Clinical trial NCT05352776: Sensing and Defibrillation With a Commercially Available ICD Coupled With a Parasternal Extravascular Lead (SECURE EV) Study
Official title: Sensing and Defibrillation With a Commercially Available ICD Coupled With a Parasternal Extravascular Lead (SECURE EV) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Arrhythmia
Ventricular Tachycardia
Ventricular Fibrillation
Keywords: Ventricular Defibrillation
Extravascular
Lead sponsor: AtaCor Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-29
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Incidence of ADEs
timeFrame: Up to 120 days post-implant
measure: Induced VF Conversion Success
timeFrame: Up to 90 days post-implant
Secondary outcomes:
measure: Lowest Defibrillation Conversion Energy
timeFrame: Procedure
measure: Induced VF Conversion Success - Implant
timeFrame: Procedure
measure: Induced VF Conversion Success - 30 Days
timeFrame: Up to 30 days post-implant
measure: Sensing and Detection of Ventricular Arrhythmias
timeFrame: Up to 90 days post-implant
measure: Detection Time for VT/VF
timeFrame: Up to 90 days post-implant
measure: Detection Time and Time-to-Therapy
timeFrame: Up to 90 days post-implant
measure: Brady Pacing Electrical Performance: Pacing Capture Threshold
timeFrame: Up to 90 days post-implant
measure: Brady Pacing Electrical Performance: Pacing Impedance
timeFrame: Up to 90 days post-implant
measure: Brady Pacing Electrical Performance: R-wave Amplitude
timeFrame: Up to 90 days post-implant
Other outcomes:
Locations:
city: Asunción
country: Paraguay
facility: Sanatorio Italiano
Study officials:
affiliation: AtaCor Medical, Inc.
name: Martin C Burke, DO
role: PRINCIPAL_INVESTIGATOR
References: