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

NCT06592001 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-12-04

No results posted yet for this study

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

Interventions

DEVICE

Atala™ lead

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

Sponsors & Collaborators

  • AtaCor Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-25
Primary Completion
2025-10-27
Completion
2028-12-31

Countries

  • Croatia
  • New Zealand
  • Paraguay

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06592001 on ClinicalTrials.gov