An interventional study of AtaCor StealthTrac Lead in Conduction Defect, sponsored by AtaCor Medical, Inc.. Completed at 1 site in Paraguay. 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 Basic science
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.
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.
1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.
This study's enrollment of 29 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 indicated for closed-chest cardiac invasive procedure, including:
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 ADEs
Freedom from Adverse Device Effects (ADE)
Time frame: 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
Time frame: Up to 2 days post-insertion
Impedance (Ohms)
Summary statistics for impedance with the StealthTrac Lead from insertion through removal
Time frame: 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
Time frame: Up to 2 days post-insertion
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.