An interventional study of AtaCor EV-ICD Lead in Ventricular Arrhythmia, 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 2023-08-29.
Sponsored by AtaCor Medical, Inc. · Not applicable, Interventional, and Device feasibility
The SECURE EV Study is a prospective, multi-center, single-arm study without concurrent or historical controls. The objectives of the study are 1) to characterize safety of the AtaCor EV-ICD Lead up to 90 days post-implant, and 2) to characterize sensing and conversion of induced VF up to 90 days post-implant.
The primary safety objective of the study is to characterize safety of the AtaCor EV-ICD Lead up to 90 days post-implant. The primary performance objective is to characterize sensing and conversion of induced VF up to 90 days post-implant.
Up to 3 Investigational Sites Worldwide will participate with up to 20 subjects enrolled in the study. Patients undergoing de novo or replacement ICD procedure will be eligible for participation. Study participation requires sub-chronic evaluation of the lead up to 90 days.
Subjects will receive a concomitant EV-ICD System, comprising the investigational EV-ICD Lead connected to a commercially available ICD. Prior to discharge, the EV-ICD will be programmed to monitor only to detect and store ventricular arrhythmias over the 90-day follow-up period.
After the EV-ICD System is removed (up to 90 days post-implant), the Subject will be followed for an additional 30 days then exit the study. The duration of study participation for an individual Subject is 120 ± 7 days. The study is expected to complete within 6 months of the first enrollment.
451 studies on the registry are indexed under Tachycardia, Ventricular; 120 are open to participants now.
This study's enrollment of 18 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 to give an 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.
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.
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.
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.
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.
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.
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 Model AC-7001
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 120 days post-implant
Induced VF Conversion Success
Induced VF conversion success with ≥10 J safety margin 60-90 days post-implant
Time frame: Up to 90 days post-implant
Lowest Defibrillation Conversion Energy
Lowest Defibrillation Conversion Energy (J) at implant with left mid-axillary PG location
Time frame: Procedure
Induced VF Conversion Success - Implant
Induced VF conversion success rate at implant with left pectoral PG location
Time frame: Procedure
Induced VF Conversion Success - 30 Days
Induced VF conversion success with ≥10 J safety margin at 30 days
Time frame: Up to 30 days post-implant
Sensing and Detection of Ventricular Arrhythmias
Ability to automatically sense and detect induced and spontaneous ventricular arrhythmias
Time frame: Up to 90 days post-implant
Detection Time for VT/VF
Detection time for spontaneous VT/VF episodes recorded during follow-up by the permanent TV-ICD System and concomitantly implanted investigational EV-ICD System
Time frame: Up to 90 days post-implant
Detection Time and Time-to-Therapy
EV-ICD VF detection time and time-to-therapy
Time frame: Up to 90 days post-implant
Brady Pacing Electrical Performance: Pacing Capture Threshold
Pacing Capture Threshold (V)
Time frame: Up to 90 days post-implant
Brady Pacing Electrical Performance: Pacing Impedance
Pacing Impedance (ohms)
Time frame: Up to 90 days post-implant
Brady Pacing Electrical Performance: R-wave Amplitude
R-wave Amplitude (mV)
Time frame: Up to 90 days post-implant
Plan to share: No
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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AtaCor Medical, Inc.