An interventional study of AtaCor StealthTrac Lead in Conduction Defect, sponsored by AtaCor Medical, Inc.. Completed at 1 site in Croatia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-24.
Sponsored by AtaCor Medical, Inc. · Not applicable, Interventional, and Treatment
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.
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.
1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.
This study's enrollment of 12 is below the median of 100 across 517 interventional studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →AtaCor Medical, Inc. is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects who:
Are undergoing one of the following planned (non-urgent) procedures that are associated with the potential need for temporary bradycardia pacing:
Exclusion criteria
Inability or unwillingness to provide to participate in the Study
Known prior history for any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects implanted with the AtaCor StealthTrac Lead Model AC-101400
Device: AtaCor StealthTrac Lead
Subjects will receive the AtaCor StealthTrac Lead being evaluated in the study.
Freedom from severe ADEs
Freedom from Adverse Device Effects, CTCAE Grade 3 or Higher
Time frame: Up to 30 days post-lead removal
Percentage of Subjects with pacing capture
Percentage of Subjects with demonstrated pacing capture following lead fixation
Time frame: Up to 2 days post-lead insertion
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2023 to primary completion in Dec 2023, 2 months.
Of 71 industry-sponsored interventional studies with no phase under Arrhythmias, Cardiac, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 28. This study's 2 months is below that.
Counting every sponsor, half of 242 studies reached it within 24 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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AtaCor Medical, Inc.