonable assurance 
that the patient (or legal representative) has an acceptable level of comprehension and the 
patient (or legal representative) voluntary agrees to participate, the patient (or legal 
representative) and the investigator (or authorized designee) will sign and date the ICF.   
The site will retain the original signed ICF in the subject’s study records and will provide a copy 
of the signed ICF to the subject. The site will document the consent process (e.g., that the 
subject was consented, the date on which the consent was obtained, and that a copy of the 
signed ICF was given to the subject) in the subject’s medical records.  
Subjects will be informed of any new information that may make him/her change their mind 
about staying in the study. Subjects may be asked to sign a new ICF if this occurs. 
7.2.1 Vulnerable Population 
To preserve the ethical integrity of this study, the sponsor does not intend to enroll vulnerable 
subject populations (e.g., incarcerated persons or adults with severe cognitive challenges) in 

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this study since such populations may be coerced or compelled to participate in a clinical study 
without a full understanding or against their will these subjects should be excluded (in 
consideration of ISO 14155:2020 sections 5.7 and A.6.3). 
7.3 
Point of Enrollment & Numbering of Study Subjects 
A patient will be considered enrolled as a study subject once an investigational EmStop System 
has entered the subject. The lowest available subject number will be assigned, progressing 
sequentially for each enrolled subject thereafter. The CRO will be notified of subject enrollment 
via the electronic data capture (EDC) database. 
7.4 
Baseline Visit 
The following standard of care evaluations and study assessments will be performed at baseline 
and documented on the relevant electronic case report forms (eCRFs): 
• 
Demographics & medical history  
• 
Pregnancy test (urine/serum), if female with childbearing potential  
• 
Ejection fraction 
• 
Medication assessment (anticoagulants and antiplatelet agents only)  
• 
Labs (GFR, troponin, CBC) 
• 
MRI, including DWI and T2-FLAIR, conducted according to study MRI procedures; 
images sent to independent reader per site instructions  
o MRI is conducted within 14 days pre-procedure  
• 
National Institute of Health Stroke Scale (NIHSS) 
• 
Montreal cognitive assessment (MoCA) 
• 
Modified Rankin Scale (mRS) 
After the baseline evaluations, the general inclusion and exclusion criteria should be reviewed to 
ensure that the subject continues to be eligible for the study. 
7.5 
Treatment Visit 
The EmStop System will be prepared and flushed per the device Instructions for Use (IFU). A 
guidewire will be advanced to the ascending aorta, and the EmStop System will be loaded onto 
the proximal end of the guidewire for delivery and deployment within the ascending aorta. A 
commercially available Abbott or Medtronic transcatheter heart valve delivery catheter will be 
inserted through the EmStop System filter sheath, and the TAVR procedure will proceed 
according to standard of care. After the TAVR delivery catheter is removed, the EmStop filter 
will be collapsed into the in-line sheath and the EmStop System will be removed.  
The assessments described below will be performed and results will be recorded on the 
relevant eCRFs. 

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• 
Adverse event assessment 
• 
Device performance assessment 
• 
Medication assessment (anticoagulants and antiplatelet agents only)  
• 
Debris captured by the EmStop System filter will be sent for gross and histological 
assessment following the Pathology Core Lab Guidelines 
7.6 
Pre-Discharge  
Unless specified otherwise below, the following assessments will be performed before 
discharge or 7 days post-op, whichever occurs first, and documented on the relevant eCRFs: 
• 
Adverse event assessment 
• 
Medication assessment (anticoagulants and antiplatelet agents only) 
• 
MRI, including DWI and T2-FLAIR, conducted according to study MRI procedures; 
images sent to independent reader per site instructions  
o MRI is conducted 18-36 hours post-procedure 
• 
Labs (GFR, troponin, CBC) 
o Pre-discharge labs will be collected within 72 hours post-procedure 
• 
National Institute of Health Stroke Scale (NIHSS) 
7.7 
30-Day [± 7 days] Follow-up Visit 
The assessments described below will be performed, and results will be recorded on the 
relevant eCRFs. 
• 
Adverse event assessment 
• 
Medication assessment (anticoagulants and antiplatelet agents only) 
• 
Labs (GFR) 
• 
Montreal cognitive assessment (MoCA) 
• 
Modified Rankin Scale (mRS) 
At the conclusion of this follow-up visit, subjects will exit from this study via completion of the 
Study Completion eCRF. Subjects will continue to be followed by their physician per usual care.  
7.8 
Unscheduled Visits 
Assessments completed during an unscheduled visit will be recorded on the applicable eCRFs. 
7.9 
Early Withdrawal/Premature Discontinuation of Subjects 
Subjects may be withdrawn early from the study for several reasons including: 
• 
Subject death 
• 
Subject lost to follow-up 

