Ventricular Arrhythmia, Ventricular Fibrillation, Ventricular Tachycardia
Conditions
Keywords
Ventricular Defibrillation
Brief summary
The PASS PULL EV-ICD Study is a prospective, multi-center, single-arm study without concurrent or historical controls. This initial concept feasibility study is primarily intended to demonstrate that the EV-ICD Lead can be safely positioned within the anterior mediastinum as intended using the AtaCor delivery system. The study will secondarily characterize the ability for the EV-ICD Lead to facilitate VF sensing and defibrillation.
Detailed description
The primary objective of the study is to demonstrate that the AtaCor EV-ICD Lead can be safely positioned within the anterior mediastinum as intended using the EV-ICD Dilator and EV-ICD Delivery Tool. The study will secondarily characterize the ability for the EV-ICD Lead to facilitate VF sensing and defibrillation. Up to 3 Investigational Sites will participate with up to 65 subjects enrolled in the study. Patients undergoing de novo or replacement ICD procedure will be eligible for participation. Study participation requires acute evaluation of the EV-ICD Lead during the index procedure. Echocardiography will be used to evaluate any new or worsening pericardial effusions. A follow-up visit will occur 7-10 days post-removal via phone, video call, or in-person. Participation will end after completion of the 7-10 days post-removal visit. The Study is expected to last up to 3 months for 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
BASIC_SCIENCE
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 with a hemodynamically unstable intrinsic heart rate that requires continual ventricular pacing 5. Presence or planned use of subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads 6. Subjects on anticoagulation/antiplatelet therapy that cannot be temporarily discontinued for the procedure 7. Logistical or safety related circumstances that may prevent data collection or follow-up 8. Participation in any concurrent clinical study without prior written approval from the Sponsor 9. Inability to give an informed consent to participate in the Study Known prior history for any of the following: 10. 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 as assessed from available CT or Echocardiography. 11. Uncontrolled paroxysmal, persistent or permanent atrial fibrillation 12. Median or partial sternotomy 13. Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium 14. Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis) 15. Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments/conditions which may complicate the EV-ICD Lead insertion procedure 16. Pericardial disease, pericarditis and mediastinitis 17. Medical treatments, surgeries or conditions that increase the potential for pericardial adhesions 18. FEV1 \< 1.0 Liter 19. Surgically corrected congenital heart disease (not including catheter-based procedures) 20. Allergies to the device materials as listed in the Instructions for Use (IFU)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of SADEs | Up to 10 days post-procedure | Incidence of Serious Adverse Device Effects (SADEs) |
| Rate of Insertion Success | Procedure | Defined as the ability to deploy the lead in a position within the mediastinum that is suitable for defibrillation testing and does not result in one (1) or more SADEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functionality - Lowest Defibrillation Conversion Energy | Procedure | Lowest Defibrillation Conversion Energy (J) |
| Observational: Incidence of ADEs | Up to 10 days post-procedure | Incidence of Adverse Device Effects (ADEs), Overall and Individual |
Countries
Paraguay
Outcome results
None listed