Sensing and Defibrillation With a Commercially Available ICD Coupled With a Parasternal Extravascular Lead (SECURE EV) Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AtaCor EV-ICD Lead System 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.
|
Outcome Measures
Primary Outcome Measures
- Incidence of ADEs [Up to 120 days post-implant]
Incidence of Adverse Device Effects (ADEs)
- Induced VF Conversion Success [Up to 90 days post-implant]
Induced VF conversion success with ≥10 J safety margin 60-90 days post-implant
Secondary Outcome Measures
- Lowest Defibrillation Conversion Energy [Procedure]
Lowest Defibrillation Conversion Energy (J) at implant with left mid-axillary PG location
- Induced VF Conversion Success - Implant [Procedure]
Induced VF conversion success rate at implant with left pectoral PG location
- Induced VF Conversion Success - 30 Days [Up to 30 days post-implant]
Induced VF conversion success with ≥10 J safety margin at 30 days
- Sensing and Detection of Ventricular Arrhythmias [Up to 90 days post-implant]
Ability to automatically sense and detect induced and spontaneous ventricular arrhythmias
- Detection Time for VT/VF [Up to 90 days post-implant]
Detection time for spontaneous VT/VF episodes recorded during follow-up by the permanent TV-ICD System and concomitantly implanted investigational EV-ICD System
- Detection Time and Time-to-Therapy [Up to 90 days post-implant]
EV-ICD VF detection time and time-to-therapy
- Brady Pacing Electrical Performance: Pacing Capture Threshold [Up to 90 days post-implant]
Pacing Capture Threshold (V)
- Brady Pacing Electrical Performance: Pacing Impedance [Up to 90 days post-implant]
Pacing Impedance (ohms)
- Brady Pacing Electrical Performance: R-wave Amplitude [Up to 90 days post-implant]
R-wave Amplitude (mV)
Eligibility Criteria
Criteria
Inclusion Criteria:
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At least 18 years old
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Indicated for de novo or replacement ICD procedure
Exclusion Criteria:
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NYHA IV functional class
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BMI ≥ 35 kg/m2
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Inotropic therapy in past 180 days
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Subjects who require continual ventricular pacing
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Presence or planned use of a subcutaneous ICD lead, subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads within the study period.
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Planned MRI within the study period
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Subjects on anticoagulation or antiplatelet therapy that cannot be temporarily discontinued for the procedure
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Logistical or safety related circumstances that may prevent data collection or follow-up
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Participation in any concurrent clinical study without prior written approval from the Sponsor
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Inability to give an informed consent to participate in the Study
Known prior history for any of the following:
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Structural abnormalities of the heart that may increase risk of the study procedure or an obstructed/restricted pathway into the mediastinum for the EV-ICD Dilator, EV-ICD Delivery Tool and EV-ICD Lead
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Uncontrolled paroxysmal, persistent or permanent atrial fibrillation
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Median or partial sternotomy
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Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium
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Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
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Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments/conditions which may complicate the EV-ICD Lead insertion procedure
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Pericardial disease, pericarditis and mediastinitis
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Medical treatments, surgeries or conditions that increase the potential for pericardial adhesions
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FEV1 < 1.0 Liter
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Surgically corrected congenital heart disease (not including catheter-based procedures)
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Allergies to the device materials as listed in the Instructions for Use (IFU)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanatorio Italiano | Asunción | Paraguay |
Sponsors and Collaborators
- AtaCor Medical, Inc.
Investigators
- Principal Investigator: Martin C Burke, DO, AtaCor Medical, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DOC-10181