- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04374929
Subcostal Temporary Extracardiac Pacing II Study (STEP II)
Subcostal Temporary Extracardiac Pacing II (STEP II) Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Christchurch, New Zealand
- Christchurch Hospital
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-
-
-
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Asunción, Paraguay
- Sanatorio Italiano
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
- 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.
Exclusion Criteria:
- History of a prior sternotomy (median or partial);
- History of prior surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium;
- 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;
- History of pericardial disease, pericarditis or mediastinitis;
- History of chronic obstructive pulmonary disease (COPD);
- NYHA functional classification IV at the time of enrollment;
- History of congenital heart disease;
- Patients with circumstances that prevent data collection or follow-up;
- BMI > 35 kg/m2;
- Contraindication to glucocorticoid medication;
- History of allergies to any study devices; and
- Participation in any concurrent study without prior, written approval from the Sponsor.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Control
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A single StealthTrac Lead is placed with no additional treatment.
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ACTIVE_COMPARATOR: Negative Pressure Wound Therapy
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Following fixation of the StealthTrac Lead, Negative Pressure Wound Therapy is applied over the incision site.
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ACTIVE_COMPARATOR: Anti-Inflammatory Glucocorticoid
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• 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:
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ACTIVE_COMPARATOR: Increased Electrode Spacing
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety Outcome: Number of Subjects Experiencing an Adverse Device Effect
Time Frame: 30 days
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Number of Subjects Experiencing an Adverse Device Effect
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30 days
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Performance Outcome
Time Frame: Up to 7 days post insertion
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Mean Pacing Capture Threshold (V)
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Up to 7 days post insertion
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Performance Outcome
Time Frame: Up to 7 days post insertion
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Mean Pacing Impedance (Ohms)
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Up to 7 days post insertion
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Performance Outcome
Time Frame: Up to 7 days post insertion
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Mean R-Wave Amplitude (mV)
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Up to 7 days post insertion
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Martin Burke, D.O., AtaCor Medical
- Principal Investigator: Adrian Ebner, M.D., Sanatorio Italiano
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DOC-10084
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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