Evaluation of a new heart device for treating serious heart rhythm issues

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

This study is testing a new heart device to see if it safely helps people with serious heart rhythm problems.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AtaCor Medical, Inc. (industry)
• Drugs / interventions: radiation
• Locations: 3 sites (Split and 2 other locations)
• Trial ID: NCT06592001 on ClinicalTrials.gov

What this trial studies

The ASCEND EV Study is a prospective, multi-center, single-arm investigation aimed at assessing the safety and effectiveness of the Atala™ lead as a permanent implantable cardioverter-defibrillator (ICD) lead. Participants will receive the Atala™ lead connected to a compatible ICD, and their progress will be monitored for at least three months to evaluate device performance and safety. The study will involve up to 35 subjects across three investigational sites, with follow-up assessments to ensure proper device function and to inform future clinical investigations.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a Class I or IIa indication for ICD implantation according to established guidelines.

Not a fit: Patients with contraindications for the Atala™ lead implant procedure or those unable to comply with follow-up requirements may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective option for patients requiring ICD therapy for life-threatening heart rhythm disorders.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in the past, indicating potential for success.

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

Where this trial is running

Split and 2 other locations

• University Hospital Center Split — Split, Croatia (NOT_YET_RECRUITING)
• Christchurch Hospital — Christchurch, New Zealand (NOT_YET_RECRUITING)
• Sanatorio Italiano — Asunción, Paraguay (RECRUITING)

Study contacts

• Study coordinator: Sarah Hase, BS, CCRA

Conditions: Ventricular Arrythmia, Ventricular Fibrillation, Ventricular Tachycardia, Ventricular Defibrillation, Extravascular