Conduction DefectSTEP IINCT04374929
Subcostal Temporary Extracardiac Pacing II Study
A study testing StealthTrac Temporary Pacing Lead Plus Negative Pressure Wound Therapy, StealthTrac Temporary Pacing Lead Plus Anti-Inflammatory Glucocorticoid and Two StealthTrac Temporary Pacing Leads (Increased Electrode Spacing) in people with Conduction Defect, run by AtaCor Medical, Inc. at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conduction Defect
- What is being tested?
- StealthTrac Temporary Pacing Lead Plus Negative Pressure Wound Therapy, StealthTrac Temporary Pacing Lead Plus Anti-Inflammatory Glucocorticoid and Two StealthTrac Temporary Pacing Leads (Increased Electrode Spacing)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 Jul 2020to 14 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Subcostal Temporary Extracardiac Pacing II (STEP II) Study
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.
Read the detailed description
Enrolled Subjects will have both a market-released transvenous pacing lead and investigational StealthTrac Temporary Pacing Lead placed and evaluated. Following StealthTrac Lead insertion, each subject will receive (1) one of three (3) study treatments intended to stabilize pacing capture thresholds and pacing impedance over time or receive no treatment. The three treatments are (1) Negative Pressure Wound Therapy, (2) Anti-Inflammatory Glucocorticoid and (3) increased electrode spacing achieved by the use of two inserted StealthTrac Leads. During the placement procedure, diagnostic echocardiograms will be performed to detect any new pericardial effusions. Once inserted, the StealthTrac Lead will be used to deliver high rate pacing (160 to 220 BPM) in clinically appropriate Subjects, to demonstrate suitability for use in transcatheter procedures that require brief periods of temporary pacing. Lead positions will be documented using fluoroscopic images before the Subject leaves the procedure room. On the following two days after the procedure, electrical performance will be evaluated in multiple postures and appropriate pacing and sensing will be confirmed during activity using ECG Holter monitor recordings. Subjects will also be asked patient-centric questions about their experience with the StealthTrac Lead throughout the study period. Evaluations will continue for a maximum of seven (7) days after the index procedure. Prior to StealthTrac Lead removal, an X-Ray will be taken to document the final lead position. A final follow-up will be performed 25-30 days after removal to identify any latent adverse events before the Subject exits the study.
- Conditions
- Conduction Defect
- Being tested
- StealthTrac Temporary Pacing Lead Plus Negative Pressure Wound Therapy, StealthTrac Temporary Pacing Lead Plus Anti-Inflammatory Glucocorticoid, Two StealthTrac Temporary Pacing Leads (Increased Electrode Spacing), StealthTrac Lead Only (Control)
- Keywords
- Temporary, Ventricular, Pacing
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StealthTrac Temporary Pacing Lead Plus Negative Pressure Wound TherapyDevice
Following fixation of the StealthTrac Lead, Negative Pressure Wound Therapy is applied over the incision site.
StealthTrac Temporary Pacing Lead Plus Anti-Inflammatory GlucocorticoidDevice
- 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.
Two StealthTrac Temporary Pacing Leads (Increased Electrode Spacing)Device
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.
StealthTrac Lead Only (Control)Device
A single StealthTrac Lead is placed with no additional treatment.
