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Sub Chronic Evaluation for ATP With an Extravascular Placed ICD Lead (STEP ICD) Study

NCT05791032 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-04-03

No results posted yet for this study

Summary

STEP ICD is a premarket, exploratory, early feasibility, interventional study designed to evaluate the preliminary safety and performance of the Investigational Devices. The study is intended to inform the final device design which will be further evaluated in traditional feasibility and /or pivotal clinical investigations.

The primary safety objective is to characterize safety of the EV-ICD Lead through 3 months post-implant. The primary performance objective is to characterize sensing and conversion of induced VF with the EV-ICD Lead up to 3 months post-implant.

Conditions

  • Ventricular Arrythmia
  • 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
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-05
Primary Completion
2024-02-22
Completion
2024-03-19

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 NCT05791032 on ClinicalTrials.gov