Subcostal Temporary Extravascular Pacing IV (STEP IV) Study

Study Overview
=================
Brief Summary
-----------------
The STEP IV Study is a prospective, single-center, non-randomized, single-arm study without concurrent or historical controls. The objective of the study is to generate safety and performance data of the latest AtaCor EV Temporary Pacing Lead System to support the development of a future pivotal study with an indication limited to a maximum of 7 days.

Detailed Description
-----------------
The primary safety objective is freedom from Adverse Device Effects (ADE). The primary performance objective is summary statistics for pacing capture threshold, impedance, and sensed R-wave amplitude with the StealthTrac Lead from insertion through removal. One (1) Investigational Site in Paraguay will participate with up to 16 subjects enrolled in the study. Subjects indicated for a closed-chest cardiac invasive procedure will be eligible for participation. Subjects undergoing a qualifying index procedure will have a Model AC-1013 StealthTrac Lead inserted and evaluated over the follow-up period (up to 7 days post procedure). Study participation requires 2 to 7 days with the Study Lead inserted. Following Study Lead removal, a final follow-up will be performed 27-33 days after lead insertion to assess for any latent Adverse Events. Subjects remain enrolled until completion of the 30-Day Follow Up. The maximum duration for study participation is 33 days. The Study is expected to last up to 3 months after first enrollment: Enrollment and follow-up (1 month) and final report (2 months).

Official Title
-----------------
Subcostal Temporary Extravascular Pacing IV (STEP IV) Study

Conditions
-----------------
Conduction Defect

Intervention / Treatment
-----------------
* Device: AtaCor StealthTrac Lead


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years old Indicated for closed-chest cardiac invasive procedure (e.g., transcatheter valve replacement, balloon valvuloplasty, permanent pacemaker implantation and pacing lead extractions/revisions) Exclusion Criteria: BMI ≥ 35 kg/m2 Septic shock Severe anemia Acute coronary syndrome within past 90 days NYHA IV Functional Classification of heart failure within past 90 days Circumstances that prevent data collection or follow-up (e.g., inability to perform a short walk with the Holter monitor) Participation in any concurrent clinical study without prior written approval from the Sponsor Inability or unwillingness to provide informed consent to participate in the Study Known prior history for any of the following: Median or partial sternotomy Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis) Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments/conditions which may complicate the AtaCor EV Temporary Pacing Lead System insertion procedure Pericardial disease, pericarditis and mediastinitis Medical treatments, surgeries or conditions that increase the potential for pericardial adhesions FEV1 < 1 liter Surgically corrected congenital heart disease (not including catheter-based procedures) Allergies to the device materials such as stainless steel, titanium, platinum, iridium, polyethylene, polyurethane, polycarbonate, and silicone

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AtaCor EV Temporary Pacing Lead System<br>Subjects implanted with the AtaCor StealthTrac Lead Model AC-1013 | Device: AtaCor StealthTrac Lead<br>* Subjects will receive the AtaCor StealthTrac Lead being evaluated in the study.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from ADEs | Freedom from Adverse Device Effects (ADEs) | Up to 7 days post-implant | 
| Pacing Capture Threshold (V or mA) | Summary statistics for pacing capture threshold with the StealthTrac Lead from insertion through removal | Up to 7 days post-implant | 
| Impedance (Ohms) | Summary statistics for impedance with the StealthTrac Lead from insertion through removal | Up to 7 days post-implant | 
| Sensed R-Wave Amplitude (mV) | Summary statistics for sensed R-wave amplitude with the StealthTrac Lead from insertion through removal | Up to 7 days post-implant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Temporary Ventricular Pacing, Extravascular