NCT04374929|Completed
Subcostal Temporary Extracardiac Pacing II Study
STEP II
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STEP II
Sponsor study identifier
interventional
7
2 countries
2
Study Start
July 28, 2020
Actual (reported)Primary Completion
December 15, 2020
Actual (reported)Study Completion
May 14, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 14, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 1, 2020
Actual (reported)May 5, 2020
Actual (reported)July 28, 2020
Actual (reported)December 15, 2020
Actual (reported)May 14, 2021
Actual (reported)Safety Outcome: Number of Subjects Experiencing an Adverse Device Effect
Number of Subjects Experiencing an Adverse Device Effect
30 days
Performance Outcome
Mean Pacing Capture Threshold (V)
Up to 7 days post insertion
Performance Outcome
Mean Pacing Impedance (Ohms)
Up to 7 days post insertion
Performance Outcome
Mean R-Wave Amplitude (mV)
Up to 7 days post insertion
Following fixation of the StealthTrac Lead, Negative Pressure Wound Therapy is applied over the incision site.
• 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.
Christchurch Hospital
Christchurch, New Zealand
Sanatorio Italiano
Asunción, Paraguay
Martin Burke, D.O.
AtaCor Medical
Adrian Ebner, M.D.
Sanatorio Italiano
7 participants (actual enrollment reported by the registry).
First Submitted
May 1, 2020
First Posted
May 5, 2020
Study Start
July 28, 2020
Actual (reported)Pilot evaluatIon Of NovEl tEmpoRary ExtraVascular PACING (PIONEER EV PACING) Study
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.
A single StealthTrac Lead is placed with no additional treatment.
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Primary Completion
December 15, 2020
Actual (reported)Study Completion
May 14, 2021
Actual (reported)Last Updated
June 11, 2021
Record last verified: 2021-06
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Source: ClinicalTrials.gov.
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