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• 
Subject request for withdrawal (withdrawal of consent) 
• 
Adverse event 
• 
Investigator decision 
If a subject is withdrawn from the study early, a Study Completion CRF must be completed to 
describe the reason for early withdrawal. The investigator should make all attempts to conduct 
an “Early Withdrawal” visit at the time of the withdrawal from the study. If a subject has 
withdrawn consent for the study or is lost to follow-up, the completion of this visit is not 
imperative. In situations where study withdrawal is due to an adverse event, subjects will be 
followed until resolution of the adverse event or determination that the subject’s condition is 
stable. 
If a subject chooses to withdraw from the study and also withdraws consent for disclosure of 
further information, no further study assessments should be performed, and no additional data 
collected. The sponsor may retain and continue to use any data collected prior to the withdrawal 
of consent. 
7.10 
Handling Subjects Lost to Follow-Up 
Every attempt must be made to have all subjects complete the follow-up visit schedule. A 
subject will be considered lost-to-follow-up when all efforts to obtain compliance are 
unsuccessful. At a minimum, the effort to obtain follow-up information must include three 
attempts to make contact via telephone, and if contact via phone is not successful, a certified 
letter from the principal investigator (PI) or authorized delegate must be sent to the subject’s last 
known address. Both telephone and letter contact efforts to obtain follow up must be 
documented in the subject’s medical records and on the Study Completion eCRF. 
7.11 
Handling of Samples Obtained from Subjects 
No subject samples will be retained by the sponsor.  
8.0 
STATISTICAL METHODS 
8.1 
Analysis Data Sets 
The primary analysis will consist of all available data on all subjects enrolled, referred to in ICH 
E9 (“Statistical Principles for Clinical Trials”) as the full analysis set. As the study is a treatment-
only, single arm design, summaries of results will principally be presented for the entire study 
population. 
8.2 
General Statistical Principles 
Continuous data will be summarized using the following descriptive statistics: mean, standard 
deviation, median, and range or interquartile range. Categorical variables will be summarized 
using frequency counts and percentages. For events that can occur more than once in a single 

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subject, such as adverse events (AEs), the percentage will be based on the number of subjects 
experiencing the event; both subject and event counts will be reported. 
All statistical analyses will be performed using SAS (version 9.4 or higher, SAS Institute Inc. 
Cary, NC), R (version 3.2 or higher, R Foundation for Statistical Computing, Vienna, Austria) or 
other widely accepted statistical or graphical software. 
8.3 
Analysis of Primary Safety Endpoint 
The primary safety endpoint will be summarized descriptively per the general statistical 
principles described above. The intent of this analysis is to capture, characterize, and report 
safety outcomes associated with the use of the EmStop System. 
8.4 
Analysis of Primary Performance Endpoint 
The primary performance endpoint will be summarized descriptively per the general statistical 
principles described above. The intent of this analysis is to capture, characterize and report 
performance outcomes associated with the use of the EmStop System. 
8.5 
Analysis of Secondary Endpoints 
Secondary endpoints will be summarized descriptively per the general statistical principles 
described above. 
8.6 
Safety Analysis 
Summary tables and listings will be provided for all reported adverse events, which will 
additionally be reported by seriousness and relatedness. Such summaries will comprise the 
number and percentage of subjects with an adverse event and the total number of such events. 
The proportion of subjects with events will be considered primary for analysis of adverse events. 
8.7 
Subgroup Analysis: Learning Curve 
As it is plausible that a learning curve will be observed in the use of this novel technology, to 
assess the effect of operator experience on outcomes, subgroup analyses of the primary 
endpoints distinguishing the first from all subsequent subjects per attending physician will be 
performed.  
8.8 
Sample Size 
The sample size of 15 was selected to provide clinical and statistical information, including 
assessment of point estimates, frequencies, and variability in key outcomes, to inform design 
elements of a subsequent pivotal study. 
As the objective of this investigation is to characterize outcomes under treatment, sample size is 
not driven by formal evaluations of power against predefined success criteria. Where performed, 
hypothesis testing will have one-sided tests with p-values less than 0.025 deemed significant 
and two-sided tests with p-values less than 0.05 deemed significant. 

