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:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT05791032
Eligibility Criteria:
Inclusion Criteria:
1. At least 18 years old
2. Indicated for de novo or replacement ICD procedure
Exclusion Criteria:
1. BMI ≥ 35 kg/m2
2. Subjects who require continual ventricular pacing
3. Presence or planned use of a subcutaneous ICD lead, subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads within the study period
4. Planned MRI within the study period
5. Subjects on anticoagulation or antiplatelet therapy that cannot be temporarily discontinued for the procedure
6. Circumstances that may prevent data collection or follow-up
7. Participation in any concurrent clinical study without prior written approval from the Sponsor
8. Inability or unwillingness to provide informed consent to participate in the Study
Known prior history for any of the following:
9. NYHA IV functional class in past 90 days
10. Inotropic therapy in past 180 days
11. Structural abnormalities of the heart that may increase risk of the study procedure or an obstructed/restricted pathway into the mediastinum
12. Uncontrolled paroxysmal, persistent or permanent atrial fibrillation
13. Median or partial sternotomy
14. Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium
15. Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
16. Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments which may complicate the AtaCor EV-ICD Lead System implant procedure
17. Any conditions which may complicate the AtaCor EV-ICD Lead System implant procedure
18. Pericardial disease, pericarditis and mediastinitis
19. Medical treatments, surgeries or conditions that increase the potential for adhesions in the thorax
20. FEV1 \< 1.0 Liter
21. Surgically corrected congenital heart disease (not including catheter-based procedures)
22. Allergies to the device materials as listed in the Instructions for Use (IFU)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05791032
Study Brief:
Protocol Section:
NCT05791032