Assessment of a Chronically Implanted Parasternally Delivered EV-ICD Lead (ASCEND EV) Study

Not Applicable

Not yet recruiting

• Conditions: Ventricular Arrythmia; Ventricular Fibrillation; Ventricular Tachycardia

• Registration Number: NCT06592001
• Lead Sponsor: AtaCor Medical, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-9-9
• Last Update Posted: 23 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Inclusion Criteria:<br><br> 1. At least 18 years old<br><br> 2. Subjects who meet current indications for ICD therapy<br><br>Exclusion Criteria:<br><br> 1. BMI = 35 kg/m2<br><br> 2. Subjects who require permanent bradycardia pacing or cardiac resynchronization<br> therapy<br><br> 3. Presence or planned use of another active implantable medical device (e.g.,<br> pacemaker, LVAD, neurostimulator, etc...)<br><br> 4. Presence or planned use of a subcutaneous ICD lead, subcutaneous coils/arrays,<br> epicardial patches or epicardial pace/sense leads<br><br> 5. Any known need for future MRI<br><br> 6. Subjects on anticoagulation therapy that cannot be temporarily discontinued for the<br> procedure<br><br> 7. Circumstances that may prevent data collection or follow-up<br><br> 8. Participation in any concurrent clinical study without prior written approval from<br> the Sponsor<br><br> 9. Inability or unwillingness to provide informed consent to participate in the Study<br><br> Known prior history for any of the following:<br><br> 10. NYHA IV functional class in past 90 days<br><br> 11. Inotropic therapy in past 180 days<br><br> 12. Structural abnormalities of the heart that may increase risk of the study procedure<br> or an obstructed/restricted pathway into the mediastinum<br><br> 13. Patients with a medical condition that precludes them from undergoing defibrillation<br> testing:<br><br> - Severe aortic stenosis<br><br> - Current Intracardiac LA or LV thrombus<br><br> - Severe proximal three-vessel or left main coronary artery disease without<br> revascularization<br><br> - Hemodynamic instability<br><br> - Unstable angina<br><br> - Recent stroke or transient ischemic attack (within the last 6 months)<br><br> - Known inadequate external defibrillation<br><br> - LVEF < 20%<br><br> - LVEDD >70 mm Or any other known medical condition not listed that precludes<br> their participation in the opinion of the Investigator.<br><br> 14. Median or partial sternotomy<br><br> 15. Surgery with disruption of the lung, pericardium or connective tissue between the<br> sternum and pericardium<br><br> 16. Significant anatomic derangement of or within the thorax (e.g., pectus excavatum,<br> significant scoliosis)<br><br> 17. Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical<br> treatments/conditions which may complicate the AtaCor EV-ICD Lead System implant<br> procedure<br><br> 18. Any conditions which may complicate the AtaCor EV-ICD Lead System implant procedure<br><br> 19. Pericardial disease, pericarditis and mediastinitis<br><br> 20. Medical treatments, surgeries or conditions that increase the potential for<br> adhesions in the thorax<br><br> 21. FEV1 < 1.0 Liter<br><br> 22. Surgically corrected congenital heart disease (not including catheter-based<br> procedures)<br><br> 23. Allergies to the device materials as listed in the Instructions for Use (IFU)

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from major ADEs;Successful IVA Test