Subcostal Temporary Extravascular Pacing V Study

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.

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).

Eligibility Criteria:
Inclusion criteria

1. At least 18 years old
2. 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

1. BMI ≥ 35 kg/m2
2. Septic shock
3. Severe anemia
4. Patients on dual antiplatelet therapy or anti-coagulation that cannot be stopped for the procedure
5. Circumstances that prevent data collection or follow-up (e.g., inability to perform a short walk with the Holter monitor)
6. Participation in any concurrent clinical study without prior written approval from the Sponsor
7. Inability or unwillingness to provide informed consent to participate in the Study

   Known prior history for any of the following:
8. Median or partial sternotomy
9. Acute coronary syndrome within past 90 days
10. NYHA Functional Classification IV within past 90 days
11. Surgically corrected congenital heart disease (not including catheter-based procedures)
12. Allergies to the device materials such as stainless steel, titanium, platinum, iridium, polyethylene, polyurethane, polycarbonate and silicone
13. Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium, including adhesions
14. Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
15. Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments which may complicate the AtaCor EV Temporary Pacing Lead System insertion procedure
16. Any conditions which may complicate the AtaCor EV Temporary Pacing Lead System insertion procedure
17. Pericardial disease, pericarditis and mediastinitis
18. Medical treatments, surgeries or conditions that increase the potential for pericardial adhesions
19. FEV1 \< 1 liter