Subcostal Temporary Extracardiac Pacing II Study

Summary

Up to 12 subjects will be enrolled (up to 8 undergoing an AtaCor Temporary Pacing System procedure) in order to evaluate initial safety and performance of the AtaCor Temporary Pacing System when used with three (3) strategies for stabilizing AtaCor Temporary Pacing System electrical measurements over a two (2) to seven (7) day period. The three treatments are (1) Negative Pressure Wound Therapy, (2) Anti-Inflammatory Glucocorticoid and (3) increased electrode spacing. A control arm with no additional treatment is also included. 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. Appropriate sensing and pacing capture will be ascertained from ECG Holter Monitor recordings during periods of in-hospital ambulation.

Conditions

• Conduction Defect

Interventions

DEVICE

StealthTrac Temporary Pacing Lead Plus Negative Pressure Wound Therapy

Following fixation of the StealthTrac Lead, Negative Pressure Wound Therapy is applied over the incision site.

DEVICE

StealthTrac Temporary Pacing Lead Plus Anti-Inflammatory Glucocorticoid

• Methylprednisolone 125 mg administered over 30 minutes beginning at least 30 minutes prior to the incision and StealthTrac Lead insertion procedure. This intravenous dose can be repeated every 8 hours on day one of the insertion from 1-3 doses depending on the patient's ability to take oral medications. It can be administered daily thereafter until the patient is able to take oral dosing. In normal circumstances, post op day 2, commence oral glucocorticoid (see below for recommended oral dosing). Oral (PO) glucocorticoid preparations and dosing: * Prednisone 40-60 mg orally daily based on BMI category. BMI categories: Low (\<18); Medium (18-30); High (\>30). Low and medium are assigned 40 mg daily. High BMI is assigned 60 mg daily dose. This while the StealthTrac lead remains in place. * Methylprednisolone 16-32 mg daily based on BMI (low, medium and high) while the StealthTrac Lead remains in place.

DEVICE

Two StealthTrac Temporary Pacing Leads (Increased Electrode Spacing)

Once the first StealthTrac Lead is placed using the procedure described in the AtaCor Temporary Pacing System Instructions for Use (DOC-10085), load a second StealthTrac Lead into the same MACH I Delivery Tool, unless it was damaged during insertion of the first StealthTrac Lead, in which case a new MACH I Delivery Tool should be used. Insert the second StealthTrac Lead through (1) a different intercostal muscle path within the same intercostal space or (2) within an adjacent intercostal space. Increased electrode spacing is achieved by pacing between the leads.

DEVICE

StealthTrac Lead Only (Control)

A single StealthTrac Lead is placed with no additional treatment.

Sponsors & Collaborators

• AtaCor Medical, Inc.

  lead INDUSTRY

Principal Investigators

• Martin Burke, D.O. · AtaCor Medical

• Adrian Ebner, M.D. · Sanatorio Italiano

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-28

Primary Completion

2020-12-15

Completion

2021-05-14

Countries

• New Zealand
• Paraguay

Study Locations