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8.9 
Statistical Analysis Plan 
Refer to the Statistical Analysis Plan (SAP) for details on statistical design, method and 
analytical procedures including testing of poolability across clinical sites and handling of missing 
data. 
9.0 
MEASURES TO AVOID & MINIMIZE BIAS 
The study has several measures that have been implemented to avoid and minimize bias, 
including the following: use of an independent CRO for study operations management, 
monitoring, and data management; identification of an independent medical monitor; and use of 
an independent pathology core laboratory and independent MRI reader for systematic review of 
the debris captured by the EmStop System and study MRIs, removing any potential for 
investigator bias. 
9.1 
Medical Monitor 
A Medical Monitor with clinical expertise in TAVR procedures will oversee and evaluate safety 
events to provide formal safety monitoring and independent, objective expert counsel for this 
feasibility study. The Medical Monitor will follow pre-specified guidelines to adjudicate AEs and 
adjudicate them for seriousness and relatedness. In addition, the Medical Monitor may advise 
the sponsor regarding the continuing safety of study subjects and those yet to be recruited. 
Sites will be expected to provide supporting source documentation, as requested, to assist the 
Medical Monitor with evaluation of safety-related events. Core Laboratory 
A pathology core laboratory will be used to provide an unbiased assessment of debris samples 
collected for processing and analysis. The pathology core laboratory will provide shipping and 
processing instructions to the sites. The pathology core laboratory will follow its own charter or 
similar procedure to systematize their image review in compliance with the study protocol. 
10.0 BENEFITS & RISK ANALYSIS 
10.1 
Potential Benefits of Study Participation 
There are no guaranteed benefits from participation in this study; however, it is possible that 
treatment with a study device may have the following benefits: 
• 
Reduced risk of stroke 
10.2 
Alternative Treatment 
There is no obligation for a patient to take part in this study. Alternative treatments may include: 
• 
TAVR without embolic protection 
• 
TAVR with embolic protection using a commercially available device (e.g., Boston 
Scientific SENTINEL) 

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10.3 
Potential Risks Associated with Study Participation 
As with any percutaneous coronary procedure, use of the study devices during TAVR involves 
some risks. Risks associated with laboratory testing (i.e., blood draws) and the TAVR procedure 
will be listed in the site’s procedure consent form used per their standard of care. Potential risks 
associated with the EmStop System may include but are not limited to: 
• 
Acute kidney injury (AKI) 
• 
Atrial fibrillation (new or worsening)  
• 
Bleeding (life-threatening, major, minor) 
• 
Death 
• 
Periprocedural myocardial infarction (MI) 
• 
Stroke 
• 
Transient ischemic attack (TIA) 
• 
Vascular or access-related complications 
The frequency and severity of adverse events can vary, and may necessitate additional medical 
intervention, including surgery. 
10.4 
Methods to Minimize Risks 
The EmStop System was subjected to a risk assessment as part of the design control process. 
Results of pre-clinical bench and laboratory testing have demonstrated that the device is likely 
to be safe and perform as intended in clinical use.   
During this study, risks will be further minimized through careful subject screening and selection, 
training of investigators and study staff, adherence to the scheduled assessments, and regular 
monitoring visits.  
10.5 
Benefit-to-Risk Rationale 
The results from risk analysis and risk mitigation measures support reasonable assurance of the 
safety and efficacy of the EmStop System when used in a manner consistent with its labeling 
and intended use. The evidence supporting safety and effectiveness of the EmStop System is 
based on robust pre-clinical bench and laboratory testing, as well as the clinical experience of 
similar TAVR embolic protection products, such as the market-released SENTINEL (Boston 
Scientific). The evidence supports a clinical benefit-to-risk determination that is favorable for the 
EmStop System. 
11.0 ADVERSE EVENTS 
11.1 
Adverse Event Definitions 
Adverse events will be adjudicated for seriousness and for relatedness to the investigational 
device and study procedure. Refer to Section 13.0 for adverse event definitions. 

