Conduction DefectSTEP IVNCT05457673
Subcostal Temporary Extravascular Pacing IV (STEP IV) 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 IV Study is a prospective, single-center, non-randomized, single-arm study without concurrent or historical controls. The objective of the study is to generate safety and performance data of the latest AtaCor EV Temporary Pacing Lead System to support the development of a future pivotal study with an… 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
- 12 participants
- Where
- 1 siteParaguay
- Study dates
- 17 Aug 2022to 20 Oct 2022
- 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
- Indicated for closed-chest cardiac invasive procedure (e.g., transcatheter valve replacement, balloon valvuloplasty, permanent pacemaker implantation and pacing lead extractions/revisions)
Who cannot join
- BMI ≥ 35 kg/m2
- Septic shock
- Severe anemia
- Acute coronary syndrome within past 90 days
- NYHA IV Functional Classification of heart failure within past 90 days
- Circumstances that prevent data collection or follow-up (e.g., inability to perform a short walk with the Holter monitor)
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- Participation in any concurrent clinical study without prior written approval from the Sponsor
- Inability or unwillingness to provide informed consent to participate in the Study
- Known prior history for any of the following:
- Median or partial sternotomy
- Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium
- Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
- Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments/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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The STEP IV Study is a prospective, single-center, non-randomized, single-arm study without concurrent or historical controls. The objective of the study is to generate safety and performance data of the latest AtaCor EV Temporary Pacing Lead System to support the development of a future pivotal study with an indication limited to a maximum of 7 days.
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.
One (1) Investigational Site in Paraguay will participate with up to 16 subjects enrolled in the study. Subjects indicated for a closed-chest cardiac invasive procedure will be eligible for participation. Subjects undergoing a qualifying index procedure will have a Model AC-1013 StealthTrac Lead inserted and evaluated over the follow-up period (up to 7 days post procedure). Study participation requires 2 to 7 days with the Study Lead inserted. Following Study Lead removal, a final follow-up will be performed 27-33 days after lead insertion to assess for any latent Adverse Events. Subjects remain enrolled until completion of the 30-Day Follow Up.
The maximum duration for study participation is 33 days. The Study is expected to last up to 3 months after first enrollment: Enrollment and follow-up (1 month) and final report (2 months).
- 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-1013 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 (ADEs)
Measured: Up to 7 days post-implant
Pacing Capture Threshold (V or mA)
Summary statistics for pacing capture threshold with the StealthTrac Lead from insertion through removal
Measured: Up to 7 days post-implant
Impedance (Ohms)
Summary statistics for impedance with the StealthTrac Lead from insertion through removal
Measured: Up to 7 days post-implant
Sensed R-Wave Amplitude (mV)
Summary statistics for sensed R-wave amplitude with the StealthTrac Lead from insertion through removal
Measured: Up to 7 days post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start17 Aug 2022
- Primary completion22 Sep 2022
- Study completion20 Oct 2022
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
- 12 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
- NCT05457673
- Sponsor's protocol ID
- DOC-10200
- Acronym
- STEP IV
- Status last verified
- Mar 2023
- First submitted
- 6 Jul 2022
- Last updated
- 3 Mar 2023
- 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 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcostal Temporary Extravascular Pacing IV (STEP IV) Study
- ClinicalTrials.gov ID
- NCT05457673
- Acronym / sponsor ID
- STEP IV / DOC-10200
- Conditions
- Conduction Defect
- Keywords
- Temporary Ventricular Pacing, Extravascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AtaCor Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 14 Jul 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 IV Study is a prospective, single-center, non-randomized, single-arm study without concurrent or historical controls. The objective of the study is to generate safety and performance data of the latest AtaCor EV Temporary Pacing Lead System to support the development of a future pivotal study with an indication limited to a maximum of 7 days.
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.
One (1) Investigational Site in Paraguay will participate with up to 16 subjects enrolled in the study. Subjects indicated for a closed-chest cardiac invasive procedure will be eligible for participation. Subjects undergoing a qualifying index procedure will have a Model AC-1013 StealthTrac Lead inserted and evaluated over the follow-up period (up to 7 days post procedure). Study participation requires 2 to 7 days with the Study Lead inserted. Following Study Lead removal, a final follow-up will be performed 27-33 days after lead insertion to assess for any latent Adverse Events. Subjects remain enrolled until completion of the 30-Day Follow Up.
The maximum duration for study participation is 33 days. The Study is expected to last up to 3 months after first enrollment: Enrollment and follow-up (1 month) and final report (2 months).
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-1013 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 18 years old
- Indicated for closed-chest cardiac invasive procedure (e.g., transcatheter valve replacement, balloon valvuloplasty, permanent pacemaker implantation and pacing lead extractions/revisions)
Key exclusion criteria (18 listed)
- BMI ≥ 35 kg/m2
- Septic shock
- Severe anemia
- Acute coronary syndrome within past 90 days
- NYHA IV Functional Classification of heart failure within past 90 days
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 7 days post-implant
Freedom from Adverse Device Effects (ADEs)
Pacing Capture Threshold (V or mA)
Time frame: Up to 7 days post-implant
Summary statistics for pacing capture threshold with the StealthTrac Lead from insertion through removal
Impedance (Ohms)
Time frame: Up to 7 days post-implant
Summary statistics for impedance with the StealthTrac Lead from insertion through removal
Sensed R-Wave Amplitude (mV)
Time frame: Up to 7 days post-implant
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 3 Mar 2023.
- 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 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 2 inclusion and 18 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 3 Mar 2023. 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 7 days post-implant). 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 3 Mar 2023; AzTrials last refreshed its copy on 30 Oct 2026.