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

NCT06592001 | Active Not Recruiting DMC

• 1 other identifier: DOC-10280
• Study Type: interventional
• Target: 19
• Locations: 3 countries
• Sites: 3

Brief Summary

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.

Conditions

Ventricular Arrythmia; Ventricular Fibrillation; Ventricular Tachycardia

Keywords

Ventricular Defibrillation; Extravascular

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

AtaCor EV-ICD Lead System

EXPERIMENTAL

Subjects implanted with the Atala™ lead

Device: Atala™ lead

Interventions

Atala™ lead DEVICE

Subjects will receive the Atala™ lead being evaluated in the study.

Also known as: AtaCor EV-ICD Atala™ lead, AtaCor Atala™ lead

AtaCor EV-ICD Lead System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old
• Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines or ESC guidelines

You may not qualify if:

• Participation in any concurrent clinical study without prior written approval from the Sponsor
• Inability or unwillingness to provide informed consent to participate in the Study
• 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
• Circumstances that may prevent data collection or completion of specified follow-up visits
• Allergies to any device materials listed in the Instructions for Use (IFU)
• Subjects on anticoagulation therapy that cannot be temporarily discontinued for the procedure
• Known history of lung disease with FEV1 \< 1.0 Liter
• Device Related:
• Presence or planned use of medical devices that introduce current into the body (e.g., pacemaker, LVAD, neurostimulator, etc.)
• 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
• Presence or planned use of a subcutaneous ICD lead, subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads
• Any known need for future MRI
• Anatomy Related:
• BMI ≥ 35 kg/m2
• Structural abnormalities of the heart that may increase risk of the study procedure or an obstructed/restricted pathway into the mediastinum

Sponsors & Collaborators

• AtaCor Medical, Inc.: lead

Study Sites (3)

University Hospital Center Split

Split, 21000, Croatia

Location

Christchurch Hospital

Christchurch, New Zealand

Location

Sanatorio Italiano

Asunción, Paraguay

Location

MeSH Terms

Conditions

Ventricular Fibrillation; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: February 25, 2025
• Primary Completion: October 27, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

PA (1); NZ (1); CR (1)