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11.2 
Adverse Event Collection & Documentation 
Collection of adverse events will start on the day of the procedure for enrolled subjects and will 
be assessed and reported throughout the study. Investigators must obtain all information 
available to determine the seriousness, relatedness, and outcome of the adverse event and to 
assess whether it meets the criteria for classification as an unanticipated adverse device effect 
(UADE) requiring immediate notification. All adverse events will be followed until resolution or 
investigator determination that the subject’s condition is stable. 
All reported adverse events will be documented on the Adverse Event CRF. Copies of de-
identified source documentation that contain significant information related to the event, such as 
progress notes, consultations, nurse notes, operative reports, and subject summaries may be 
requested by the sponsor, CRO, Medical Monitor and/or core lab as needed for evaluation and 
adjudication.  
The following are not considered reportable adverse events for this study: 
• 
Any normal expected postoperative complaints or symptoms unless the event involves 
a clinically significant change in severity or duration of symptoms or requires clinical 
intervention that is different from ordinary postoperative care. Expected postoperative 
complaints and findings include, but are not limited to headache, edema, nausea, 
vomiting, and postoperative pain (excluding chest pain). 
• 
Any condition that is recorded as pre-existing at baseline, unless there is a worsening of 
that condition in terms of nature, severity, or degree of incidence. 
• 
Planned hospitalization for pre-existing conditions or a procedure required by the 
protocol, without serious deterioration in health.  
In case of subject death, it is requested that a copy of the death certificate and a copy of the 
autopsy report, if applicable, be sent to the CRO. Any other source documents related to the 
death should also be provided to the CRO. If no source documents are available, the PI is 
required to describe the circumstances of the subject’s death in written communication (e.g., 
letter, e-mail). 
11.2.1 Device Deficiencies  
Device performance, including deficiencies, will also be collected. If a device deficiency results 
in the subject experiencing any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs, these outcomes will be reported as an adverse event on an Adverse 
Event CRF. Any malfunctioning devices will be returned to the sponsor by the site for further 
evaluation. 
11.3 
Adverse Event Reporting Timeframes 
The investigator is responsible for reporting serious adverse events to the IRB in accordance 
with the IRB’s procedures. Unanticipated adverse device effects (UADEs) have special 
reporting requirements for both the investigator and sponsor, as described in 21 CFR 812.150: 

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• 
Investigator Report: If a subject experiences a UADE, the investigator must notify the 
sponsor/CRO and the reviewing IRB as soon as possible, but no later than 10 working 
days after the investigator first learns of the effect. 
• 
Sponsor Report: UADEs will be reported to the FDA, all reviewing IRBs, and 
participating investigators as soon as possible, but no later than 10 working days after 
receiving notice of the UADE. 
11.4 
Adverse Event Relatedness 
The investigator and the Medical Monitor will assess the relatedness of the adverse event to the 
investigational device and the study procedure using the categories listed below (see Section 
13.0 for definitions): 
• 
Definitely 
• 
Probably 
• 
Possibly 
• 
Unlikely 
• 
Not Related 
12.0 ADMINISTRATIVE PROCEDURES 
12.1 
Records & Reports 
12.1.1 Case Report Forms 
Worksheets may be used to collect subject data that is not readily available from the source 
documentation. An electronic data capture (EDC) system will be used to collect study-required 
data on electronic CRFs (eCRFs). The principal investigator (PI) at the site is responsible for 
ensuring the eCRFs are accurate and completed in a reasonable timeframe. The PI is required 
to review and approve the eCRF on the appropriate page(s) to verify the completeness, 
accuracy, and authenticity of the recorded data.  
12.1.2 Sponsor / CRO Study Records & Reports 
The sponsor and CRO are responsible for maintaining study records and reports per applicable 
ICH good clinical practices (GCPs), FDA regulations, ISO 14155, and applicable standard 
operating procedures and study specific plans (e.g., Monitoring Plan, Data Management Plan, 
Training Plan, and Statistical Analysis Plan). 
Results on all pre-specified study outcomes will be released in interim reports, as needed, and 
in a final clinical study report that will be released within 6 months after study termination or 
completion. The release of this information, including negative outcomes, may be hastened if 
the study is terminated early. 

