Conduction DefectNCT05610033
Pilot evaluatIon Of NovEl tEmpoRary ExtraVascular PACING (PIONEER EV PACING) Study
A study testing AtaCor StealthTrac Lead in people with Conduction Defect, run by AtaCor Medical, Inc. at 1 site in Croatia.
Trial summary
The PIONEER EV PACING Study is prospective, multi-center, acute (in-hospital), single-arm, pilot study. The study objective is to characterize preliminary safety and performance of the AtaCor EV Temporary Pacing Lead System when used as intended for clinical use as a temporary pacing lead. 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 siteCroatia
- Study dates
- 19 Sep 2023to 12 Jan 2024
- 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 who:
- Are undergoing one of the following planned (non-urgent) procedures that are associated with the potential need for temporary bradycardia pacing:
- 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
- Subjects with bradycardia who are under evaluation to determine if the cause is transient or permanent
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
- Participation in any concurrent clinical study without prior written approval from the Sponsor
Show all 20Show fewer
- 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
The PIONEER EV PACING Study is prospective, multi-center, acute (in-hospital), single-arm, pilot study. The study objective is to characterize preliminary safety and performance of the AtaCor EV Temporary Pacing Lead System when used as intended for clinical use as a temporary pacing lead.
Read the detailed description
The primary safety endpoint is freedom from Adverse Device Effects, CTCAE Grade 3 or higher. The primary performance endpoint is percentage of Subjects with demonstrated pacing capture following lead fixation.
Up to 30 subjects will be enrolled at up to three (3) investigation centers. Enrolled subjects will undergo insertion of a StealthTrac Lead within one calendar day of an eligible planned index procedure that requires a temporary pacing lead. Echocardiographic evaluations will be performed before and after StealthTrac Lead insertion, as well as after the index procedure, to assess for pericardial effusion. Post-operative fluoroscopic images are required in all subjects to document the final lead position. In subjects without an underlying ventricular escape rhythm, a concomitant, commercially available pacing lead is required. Lead measurements (Thresholds, Impedance, R-Waves) and an insertion procedure survey will be obtained.
Subjects will be restricted to bed rest while the StealthTrac lead remains inserted. The StealthTrac Lead will be connected to a commercially available, constant-current temporary pacemaker programmed by the investigator to provide temporary pacing support. The StealthTrac Lead will remain inserted until the next calendar day, at a minimum, and will be removed once the clinical need for temporary pacing ends. The maximum duration of lead insertion is two (2) days following the lead insertion procedure.
Follow up evaluations will be performed for as long as the StealthTrac Lead remains inserted. Subjects will also undergo a 30-day post-removal follow-up before completing participation. On the final follow-up, prior to StealthTrac Lead removal, Subjects may be tested in multiple postures. Subjects with pacing capture in the upright posture may have ECGs recorded during various isometrics or while walking with pacing from the StealthTrac Lead.
Prior to removal, a final lead evaluation will be performed and fluoroscopy will be used to document the final lead position. Echocardiographic imaging will be obtained before and after the removal procedure to characterize any new or worsened pericardial effusions. A final post-removal follow-up will be performed in person or remotely to document any latent adverse events.
The overall study is expected to last four (4) months, comprising two (2) months for enrollment and follow-up and two (2) months to monitor study data and prepare a final report.
- 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 severe ADEs
Freedom from Adverse Device Effects, CTCAE Grade 3 or Higher
Measured: Up to 30 days post-lead removal
Percentage of Subjects with pacing capture
Percentage of Subjects with demonstrated pacing capture following lead fixation
Measured: Up to 2 days post-lead insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start19 Sep 2023
- Primary completion15 Dec 2023
- Study completion12 Jan 2024
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
- Treatment
- 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
- NCT05610033
- Sponsor's protocol ID
- DOC-10219
- Status last verified
- Aug 2025
- First submitted
- 30 Oct 2022
- Last updated
- 24 Aug 2025
- 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 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot evaluatIon Of NovEl tEmpoRary ExtraVascular PACING (PIONEER EV PACING) Study
- ClinicalTrials.gov ID
- NCT05610033
- Acronym / sponsor ID
- DOC-10219
- 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
- 19 Sep 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 8 Nov 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 PIONEER EV PACING Study is prospective, multi-center, acute (in-hospital), single-arm, pilot study. The study objective is to characterize preliminary safety and performance of the AtaCor EV Temporary Pacing Lead System when used as intended for clinical use as a temporary pacing lead.
Detailed description
The primary safety endpoint is freedom from Adverse Device Effects, CTCAE Grade 3 or higher. The primary performance endpoint is percentage of Subjects with demonstrated pacing capture following lead fixation.
Up to 30 subjects will be enrolled at up to three (3) investigation centers. Enrolled subjects will undergo insertion of a StealthTrac Lead within one calendar day of an eligible planned index procedure that requires a temporary pacing lead. Echocardiographic evaluations will be performed before and after StealthTrac Lead insertion, as well as after the index procedure, to assess for pericardial effusion. Post-operative fluoroscopic images are required in all subjects to document the final lead position. In subjects without an underlying ventricular escape rhythm, a concomitant, commercially available pacing lead is required. Lead measurements (Thresholds, Impedance, R-Waves) and an insertion procedure survey will be obtained.
Subjects will be restricted to bed rest while the StealthTrac lead remains inserted. The StealthTrac Lead will be connected to a commercially available, constant-current temporary pacemaker programmed by the investigator to provide temporary pacing support. The StealthTrac Lead will remain inserted until the next calendar day, at a minimum, and will be removed once the clinical need for temporary pacing ends. The maximum duration of lead insertion is two (2) days following the lead insertion procedure.
Follow up evaluations will be performed for as long as the StealthTrac Lead remains inserted. Subjects will also undergo a 30-day post-removal follow-up before completing participation. On the final follow-up, prior to StealthTrac Lead removal, Subjects may be tested in multiple postures. Subjects with pacing capture in the upright posture may have ECGs recorded during various isometrics or while walking with pacing from the StealthTrac Lead.
Prior to removal, a final lead evaluation will be performed and fluoroscopy will be used to document the final lead position. Echocardiographic imaging will be obtained before and after the removal procedure to characterize any new or worsened pericardial effusions. A final post-removal follow-up will be performed in person or remotely to document any latent adverse events.
The overall study is expected to last four (4) months, comprising two (2) months for enrollment and follow-up and two (2) months to monitor study data and prepare a final report.
Study design
- Primary purpose
- Treatment
- 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 (8 listed)
- At least 18 years old
- Subjects who:
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
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 severe ADEs
Time frame: Up to 30 days post-lead removal
Freedom from Adverse Device Effects, CTCAE Grade 3 or Higher
Percentage of Subjects with pacing capture
Time frame: Up to 2 days post-lead insertion
Percentage of Subjects with demonstrated pacing capture following lead fixation
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.
- 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 Croatia.
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 8 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 Croatia. 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 severe ADEs (time frame: Up to 30 days post-lead removal). The study lists 2 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.