An interventional study of AtaCor EV-ICD Lead in Ventricular Arrythmia, Ventricular Tachycardia and Ventricular Fibrillation, sponsored by AtaCor Medical, Inc.. Completed at 1 site in Paraguay. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-03.
Sponsored by AtaCor Medical, Inc. · Not applicable, Interventional, and Basic science
STEP ICD is a premarket, exploratory, early feasibility, interventional study designed to evaluate the preliminary safety and performance of the Investigational Devices. The study is intended to inform the final device design which will be further evaluated in traditional feasibility and /or pivotal clinical investigations.
The primary safety objective is to characterize safety of the EV-ICD Lead through 3 months post-implant. The primary performance objective is to characterize sensing and conversion of induced VF with the EV-ICD Lead up to 3 months post-implant.
The primary safety endpoint is incidence of Adverse Device Effects (ADEs). The primary performance endpoint is induced VF conversion success up to 3 months post-implant. Secondary endpoints include defibrillation metrics (i.e., lowest Conversion Energy (J), ability to automatically sense and detect ventricular arrhythmias, detection time and time-to-therapy) and pacing metrics (ventricular capture threshold (V), pacing impedance (ohms), R-wave amplitude (mV), and extracardiac pacing sensation level).
Up to 30 eligible Subjects undergoing a pectoral transvenous ICD procedure (de novo or replacement) will receive an EV-ICD Lead connected to a commercially available ICD in a left mid-axillary or left pectoral pocket.
The EV-ICD System will be tested in the intended implant location to determine the lowest defibrillation energy. Subjects will remain in the hospital overnight (at a minimum), prior to discharge. Except during testing, the EV-ICD System will remain programmed to monitor only (therapy OFF) to detect and store ventricular arrhythmias over the follow-up period. A concomitantly implanted transvenous ICD (TV-ICD) system will provide any necessary ICD therapy. Non-therapy EV-ICD programming parameters will match the TV-ICD to the extent possible to facilitate recording of matched stored electrograms.
Follow-up visits are planned at pre-discharge, 2 weeks, 1 month, 2 months, and 3 months. VF conversion testing will occur prior to lead removal in order to test subchronic defibrillation effectiveness with a submaximal energy shock in standard and/or reverse polarity. At the Lead Removal Follow Up, the EV-ICD System will be explanted and the TV-ICD System left in place.
A final follow-up will occur one month after EV-ICD Lead explant to assess any post-explant adverse events prior to study exit.
451 studies on the registry are indexed under Tachycardia, Ventricular; 120 are open to participants now.
This study's enrollment of 21 is below the median of 71 across 280 interventional studies indexed under Tachycardia, Ventricular.
Browse Tachycardia, Ventricular studies →AtaCor Medical, Inc. is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
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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.
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 EV-ICD Lead
Device: AtaCor EV-ICD Lead
Subjects will receive the AtaCor EV-ICD Lead being evaluated in the study.
Incidence of ADEs
Incidence of Adverse Device Effects (ADEs)
Time frame: Up to 3 months post-implant
Induced VF Conversion Success
Induced VF conversion success up to 3 months post-implant
Time frame: Up to 3 months post-implant
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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AtaCor Medical, Inc.