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

The ASCEND EV Study is a prospective, multi-center, single-arm, non-randomized study without concurrent or historical controls. The purpose of the study is to evaluate the Investigational Devices through at least 3-months of follow-up to inform the design of a subsequent pivotal clinical investigation.

The objectives of the study are to: 1) preliminarily validate safety and effectiveness of the Atala™ lead as a permanent ICD lead when used with a compatible ICD pulse generator, 2) evaluate suitability of clinical study testing methods and 3) inform statistically powered primary safety and effectiveness endpoints in a subsequent pivotal clinical investigation.

Study Overview

• Status: Active, not recruiting
• Conditions: Ventricular Fibrillation; Ventricular Tachycardia; Ventricular Arrythmia
• Intervention / Treatment: Device: Atala™ lead

Detailed Description

The primary safety endpoint is freedom from major Adverse Device Effects (ADEs) through 3-months. The primary performance endpoint is successful induced ventricular arrhythmia (IVA) test in the final system configuration.

Up to three (3) Investigational Sites will participate with up to 35 Subjects enrolled in the study. Subjects who meet current indications for ICD therapy will be eligible for participation. Eligible Subjects will receive an Atala™ lead connected to a commercially available ICD positioned in a left pectoral or left lateral location.

The Atala™ lead will be connected to a compatible ICD pulse generator and tested to verify appropriate sensing and defibrillation. Abbreviated IVA testing will be performed at the 3-month follow-up visit to verify continued sensing and defibrillation effectiveness. Starting at 6 months, Subjects will be followed every 6 months until the study is closed. The study is expected to remain open for at least 3 years.

Endpoints will be analyzed and summarized in a final study report after all active Subjects have completed the 3-month visit.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Croatia
  • Split, Croatia, 21000
    • University Hospital Center Split
• New Zealand
  • Christchurch, New Zealand
    • Christchurch Hospital
• Paraguay
  • Asunción, Paraguay
    • Sanatorio Italiano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AtaCor EV-ICD Lead System; Subjects implanted with the Atala™ lead	Device: Atala™ lead; Subjects will receive the Atala™ lead being evaluated in the study.; Other Names: AtaCor EV-ICD Atala™ lead; AtaCor Atala™ lead

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from major ADEs	Freedom from major Adverse Device Effects (ADEs)	Through 3 months post-implant
Successful IVA Test	Successful induced ventricular arrhythmia (IVA) test in the final system configuration	At the time of procedure

Collaborators and Investigators

• Sponsor: AtaCor Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2025
• Primary Completion (Actual): October 27, 2025
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: September 9, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Extravascular; Ventricular Defibrillation
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Tachycardia; Pathological Conditions, Signs and Symptoms; Tachycardia, Ventricular; Ventricular Fibrillation
• Other Study ID Numbers: DOC-10280

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes