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Parasternal Access for ShockS and Pacing With an acUtely Placed Less-invasive Lead for EV-ICD (PASS PULL EV-ICD) Study

NCT05099289 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-07-08

No results posted yet for this study

Summary

The PASS PULL EV-ICD Study is a prospective, multi-center, single-arm study without concurrent or historical controls. This initial concept feasibility study is primarily intended to demonstrate that the EV-ICD Lead can be safely positioned within the anterior mediastinum as intended using the AtaCor delivery system. The study will secondarily characterize the ability for the EV-ICD Lead to facilitate VF sensing and defibrillation.

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
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-17
Primary Completion
2022-02-17
Completion
2022-03-31

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 NCT05099289 on ClinicalTrials.gov