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12.1.3 Investigator Study Records 
The investigator will securely maintain the following accurate, complete, and current records 
relating to their participation in the study: 
• 
All essential correspondence that pertains to the investigation. 
• 
Records of each subject’s case history and exposure to the investigational device. Case 
histories include the CRFs and supporting data including, for example, signed and 
dated ICFs and medical records including, for example, progress notes of the physician, 
the individual’s hospital chart(s), and the nurses’ notes. Such records will include: 
• 
Documents evidencing the informed consent process. The case history of each 
individual will document that informed consent was obtained at the appropriate time. 
• 
All relevant observations, including records concerning adverse device effects 
(whether anticipated or unanticipated), information and data on the condition of each 
subject upon entering, and during the course of, the investigation, including 
information about relevant previous medical history and the results of all diagnostic 
tests. 
• 
A record of the exposure of each subject to the investigational device, including the 
date and time of each use, and any other therapy.  
• 
The protocol, with documents showing the dates and reasons for each deviation from 
the protocol.  
• 
Signed investigator agreements, financial disclosure agreements, investigator signature 
pages, and curriculum vitae. 
• 
IRB approval documents including approval of the protocol, protocol amendments and 
ICF. 
12.1.4 Investigator Reporting Requirements 
Investigator reporting requirements are noted in Table 3 below. 

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Table 3: Investigator Reporting Requirements  
Report 
Submitted to 
Description 
Unanticipated Adverse 
Device Effects (UADE) 
Sponsor/CRO 
& IRB 
Notification as soon as possible, but no later than 10 
working days after the investigator first learns of the 
effect. 
Device deficiency that 
might have led to a serious 
adverse event if 
appropriate action had not 
been taken, intervention 
had not occurred, or 
circumstances had been 
less fortunate 
Sponsor/CRO 
Notification without unjustified delay after the 
investigator first learns of the device deficiency that 
might have led to an SAE. 
Serious Adverse Events 
(SAE) 
IRB 
Per IRB reporting requirements 
Withdrawal of IRB approval 
Sponsor/CRO 
Notification within 5 working days of withdrawal. 
Progress Report 
Sponsor/CRO 
& IRB 
Periodic report detailing the progress of the study, 
occurring at least annually. 
Deviations from protocol 
(CFR 812.150) 
 
 
Sponsor/CRO 
& IRB 
Emergency Use: Notification must be made within 
5 working days of the occurrence of an emergency 
deviation (made to protect the life or physical well-
being of a subject). 
Other: If the deviation affects scientific soundness 
of the study or the rights, safety, or welfare of the 
subject (and is not an emergency), prior approval 
must be obtained from sponsor the reviewing IRB, 
and FDA when required. 
Failure to obtain informed 
consent 
Sponsor/CRO 
& IRB 
Notification within 5 working days  
Incomplete resheathing or 
retraction of the device or 
use of bail out procedure 
leading to device or 
procedure related adverse 
events 
Sponsor/CRO 
Notification within 24 hours following TAVR 
procedure; Sponsor must notify FDA within 5 
working days  
Final Report 
IRB 
Submitted within 3 months after termination or 
completion of the investigation. 
 
12.1.5 Record Storage & Retention 
Refer to the Clinical Trial Agreement for trial data storage, access, and retention requirements. 
12.2 
Data Management 
Correction of missing or unclear data will be requested as necessary throughout the study. The 
CRO may request additional information including source documentation as needed. The CRO 

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will also be responsible for confirming the overall integrity of the data. Refer to the study Data 
Management Plan for more details. 
12.3 
Device Accountability 
All EmStop System investigational devices will be labeled with reference (part or model) and lot 
numbers. Shipment and receipt records will be maintained, and upon receipt of the 
investigational devices, the site study coordinator (or delegate) will inventory the devices. As 
each subject receives treatment with the study device, the date of treatment, subject identifiers 
(site number/subject number), device performance assessment, and device traceability 
information will be recorded. If a study device is returned to the sponsor, the date of return and 
reason for the return shall be documented. 
The EmStop System must be stored in a secure location at each clinical site to ensure use only 
in the study and unused devices must be returned promptly upon study completion or 
termination. Product labeled as “For Investigational Use Only” must only be used in the clinical 
investigation.  
12.4 
Site Qualification & Selection 
The sponsor and/or CRO will assess each potential site to ensure the investigators and his/her 
staff meet the minimum following criteria: 
• 
The site has an interventional cardiologist that can act as a principal investigator. 
• 
The investigators are qualified by experience and training. 
• 
The site has adequate research support staff with the availability to fulfill the clinical 
study requirements specified in the protocol.  
• 
The site is not participating in another investigational study that is currently enrolling 
subjects with competing eligibility criteria; studies that have completed enrollment and 
are in the subject follow-up phase would not exclude the site from participation in this 
study. 
• 
The investigators are not on the FDA disqualified or debarred list. 
Additional details are specified in the study-specific Site Qualification Questionnaires used to 
select eligible sites. 
12.5 
Site Training 
Training of the clinical site personnel will be the responsibility of the study sponsor and the 
CRO. Site personnel will be trained per the study-specific Training Plan, which will consider 
numerous requirements including inputs from the risk assessments described in this protocol. 
All site personnel will undergo training prior to performing any study-related procedures. All 
training will be documented. Existing site personnel who have been delegated new tasks and 
new site personnel will undergo training as designated in the Training Plan.  

