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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04374929




Registration number
NCT04374929
Ethics application status
Date submitted
1/05/2020
Date registered
5/05/2020
Date last updated
11/06/2021

Titles & IDs
Public title
Subcostal Temporary Extracardiac Pacing II Study
Scientific title
Subcostal Temporary Extracardiac Pacing II (STEP II) Study
Secondary ID [1] 0 0
DOC-10084
Universal Trial Number (UTN)
Trial acronym
STEP II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Conduction Defect 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - StealthTrac Temporary Pacing Lead Plus Negative Pressure Wound Therapy
Treatment: Devices - StealthTrac Temporary Pacing Lead Plus Anti-Inflammatory Glucocorticoid
Treatment: Devices - Two StealthTrac Temporary Pacing Leads (Increased Electrode Spacing)
Treatment: Devices - StealthTrac Lead Only (Control)

Active Comparator: Negative Pressure Wound Therapy -

Active Comparator: Anti-Inflammatory Glucocorticoid -

Active Comparator: Increased Electrode Spacing -

Other: Control -


Treatment: Devices: 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.

Treatment: Devices: 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.

Treatment: Devices: 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.

Treatment: Devices: StealthTrac Lead Only (Control)
A single StealthTrac Lead is placed with no additional treatment.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety Outcome: Number of Subjects Experiencing an Adverse Device Effect
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Performance Outcome
Timepoint [2] 0 0
Up to 7 days post insertion
Primary outcome [3] 0 0
Performance Outcome
Timepoint [3] 0 0
Up to 7 days post insertion
Primary outcome [4] 0 0
Performance Outcome
Timepoint [4] 0 0
Up to 7 days post insertion

Eligibility
Key inclusion criteria
1. Indicated for closed-chest cardiac invasive procedure that does not require full
systemic anticoagulation during the procedure.

Examples of such procedures include: transcatheter valve replacement, balloon
valvuloplasty, implantable cardioverter-defibrillator (ICD) implantation, permanent
pacemaker implantation and pacing lead extractions/revisions.

2. Physically and mentally capable of providing informed consent and at least 18 years of
age or of legal age to provide consent as required by local and national requirements.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of a prior sternotomy (median or partial);

2. History of prior surgery with disruption of the lung, pericardium or connective tissue
between the sternum and pericardium;

3. History of significant anatomic derangement of or within the thorax (e.g., pectus
excavatum, significant scoliosis), prior chest radiation therapy or other reasons
which may cause pericardial adhesions or complicate the AtaCor Temporary Pacing System
insertion procedure;

4. History of pericardial disease, pericarditis or mediastinitis;

5. History of chronic obstructive pulmonary disease (COPD);

6. NYHA functional classification IV at the time of enrollment;

7. History of congenital heart disease;

8. Patients with circumstances that prevent data collection or follow-up;

9. BMI > 35 kg/m2;

10. Contraindication to glucocorticoid medication;

11. History of allergies to any study devices; and

12. Participation in any concurrent study without prior, written approval from the
Sponsor.

Study design
Purpose of the study
Basic Science
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/05/2021
Sample size
Target
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch
Country [2] 0 0
Paraguay
State/province [2] 0 0
Asunción

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AtaCor Medical, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04374929
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Martin Burke, D.O.
Address 0 0
AtaCor Medical
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries