Conduction DefectSTEP VNCT05633394
Subcostal Temporary Extravascular Pacing V Study
A study testing AtaCor StealthTrac Lead in people with Conduction Defect, run by AtaCor Medical, Inc. at 1 site in Paraguay.
Trial summary
The STEP V Study is a prospective, multicenter, acute (in-hospital), single-arm feasibility study. The objective of the study is to evaluate the early safety and performance of the latest AtaCor EV Temporary Pacing Lead System over a two-day use period. 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?
- AtaCor StealthTrac Lead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteParaguay
- Study dates
- 23 Jan 2023to 30 Jun 2025
- 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
- At least 18 years old
- Subjects indicated for closed-chest cardiac invasive procedure, including:
- Transarterial transcatheter aortic valve implantation (TAVI)
- Transarterial balloon aortic valvuloplasty (BAV)
- Cardiovascular implantable electronic device (CIED) pulse generator replacement
- Cardiovascular implantable electronic device (CIED) lead extraction or revision
Who cannot join
- BMI ≥ 35 kg/m2
- Septic shock
- Severe anemia
- Patients on dual antiplatelet therapy or anti-coagulation that cannot be stopped for the procedure
- Circumstances that prevent data collection or follow-up (e.g., inability to perform a short walk with the Holter monitor)
- Participation in any concurrent clinical study without prior written approval from the Sponsor
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- Inability or unwillingness to provide informed consent to participate in the Study
- Known prior history for any of the following:
- Median or partial sternotomy
- Acute coronary syndrome within past 90 days
- NYHA Functional Classification IV within past 90 days
- Surgically corrected congenital heart disease (not including catheter-based procedures)
- Allergies to the device materials such as stainless steel, titanium, platinum, iridium, polyethylene, polyurethane, polycarbonate and silicone
- Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium, including adhesions
- Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
- Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments which may complicate the AtaCor EV Temporary Pacing Lead System insertion procedure
- Any conditions which may complicate the AtaCor EV Temporary Pacing Lead System insertion procedure
- Pericardial disease, pericarditis and mediastinitis
- Medical treatments, surgeries or conditions that increase the potential for pericardial adhesions
- FEV1 < 1 liter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subcostal Temporary Extravascular Pacing V (STEP V) Study
The STEP V Study is a prospective, multicenter, acute (in-hospital), single-arm feasibility study. The objective of the study is to evaluate the early safety and performance of the latest AtaCor EV Temporary Pacing Lead System over a two-day use period.
Read the detailed description
The primary safety objective is freedom from Adverse Device Effects (ADE). The primary performance objective is summary statistics for pacing capture threshold, impedance, and sensed R-wave amplitude with the StealthTrac Lead from insertion through removal.
Up to three (3) Investigational Sites will participate with up to 50 subjects enrolled in the study. Subjects indicated for closed-chest cardiac invasive procedures will be eligible for participation. Subjects undergoing a qualifying index procedure will have a Model AC-101400 StealthTrac Lead inserted and evaluated over the follow-up period. Subject participation is expected to be 2 days with the Study Lead inserted, plus 30 days post lead removal. A 30 day (+/-3 days) post-removal follow-up will also be performed to document any latent adverse events. Subjects remain enrolled until completion of the 30-Day Follow Up.
The maximum duration for study participation is 33 days. Study duration estimated to be 3 years after the first study enrollment.
- Conditions
- Conduction Defect
- Being tested
- AtaCor StealthTrac Lead
- Keywords
- Temporary Ventricular Pacing, Extravascular
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtaCor StealthTrac LeadDevice
Subjects will receive the AtaCor StealthTrac Lead being evaluated in the study.
