Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 1:35 AM
NCT ID:
NCT05633394
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05633394
Study Brief:
Protocol Section:
NCT05633394