Sensing and Defibrillation With a Commercially Available ICD Coupled With a Parasternal Extravascular Lead (SECURE EV) Study

Ventricular Tachycardia Clinical Trial

— SECURE EV  

Official title:

Sensing and Defibrillation With a Commercially Available ICD Coupled With a Parasternal Extravascular Lead (SECURE EV) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05352776
• Other study ID #: DOC-10181
• Status: Completed
• Phase: N/A
• Start date: May 18, 2022
• Est. completion date: October 20, 2022

Study information

• Verified date: August 2023
• Source: AtaCor Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 20, 2022
• Est. primary completion date: September 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Arrhythmia
• Ventricular Fibrillation
• Ventricular Tachycardia

Intervention

Device:
• AtaCor EV-ICD Lead
Subjects will receive the AtaCor EV-ICD Lead being evaluated in the study.

Locations

Country	Name	City	State
Paraguay	Sanatorio Italiano	Asunción

Sponsors (1)

Lead Sponsor	Collaborator
AtaCor Medical, Inc.

Country where clinical trial is conducted

Paraguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of ADEs	Incidence of Adverse Device Effects (ADEs)	Up to 120 days post-implant
Primary	Induced VF Conversion Success	Induced VF conversion success with =10 J safety margin 60-90 days post-implant	Up to 90 days post-implant
Secondary	Lowest Defibrillation Conversion Energy	Lowest Defibrillation Conversion Energy (J) at implant with left mid-axillary PG location	Procedure
Secondary	Induced VF Conversion Success - Implant	Induced VF conversion success rate at implant with left pectoral PG location	Procedure
Secondary	Induced VF Conversion Success - 30 Days	Induced VF conversion success with =10 J safety margin at 30 days	Up to 30 days post-implant
Secondary	Sensing and Detection of Ventricular Arrhythmias	Ability to automatically sense and detect induced and spontaneous ventricular arrhythmias	Up to 90 days post-implant
Secondary	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	Up to 90 days post-implant
Secondary	Detection Time and Time-to-Therapy	EV-ICD VF detection time and time-to-therapy	Up to 90 days post-implant
Secondary	Brady Pacing Electrical Performance: Pacing Capture Threshold	Pacing Capture Threshold (V)	Up to 90 days post-implant
Secondary	Brady Pacing Electrical Performance: Pacing Impedance	Pacing Impedance (ohms)	Up to 90 days post-implant
Secondary	Brady Pacing Electrical Performance: R-wave Amplitude	R-wave Amplitude (mV)	Up to 90 days post-implant