| Study group | Role | What they receive |
|---|---|---|
| Negative Pressure Wound Therapy | Active comparator | Not described Receives: Device: StealthTrac Temporary Pacing Lead Plus Negative Pressure Wound Therapy |
| Anti-Inflammatory Glucocorticoid | Active comparator | Not described Receives: Device: StealthTrac Temporary Pacing Lead Plus Anti-Inflammatory Glucocorticoid |
| Increased Electrode Spacing | Active comparator | Not described Receives: Device: Two StealthTrac Temporary Pacing Leads (Increased Electrode Spacing) |
| Control | Other | Not described Receives: Device: StealthTrac Lead Only (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Outcome: Number of Subjects Experiencing an Adverse Device Effect
Number of Subjects Experiencing an Adverse Device Effect
Measured: 30 days
Performance Outcome
Mean Pacing Capture Threshold (V)
Measured: Up to 7 days post insertion
Performance Outcome
Mean Pacing Impedance (Ohms)
Measured: Up to 7 days post insertion
Performance Outcome
Mean R-Wave Amplitude (mV)
Measured: Up to 7 days post insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start28 Jul 2020
- Primary completion15 Dec 2020
- Study completion14 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conduction DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- AtaCor Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Burke, D.O., Principal investigator, AtaCor MedicalAdrian Ebner, M.D., Principal investigator, Sanatorio Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374929
- Sponsor's protocol ID
- DOC-10084
- Acronym
- STEP II
- Status last verified
- Jun 2021
- First submitted
- 1 May 2020
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcostal Temporary Extracardiac Pacing II (STEP II) Study
- ClinicalTrials.gov ID
- NCT04374929
- Acronym / sponsor ID
- STEP II / DOC-10084
- Conditions
- Conduction Defect
- Keywords
- Temporary, Ventricular, Pacing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- AtaCor Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 14 May 2021 (actual)
- First posted
- 5 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Enrolled Subjects will have both a market-released transvenous pacing lead and investigational StealthTrac Temporary Pacing Lead placed and evaluated. Following StealthTrac Lead insertion, each subject will receive (1) one of three (3) study treatments intended to stabilize pacing capture thresholds and pacing impedance over time or receive no treatment. The three treatments are (1) Negative Pressure Wound Therapy, (2) Anti-Inflammatory Glucocorticoid and (3) increased electrode spacing achieved by the use of two inserted StealthTrac Leads. During the placement procedure, diagnostic echocardiograms will be performed to detect any new pericardial effusions. Once inserted, the StealthTrac Lead will be used to deliver high rate pacing (160 to 220 BPM) in clinically appropriate Subjects, to demonstrate suitability for use in transcatheter procedures that require brief periods of temporary pacing. Lead positions will be documented using fluoroscopic images before the Subject leaves the procedure room. On the following two days after the procedure, electrical performance will be evaluated in multiple postures and appropriate pacing and sensing will be confirmed during activity using ECG Holter monitor recordings. Subjects will also be asked patient-centric questions about their experience with the StealthTrac Lead throughout the study period. Evaluations will continue for a maximum of seven (7) days after the index procedure. Prior to StealthTrac Lead removal, an X-Ray will be taken to document the final lead position. A final follow-up will be performed 25-30 days after removal to identify any latent adverse events before the Subject exits the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure Wound Therapy | Active comparator | Device: StealthTrac Temporary Pacing Lead Plus Negative Pressure Wound Therapy |
| Anti-Inflammatory Glucocorticoid | Active comparator | Device: StealthTrac Temporary Pacing Lead Plus Anti-Inflammatory Glucocorticoid |
| Increased Electrode Spacing | Active comparator | Device: Two StealthTrac Temporary Pacing Leads (Increased Electrode Spacing) |
| Control | Other | Device: StealthTrac Lead Only (Control) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StealthTrac Temporary Pacing Lead Plus Negative Pressure Wound TherapyFollowing fixation of the StealthTrac Lead, Negative Pressure Wound Therapy is applied over the incision site. | Device | Negative Pressure Wound Therapy |
| 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 | Anti-Inflammatory Glucocorticoid |
| 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 | Increased Electrode Spacing |
| StealthTrac Lead Only (Control)A single StealthTrac Lead is placed with no additional treatment. | Device | Control |
Primary outcome
Safety Outcome: Number of Subjects Experiencing an Adverse Device Effect
Time frame: 30 days
Number of Subjects Experiencing an Adverse Device Effect
Performance Outcome
Time frame: Up to 7 days post insertion
Mean Pacing Capture Threshold (V)
Performance Outcome
Time frame: Up to 7 days post insertion
Mean Pacing Impedance (Ohms)
Performance Outcome
Time frame: Up to 7 days post insertion
Mean R-Wave Amplitude (mV)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Burke, D.O. principal investigator
AtaCor Medical
Adrian Ebner, M.D. principal investigator
Sanatorio Italiano
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StealthTrac Temporary Pacing Lead Plus Negative Pressure Wound Therapy, StealthTrac Temporary Pacing Lead Plus Anti-Inflammatory Glucocorticoid and Two StealthTrac Temporary Pacing Leads (Increased Electrode Spacing) in people with Conduction Defect, run by AtaCor Medical, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in New Zealand, Paraguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Outcome: Number of Subjects Experiencing an Adverse Device Effect (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.