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12.6 
Site Monitoring 
This clinical study will be monitored according to a study-specific Monitoring Plan that complies 
with GCP. Monitors will assess for appropriate study conduct and data integrity, including review 
of eCRFs and parity checks with the source documentation, worksheets, and hospital charts. 
Periodic site visits will be conducted (either on-site or remotely), including a site initiation visit, 
routine monitoring visits, and a study closeout visit upon completion of the study. At a minimum, 
the ICF and the ICF process, primary and secondary endpoint data, and adverse event data will 
be 100% monitored and compared to source documentation. Monitoring will include comparison 
of eCRFs to source documentation for accuracy and appropriateness, study device 
accountability, review for unreported adverse events, and prompt evaluation of potential 
UADEs.  
12.7 
Institutional Review Board (IRB) 
At a minimum, the CRO must have documented IRB approval for the protocol and the site-
specific ICF prior to site activation to enroll subjects. Identification of the study (study number, 
protocol title, and version), documents approved (e.g., protocol, ICF), and the date of IRB 
review should be clearly stated on the IRB approval documentation signed by the IRB. The site 
will not be activated until a copy of written and dated IRB approval has been received by the 
CRO and other applicable study activation requirements are complete. 
The site must submit any protocol or ICF amendments to the IRB and is required to forward a 
copy of the written approval to the CRO. An IRB approval of the amended document(s) must be 
obtained before implementation and before new subjects are consented to participate in the 
study using the amended ICF, if applicable. The IRB should also be informed of any event likely 
to affect the safety of subjects or the conduct of the study. Any additional requirements imposed 
by the IRB or regulatory authority shall be followed, if appropriate. 
The ICF must be reviewed by the CRO prior to submission to the IRB for approval. 
12.8 
Protocol Deviations 
A protocol deviation is defined as a circumstance in which the investigator or other site 
personnel did not conduct the trial according to the protocol, applicable laws/regulations, or any 
study agreements (e.g., Clinical Trial Agreement, Investigator Agreement).  
Every attempt will be made to adhere to the protocol. However, should an investigator be 
required to deviate from the protocol to protect the life or physical well-being of a study subject 
in an emergent circumstance, such notice will be given to the sponsor or CRO and IRB as soon 
as possible, but no more than 5 working days from the date the emergency occurred. Except for 
an emergent circumstance, prior approval from the sponsor, the IRB, and FDA (when 
applicable) is required for any change in, or deviation from, the protocol as such changes may 
affect the scientific soundness of the protocol or the rights, safety, and welfare of study subjects.  

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Protocol deviations will be documented on the Protocol Deviation CRF. Deviations are 
reportable to the central or the institution’s governing IRB during the annual reporting process, 
unless otherwise directed by the governing IRB requirements.   
Repeated protocol deviations will be closely monitored by the CRO/sponsor. If excessive 
deviations or a failure to reduce deviations is noted, the sponsor reserves the right to suspend 
study enrollment or terminate the site from the study until a sufficient system is in place at the 
site to reduce further deviations (21 CFR 812.46(a)).   
12.9 
Protocol Amendments 
Changes to the protocol must be documented in a formal protocol amendment prior to 
implementation in the study. Amendments to the protocol will be initiated by the sponsor or CRO 
and must be approved by the IRB prior to implementation at the site. 
12.10 Study Suspension or Termination 
No formal statistical rule for early termination of this study for insufficient effectiveness of the 
study devices is defined. 
The sponsor reserves the right to terminate or suspend the study for valid scientific reasons or 
reasons related to the protection of subjects (e.g., the discovery of an unexpected, significant, or 
unacceptable risk to the subjects). The sponsor also reserves the right to terminate the study for 
business reasons. Refer to the Clinical Trial Agreement for specific information regarding study 
termination (by IRB withdrawal of approval, by principal investigator, or by sponsor).   
If the study is terminated prematurely or suspended, the sponsor will promptly inform all 
investigators of the termination or suspension and the reason(s). The IRB will also be informed, 
either by the sponsor or Investigator, and provided with the reasons(s) for the termination or 
suspension. Regulatory authorities will be informed, as required.  
The IRB may choose to discontinue the study at any site for which they granted approval if the 
research study is not conducted in accordance with the IRB’s requirements or the research 
study indicates unexpected serious harm to subjects.    
12.11 Subject Confidentiality 
All information and data sent to the CRO concerning a subject or their participation in this study 
will be considered confidential. The sponsor, CRO, monitors, IRB, and regulatory 
representatives will have access to these confidential files and have the right to inspect and 
copy all records pertinent to this study for data verification. All data used in the analysis and 
reporting of this study will be without identifiable references to a subject. Subject names and 
contact information will be available to the sponsor, CRO, and monitors during review of medical 
records. Subject names may be available to the core laboratory and Medical Monitor as they 
review study-related samples and source documentation. This information will be treated with 
adherence to professional standards of confidentiality. In addition, upon regulatory request, 
subject records shall be provided to regulatory agencies. 

