Ventricular Arrhythmia, Ventricular Fibrillation, Ventricular Tachycardia
Conditions
Keywords
Ventricular Defibrillation, Extravascular
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.
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.
Interventions
DEVICEAtaCor EV-ICD Lead
Subjects will receive the AtaCor EV-ICD Lead being evaluated in the study.
Sponsors
AtaCor Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least 18 years old 2. Indicated for de novo or replacement ICD procedure
Exclusion criteria
1. NYHA IV functional class 2. BMI ≥ 35 kg/m2 3. Inotropic therapy in past 180 days 4. Subjects who require continual ventricular pacing 5. Presence or planned use of a subcutaneous ICD lead, subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads within the study period. 6. Planned MRI within the study period 7. Subjects on anticoagulation or antiplatelet therapy that cannot be temporarily discontinued for the procedure 8. Logistical or safety related circumstances that may prevent data collection or follow-up 9. Participation in any concurrent clinical study without prior written approval from the Sponsor 10. Inability to give an informed consent to participate in the Study Known prior history for any of the following: 11. 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 12. Uncontrolled paroxysmal, persistent or permanent atrial fibrillation 13. Median or partial sternotomy 14. Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium 15. Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis) 16. Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments/conditions which may complicate the EV-ICD Lead insertion procedure 17. Pericardial disease, pericarditis and mediastinitis 18. Medical treatments, surgeries or conditions that increase the potential for pericardial adhesions 19. FEV1 \< 1.0 Liter 20. Surgically corrected congenital heart disease (not including catheter-based procedures) 21. Allergies to the device materials as listed in the Instructions for Use (IFU)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Lowest Defibrillation Conversion Energy | Procedure | Lowest Defibrillation Conversion Energy (J) at implant with left mid-axillary PG location |
| 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) |
| Detection Time and Time-to-Therapy | Up to 90 days post-implant | EV-ICD VF detection time and time-to-therapy |
| Induced VF Conversion Success - Implant | Procedure | Induced VF conversion success rate at implant with left pectoral PG location |
Countries
Paraguay
Outcome results
None listed