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Sensing and Defibrillation With a Commercially Available ICD Coupled With a Parasternal Extravascular Lead (SECURE EV) Study

NCT05352776 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-08-29

No results posted yet for this study

Summary

The SECURE EV Study is a prospective, multi-center, single-arm study without concurrent or historical controls. The objectives of the study are 1) to characterize safety of the AtaCor EV-ICD Lead up to 90 days post-implant, and 2) to characterize sensing and conversion of induced VF up to 90 days post-implant.

Conditions

  • Ventricular Arrhythmia
  • Ventricular Tachycardia
  • Ventricular Fibrillation

Interventions

DEVICE

AtaCor EV-ICD Lead

Subjects will receive the AtaCor EV-ICD Lead being evaluated in the study.

Sponsors & Collaborators

  • AtaCor Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Martin C Burke, DO · AtaCor Medical, Inc.

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-18
Primary Completion
2022-09-21
Completion
2022-10-20

Countries

  • 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 NCT05352776 on ClinicalTrials.gov