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12.12 Audits & Inspections 
Investigators and study sites are required to permit study-related monitoring, audits, IRB review, 
and regulatory inspection(s) and provide direct access to source data/documents. 
12.13 Statements of Compliance 
This study is to be conducted in compliance with the study protocol and in accordance with 
ethical principles that have their origin in the Declaration of Helsinki, as defined in the following 
U.S. and international standards for good clinical practice: 
• 
International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice 
E6 (R2) (2016) 
• 
U.S. Code of Federal Regulations (CFR) regarding clinical studies (21 CFR including 
parts 11, 50, 54 and 56 and 812) and HIPAA (45 CFR 164.508) 
• 
ISO 14155: 2020 
12.14 Finance & Agreements 
For details on how the clinical investigation is financed and the agreement between the sponsor, 
investigators, and sites, refer to the Investigator Agreement and Clinical Trial Agreement. 
12.15 Publications & Public Disclosure 
Refer to the Clinical Trial Agreement for publications and public disclosure requirements and 
conditions.  
12.16 Study Contacts 
Refer to the Study Contact List for detailed contact information, including names, telephone 
numbers, and email addresses. 
13.0 DEFINITIONS 
13.1 
Adverse Event Definitions 
Adverse event (AE):  Untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, 
whether or not related to the investigational medical device and whether anticipated or 
unanticipated. [ISO 14155 2020, 3.2] 
Adverse event relatedness: The relationship of an adverse event to the investigational device 
or the study procedure based on the categories defined below. 

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Relatedness 
Description 
Definitely 
The adverse event follows a strong temporal sequence to the receipt (or attempted 
receipt) of the device treatment or procedure. This can include an adverse event that 
occurs after the study procedure. 
Probably 
The adverse event follows a reasonable temporal sequence to the receipt (or 
attempted receipt) of the device treatment or procedure, and the possibilities of other 
factors, such as underlying and concomitant illness, concomitant medications, or 
concurrent treatment can be excluded. 
Possibly 
The adverse event follows a reasonable temporal sequence from receipt (or 
attempted receipt) of the device treatment or procedure and the possibility of device 
treatment or procedure involvement cannot be excluded. However, other factors 
such as underlying or concomitant illness, concomitant medications, or concurrent 
treatment are presumable. 
Unlikely 
The adverse event has an improbable temporal sequence to the receipt (or 
attempted receipt) of the device treatment or procedure, or it can be reasonably 
explained by other factors, including underlying or concomitant illness, concomitant 
medications, or concurrent treatment. 
Not related 
The adverse event has no temporal sequence to the interventional procedure, the 
device treatment, or any user handling, or it can be explained by other factors, 
including underlying disease or concomitant illness, concomitant medication, or 
concurrent treatment. 
 
