Clinical Trial

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

Study acronym: ASCEND EV
Active, Not Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2024-09-09; most recent amendment 2025-12-03.
Status change: Recruiting → Active, Not Recruiting 2025-09-29
Status change: Not Yet Recruiting → Recruiting 2025-03-07
Trial Details
NCT Number NCT06592001
Lead Sponsor AtaCor Medical, Inc.
Conditions Ventricular Arrythmia, Ventricular Fibrillation, Ventricular Tachycardia
Enrollment 19 participants
Start Date 2025-02-25
Primary Completion 2025-10-27 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-04