Conduction Defect
Conditions
Keywords
Temporary Ventricular Pacing, Extravascular
Brief summary
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.
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. Up to three (3) Investigational Sites will participate with up to 50 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. Study duration estimated to be 3 years after the first study enrollment.
Interventions
DEVICEAtaCor StealthTrac Lead
Subjects will receive the AtaCor StealthTrac Lead being evaluated in the study.
Sponsors
AtaCor Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pacing Capture Threshold (mA or V) | Up to 2 days post-insertion | Summary statistics for pacing capture threshold with the StealthTrac Lead from insertion through removal |
| Impedance (Ohms) | Up to 2 days post-insertion | Summary statistics for impedance with the StealthTrac Lead from insertion through removal |
| Freedom from ADEs | Up to 2 days post-insertion | Freedom from Adverse Device Effects (ADE) |
| Sensed R-Wave Amplitude (mV) | Up to 2 days post-insertion | Summary statistics for sensed R-wave amplitude with the StealthTrac Lead from insertion through removal |
Countries
Paraguay
Outcome results
None listed