Device deficiency: Inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, usability, safety, or performance. [ISO 14155 2020, 3.19] 
• 
Note: Device deficiencies include malfunctions, use errors, and inadequacy in the 
information supplied by the manufacturer including labelling. This definition includes 
device deficiencies related to the investigational medical device or the comparator. 
Serious adverse event (SAE):  An adverse event that led to any of the following: 
• 
Death 
• 
Serious deterioration in the health of the subject, users, or other persons as defined 
by one or more of the following: 
o a life-threatening illness or injury 
o a permanent impairment of a body structure or a body function including chronic 
diseases 
o in-patient or prolonged hospitalization 
o medical or surgical intervention to prevent life-threatening illness or injury, or 
permanent impairment to a body structure or a body function, 
• 
Fetal distress, fetal death, a congenital abnormality, or birth defect including physical 
or mental impairment 

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Note: Planned hospitalization for a pre-existing condition, or a procedure required by the 
protocol, without serious deterioration in health, is not considered a serious adverse event. 
[ref. ISO 14155:2020, 3.45] 
Note: An AE is considered “life-threatening” if, in the view of either the investigator or 
sponsor, its occurrence places the subject at immediate risk of death. It does not include an 
AE that, had it occurred in a more severe form, might have caused death. 
Unanticipated adverse device effect (UADE): Any serious adverse effect on health or safety 
or any life-threatening problem or death caused by, or associated with, a device, if that effect, 
problem, or death was not previously identified in nature, severity, or degree of incidence in the 
investigational plan or application (including a supplementary plan or application), or any other 
unanticipated serious problem associated with a device that relates to the rights, safety, or 
welfare of subjects. [21 CFR 812.3(s)] 
13.2 
Other Study-Specific Definitions 
Device interference: Interaction of the EmStop System with the TAVR system that leads to: 
• 
Inability to advance or manipulate the TAVR system, or 
• 
Inability to deploy the TAVR system, or 
• 
Inability to retrieve the TAVR system 
Device procedural success: Successful insertion, deployment, positioning, and removal of the 
EmStop System in the absence of device interference. 
Major adverse cardiac and cerebrovascular events (MACCE): All-cause mortality, all stroke 
(disabling and non-disabling) and transient ischemic attack (TIA), and acute kidney injury (AKI) 
Stage 2 or 3 (including renal replacement therapy). MACCE events will be adjudicated by the 
Medical Monitor using VARC-2 definitions [Kappetein 2013]. 
Montreal cognitive assessment (MoCA): A highly sensitive tool for early detection of mild 
cognitive impairment that was validated in 2000. [https://www.mocatest.org/]  
National Institutes of Health Stroke Scale (NIHSS): A systematic assessment tool that 
provides a quantitative measure of stroke-related neurologic deficit. 
[https://www.nihstrokescale.org/]  
14.0 REFERENCES 
Chakos, A, Wilson-Smith, A, Arora, S, Nguyen, T. C, et al. Long term outcomes of transcatheter 
aortic valve implantation (TAVI): a systematic review of 5-year survival and beyond. 
Annals of cardiothoracic surgery, 2017 6(5), 432–443. 
https://doi.org/10.21037/acs.2017.09.10 
Kapadia S, Agarwal S, Miller DC, Webb J, et al. Insights into timing, risk factors, and outcomes 
of stroke and transient ischemic attack after transcatheter aortic valve replacement in the 

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PARTNER trial (Placement of Aortic Transcatheter Valves). Circ Cardiovasc Interv. 2016 
Sep;9(9):e002981. 
Kappetein A, Head S, Genereux P, Piazza N, et al. Updated standardized endpoint definitions 
for transcatheter aortic valve implantation: The Valve Academic Research Consortium-2 
consensus document. J Thorac Cardiovasc Surg. 2013;145:6-23. 
Kleiman NS, Maini BJ, Reardon MJ, Conte J, et al. Neurological events following transcatheter 
aortic valve replacement and their predictors: a report from the CoreValve trials. Circ 
Cardiovasc Interv. 2016 Sep;9(9):e003551. 
Shimamura J, Kuno T, Malik A, Yokoyama Y, et al. Safety and efficacy of cerebral embolic 
protection devices in patients undergoing transcatheter aortic valve replacement: a 
meta-analysis of in-hospital outcomes. Cardiovasc Interv Ther. 2021 Nove 13. Online 
ahead of print. 
https://link.springer.com/article/10.1007/s12928-021-00823-1 
15.0 REVISION HISTORY 
Rev. 
Description of Changes 
DCO # 
Effective Date 
A 
Initial release. 
2023-08-004 
25Aug2023 
B 
Additional ancillary data collection measures were added to 
section 5.4. Table 3 was updated to include an additional 
investigator reporting requirement if there is incomplete filter 
resheathing or use of the bailout procedure, resulting in 
procedural or device related adverse events. 
2023-10-001 
 
 
10/10/2023