| Study group | Role | What they receive |
|---|---|---|
| AtaCor EV Temporary Pacing Lead System | Experimental | Subjects implanted with the AtaCor StealthTrac Lead Model AC-101400 Receives: Device: AtaCor StealthTrac Lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from ADEs
Freedom from Adverse Device Effects (ADE)
Measured: Up to 2 days post-insertion
Pacing Capture Threshold (mA or V)
Summary statistics for pacing capture threshold with the StealthTrac Lead from insertion through removal
Measured: Up to 2 days post-insertion
Impedance (Ohms)
Summary statistics for impedance with the StealthTrac Lead from insertion through removal
Measured: Up to 2 days post-insertion
Sensed R-Wave Amplitude (mV)
Summary statistics for sensed R-wave amplitude with the StealthTrac Lead from insertion through removal
Measured: Up to 2 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 posted1 Dec 2022
- Study start23 Jan 2023
- Primary completion29 May 2025
- Study completion30 Jun 2025
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- AtaCor Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin C Burke, DO, Principal investigator, AtaCor Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633394
- Sponsor's protocol ID
- DOC-10235
- Acronym
- STEP V
- Status last verified
- Aug 2025
- First submitted
- 22 Nov 2022
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcostal Temporary Extravascular Pacing V (STEP V) Study
- ClinicalTrials.gov ID
- NCT05633394
- Acronym / sponsor ID
- STEP V / DOC-10235
- Conditions
- Conduction Defect
- Keywords
- Temporary Ventricular Pacing, Extravascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- AtaCor Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 1 Dec 2022 (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.
The STEP V Study is a prospective, multicenter, acute (in-hospital), single-arm feasibility study. The objective of the study is to evaluate the early safety and performance of the latest AtaCor EV Temporary Pacing Lead System over a two-day use period.
Detailed description
The primary safety objective is freedom from Adverse Device Effects (ADE). The primary performance objective is summary statistics for pacing capture threshold, impedance, and sensed R-wave amplitude with the StealthTrac Lead from insertion through removal.
Up to three (3) Investigational Sites will participate with up to 50 subjects enrolled in the study. Subjects indicated for closed-chest cardiac invasive procedures will be eligible for participation. Subjects undergoing a qualifying index procedure will have a Model AC-101400 StealthTrac Lead inserted and evaluated over the follow-up period. Subject participation is expected to be 2 days with the Study Lead inserted, plus 30 days post lead removal. A 30 day (+/-3 days) post-removal follow-up will also be performed to document any latent adverse events. Subjects remain enrolled until completion of the 30-Day Follow Up.
The maximum duration for study participation is 33 days. Study duration estimated to be 3 years after the first study enrollment.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AtaCor EV Temporary Pacing Lead System | Experimental | Device: AtaCor StealthTrac LeadSubjects implanted with the AtaCor StealthTrac Lead Model AC-101400 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 18 years old
- Subjects indicated for closed-chest cardiac invasive procedure, including:
Key exclusion criteria (20 listed)
- BMI ≥ 35 kg/m2
- Septic shock
- Severe anemia
- Patients on dual antiplatelet therapy or anti-coagulation that cannot be stopped for the procedure
- Circumstances that prevent data collection or follow-up (e.g., inability to perform a short walk with the Holter monitor)
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 |
|---|---|---|
| AtaCor StealthTrac LeadSubjects will receive the AtaCor StealthTrac Lead being evaluated in the study. | Device | AtaCor EV Temporary Pacing Lead System |
Primary outcome
Freedom from ADEs
Time frame: Up to 2 days post-insertion
Freedom from Adverse Device Effects (ADE)
Pacing Capture Threshold (mA or V)
Time frame: Up to 2 days post-insertion
Summary statistics for pacing capture threshold with the StealthTrac Lead from insertion through removal
Impedance (Ohms)
Time frame: Up to 2 days post-insertion
Summary statistics for impedance with the StealthTrac Lead from insertion through removal
Sensed R-Wave Amplitude (mV)
Time frame: Up to 2 days post-insertion
Summary statistics for sensed R-wave amplitude with the StealthTrac Lead from insertion through removal
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 24 Aug 2025.
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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 C Burke, DO principal investigator
AtaCor Medical, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AtaCor StealthTrac Lead in people with Conduction Defect, run by AtaCor Medical, Inc. at 1 site in Paraguay.
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 6 inclusion and 20 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 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Freedom from ADEs (time frame: Up to 2 days post-insertion). 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 24 Aug 2025.