Subcostal Temporary Extravascular Pacing V Study

Study Overview
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Brief Summary
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The STEP V Study is a prospective, multicenter, acute (in-hospital), single-arm feasibility study. The objective of the study is to evaluate the early safety and performance of the latest AtaCor EV Temporary Pacing Lead System over a two-day use period with Subjects restricted to bedrest. Lead performance will also be evaluated without bedrest restrictions in the limited period shortly before lead removal on the last follow-up day.

Detailed Description
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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. Up to three (3) Investigational Sites will participate with up to 16 subjects enrolled in the study. Subjects indicated for closed-chest cardiac invasive procedures will be eligible for participation. Subjects undergoing a qualifying index procedure will have a Model AC-101400 StealthTrac Lead inserted and evaluated over the follow-up period. Subject participation is expected to be 2 days with the Study Lead inserted, plus 30 days post lead removal. A 30 day (+/-3 days) post-removal follow-up will also be performed to document 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
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Subcostal Temporary Extravascular Pacing V (STEP V) Study

Conditions
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Conduction Defect

Intervention / Treatment
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* Device: AtaCor StealthTrac Lead


Participation Criteria
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Eligibility Criteria
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Inclusion criteria At least 18 years old Subjects indicated for closed-chest cardiac invasive procedure, including: Transarterial transcatheter aortic valve implantation (TAVI) Transarterial balloon aortic valvuloplasty (BAV) Cardiovascular implantable electronic device (CIED) pulse generator replacement Cardiovascular implantable electronic device (CIED) lead extraction or revision Exclusion criteria BMI ≥ 35 kg/m2 Septic shock Severe anemia Patients on dual antiplatelet therapy or anti-coagulation that cannot be stopped for the procedure 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 Acute coronary syndrome within past 90 days NYHA Functional Classification IV within past 90 days 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 Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium, including adhesions Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis) Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments which may complicate the AtaCor EV Temporary Pacing Lead System insertion procedure Any 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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-101400 | Device: AtaCor StealthTrac Lead<br>* Subjects will receive the AtaCor StealthTrac Lead being evaluated in the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from ADEs | Freedom from Adverse Device Effects (ADE) | Up to 2 days post-insertion | 
| Pacing Capture Threshold (mA or V) | Summary statistics for pacing capture threshold with the StealthTrac Lead from insertion through removal | Up to 2 days post-insertion | 
| Impedance (Ohms) | Summary statistics for impedance with the StealthTrac Lead from insertion through removal | Up to 2 days post-insertion | 
| Sensed R-Wave Amplitude (mV) | Summary statistics for sensed R-wave amplitude with the StealthTrac Lead from insertion through removal | Up to 2 days post-insertion | 

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