MedTrace Logo

Subcostal Temporary Extracardiac Pacing Study

NCT04096365 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-02-03

Study results available
· View outcomes & findings →

Summary

Up to 15 subjects will be enrolled to evaluate initial safety and performance of the AtaCor Temporary Pacing System. Safety will be evaluated through analysis of all Adverse Events. Performance will be evaluated through (1) the incidence of successful StealthTrac Lead placement using the MACH I Delivery Tool, (2) electrical performance measurements, such as pacing capture thresholds, sensed R-wave amplitudes, pacing impedance and skeletal muscle stimulation at rest. Appropriate sensing and pacing capture will be ascertained from ECG Holter Monitor recordings during periods of in-hospital ambulation.

Conditions

  • Conduction Defect

Interventions

DEVICE

Subcostal Temporary Extracardiac Pacing Lead

The StealthTrac Lead is designed to facilitate extracardiac temporary ventricular pacing and sensing. The distal end of the StealthTrac Lead is designed to reside within the connective tissue of the anterior mediastinum outside the pericardium. The StealthTrac Lead is delivered using the MACH I Delivery Tool, which is designed to facilitate insertion of the StealthTrac Lead through a small skin incision parallel to the sternum, without the need for fluoroscopic guidance.

Sponsors & Collaborators

  • AtaCor Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Martin Burke, D.O. · AtaCor Medical

  • Adrian Ebner, M.D. · Sanatorio Italiano

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-25
Primary Completion
2019-11-07
Completion
2019-11-07
FDA Device
Yes

Countries

  • Paraguay

Study Locations

More Related Trials

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 NCT04096365 on ClinicalTrials.gov