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

Launched by ATACOR MEDICAL, INC. · Sep 9, 2024

Keywords

ClinConnect Summary

The ASCEND EV Study is a clinical trial aimed at evaluating a new lead, called the Atala™ lead, which is used in a device known as an Implantable Cardioverter Defibrillator (ICD). This device helps patients who have serious heart rhythm problems, such as ventricular tachycardia and ventricular fibrillation. The main goal of the study is to assess the safety and effectiveness of this lead over a period of at least three months. Participants will help researchers learn how to improve future studies that may involve larger groups of people.

To be eligible for this study, you need to be at least 18 years old and meet certain heart health guidelines that suggest you may benefit from an ICD. However, there are some restrictions, such as not being able to participate if you have certain medical conditions or if you've had specific surgeries that could complicate the procedure. If you choose to participate, you will be monitored closely for three months to ensure your safety and to gather important data about the device. This study is currently recruiting participants of all genders between the ages of 18 and older.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. At least 18 years old
• • 2. Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines or ESC guidelines
• Exclusion Criteria:
• • 1. Participation in any concurrent clinical study without prior written approval from the Sponsor
• • 2. Inability or unwillingness to provide informed consent to participate in the Study
• • 3. Any known conditions which may complicate the AtaCor EV-ICD Lead System implant procedure or prevent the subject from completing protocol testing through the 3-month follow-up visit
• • 4. Circumstances that may prevent data collection or completion of specified follow-up visits
• • 5. Allergies to any device materials listed in the Instructions for Use (IFU)
• • 6. Subjects on anticoagulation therapy that cannot be temporarily discontinued for the procedure
• • 7. Known history of lung disease with FEV1 \< 1.0 Liter
• Device Related:
• • 8. Presence or planned use of medical devices that introduce current into the body (e.g., pacemaker, LVAD, neurostimulator, etc.)
• • 9. Implanted with or planned implantation of any device which delivers current in the body, that may interfere with therapy delivery, including, but not limited to a pacemaker, or neurostimulator
• • 10. Presence or planned use of a subcutaneous ICD lead, subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads
• • 11. Any known need for future MRI
• Anatomy Related:
• • 12. BMI ≥ 35 kg/m2
• • 13. Structural abnormalities of the heart that may increase risk of the study procedure or an obstructed/restricted pathway into the mediastinum
• • 14. Prior sternotomy of any type, including but not limited to median, mini or clamshell
• • 15. Prior surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium
• • 16. Known significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis) and associated with displacement of the heart or lungs or impeded mediastinal access.
• • 17. History of thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments/conditions which may complicate the AtaCor EV-ICD Lead System implant procedure
• • 18. Known adhesions in the thorax or history of medical treatments, surgeries or conditions that increase the potential for adhesions in the thorax
• • 19. Surgically corrected congenital heart disease (not including catheter-based procedures)
• Cardiac Related:
• • 20. Subjects who require permanent bradycardia pacing or cardiac resynchronization therapy
• • 21. NYHA IV functional class in past 90 days
• • 22. Inotropic therapy in past 180 days
• • 23. Known history of pericardial disease, pericarditis or mediastinitis
• 24. Patients with a medical condition that precludes them from undergoing defibrillation testing:
• • Severe aortic stenosis
• • Current Intracardiac LA or LV thrombus
• • Severe proximal three-vessel or left main coronary artery disease without revascularization
• • Hemodynamic instability
• • Unstable angina
• • Recent stroke or transient ischemic attack (within the last 6 months)
• • Known inadequate external defibrillation
• • LVEF \< 20%
• • LVEDD \>70 mm