Subcostal Temporary Extracardiac Pacing Study: Clinical Study of the AtaCor Extracardiac Pacing System
Phase: NA
Conditions: Conduction Defect
Sponsor: AtaCor Medical, Inc.

AtaCor Medical, Inc. 
 
Revision A 
Clinical Investigation Plan Synopsis – Subcostal Temporary Extracardiac Pacing (STEP) Study 
Excerpt of DOC-10052 
 
Page 1 of 3 
 
CONFIDENTIAL 
This document contains proprietary information.  It may not be reproduced or disclosed 
without the express written consent of AtaCor Medical, Inc. 
 
 
 
 
 
 
Synopis of Clinical Investigation Plan (CIP) 
 
Subcostal Temporary Extracardiac Pacing (STEP) Study 
 
Clinical Study of the AtaCor Extracardiac Pacing System 
 
Excerpt from DOC-10052, Revision A 
 
23 July, 2019 
 
NCT 04096365 
 
SPONSOR: 
ATACOR MEDICAL, INC. 
635 CAMINO DE LOS MARES, SUITE 205 
SAN CLEMENTE, CA 92673 
 
 

AtaCor Medical, Inc. 
 
Revision A 
Clinical Investigation Plan Synopsis – Subcostal Temporary Extracardiac Pacing (STEP) Study 
Excerpt of DOC-10052 
 
Page 2 of 3 
 
CONFIDENTIAL 
This document contains proprietary information.  It may not be reproduced or disclosed 
without the express written consent of AtaCor Medical, Inc. 
 
Synopsis of the Clinical Investigation 
Study Name 
Subcostal Temporary Extracardiac Pacing (STEP) Study 
Study 
Objectives 
To evaluate initial safety and performance of the AtaCor Temporary Pacing System.  Safety will be 
evaluated through analysis of all Adverse Events.  Performance will be evaluated through (1) the 
incidence of successful StealthTrac Lead placement using the MACH I Delivery Tool, (2) measurements 
of capture thresholds, sensed R-wave amplitudes, pacing impedance and concomitant skeletal muscle 
stimulation at rest, in multiple postures and during in-hospital ambulation, and (3) differences in cardiac 
conduction (12 lead ECG) and function (Echocardiography) while pacing with temporary transvenous 
lead, the AtaCor StealthTrac Lead and during intrinsic conduction. 
Study Size 
Up to 15 Subjects inserted with the StealthTrac Lead from a maximum of three (3) investigation sites.  
This study is not statistically-powered.  Results may be used to generate hypotheses for subsequent 
clinical investigations. 
Study 
Duration 
The total expected duration of the investigation is four (4) to six (6) months, comprising two (2) to four 
(4) months for enrollment and follow-up, plus an additional two (2) months to analyze study data and 
prepare a final report.  Subject participation consists of an in-hospital device evaluation up to seven (7) 
days and a 30-day post-removal follow-up visit to detect any latent adverse events after hospital 
discharge. 
Study Design 
Prospective, subacute (in-hospital), single-arm, multicenter 
Study 
Population 
To participate in this clinical investigation, Subjects must meet all the following criteria: 
1. Indicated for closed-chest cardiac invasive procedure with the potential for intra-procedural or 
post-procedural bradycardia and willing to be hospitalized for a minimum of 2 days post 
procedure. 
Examples of such procedures include: transfemoral transcatheter aortic valve replacement 
(TAVR), balloon valvuloplasty, permanent pacemaker implantation and pacing lead 
extractions/revisions. 
2. Physically and mentally capable of providing informed consent. 
3. At least 18 years of age or of legal age to provide consent as required by local and national 
requirements. 
To participate in this study, Subjects must not meet any the following criteria: 
1. Contraindicated or clinically unsuitable for transvenous lead placement; 
2. Implanted with an implantable cardioverter defibrillator (ICD) or transvenous defibrillation lead 
at the time of enrollment; 
3. History of a prior sternotomy (median or partial); 
4. History of prior surgery with disruption of the lung, pericardium or connective tissue between 
the sternum and pericardium; 
5. History of significant anatomic derangement of the thorax (e.g., pectus excavatum), prior chest 
radiation therapy or other reasons which may cause pericardial adhesions or complicate the 
AtaCor Temporary Pacing System insertion procedure; 
6. History of pericardial disease, pericarditis or mediastinitis; 
7. History of chronic obstructive pulmonary disease (COPD); 
8. NYHA functional classification IV at the time of enrollment; 
9. History of congenital heart disease; 
10. Patients with circumstances that prevent data collection or follow-up, including conditions that 
prevent ambulation and testing in multiple postures; 
11. BMI ≥ 35 kg/m2; 
12. History of allergies to any study device components; 
13. Pregnant or lactating (current or anticipated during study follow up); and 
14. Participation in any concurrent study without prior, written approval from the Sponsor. 

AtaCor Medical, Inc. 
 
Revision A 
Clinical Investigation Plan Synopsis – Subcostal Temporary Extracardiac Pacing (STEP) Study 
Excerpt of DOC-10052 
 
Page 3 of 3 
 
CONFIDENTIAL 
This document contains proprietary information.  It may not be reproduced or disclosed 
without the express written consent of AtaCor Medical, Inc. 
 
Figure 1 provides an 
overview 
of 
study 
activities. 
 
Enrolled 
Subjects will have a 
market-released 
transvenous pacing lead 
and 
investigational 
StealthTrac Lead placed.  
Both 
leads 
will 
be 
evaluated 
to 
confirm 
ventricular sensing and 
capture. 
Diagnostic 
echocardiograms will be 
performed to detect any 
pericardial 
effusions 
caused by inserting the 
StealthTrac Lead. The 
index procedure will be 
performed according to 
standard 
of 
care 
methods, after which the 
StealthTrac Lead will be 
used to deliver high rate 
pacing 
(160 to 
220 
BPM) 
in 
clinically 
appropriate 
Subjects.  
The 
electrical 
performance 
of 
both 
leads 
will 
be 
reconfirmed, and lead 
positions 
will 
be 
documented using x-ray 
before the Subject leaves 
the procedure room.  The 
day after the procedure, 
Subjects will undergo a 12 lead ECG while pacing with each lead. 
Both leads will undergo daily Electrical Performance Evaluations and in multiple postures when clinically 
appropriate.  Post-operative evaluations will be performed during periods of rest and during activity.  Appropriate 
pacing performance during activity will be evaluated using ECG Holter monitor recordings.  Subjects will also be 
asked patient-centric questions about their experience with the StealthTrac Lead throughout the study period. 
Evaluations will continue until the Subject is discharged from the hospital, with a minimum of two (2) and a 
maximum of seven (7) evaluation days after the index procedure.  Prior to StealthTrac Lead removal, an X-Ray will 
be taken to document the final lead position and diagnostic echocardiography will be performed to (1) detect any 
latent pericardial effusions and (2) assess differences in cardiac function with intrinsic conduction and while pacing 
with the StealthTrac Lead and market released lead.  A final follow-up will be performed 25-30 days after removal 
to identify any latent adverse events before the Subject exits the study. 
 
Figure 1. Study Flow Chart