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

NCT ID: NCT05352776

Last Updated: 2023-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-18
• Study Completion Date: 2022-10-20

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.

Conditions

Ventricular Arrhythmia; Ventricular Tachycardia; Ventricular Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

AtaCor EV-ICD Lead System

Subjects implanted with the AtaCor EV-ICD Lead Model AC-7001

Group Type: EXPERIMENTAL

AtaCor EV-ICD Lead

Intervention Type: DEVICE

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

Interventions

AtaCor EV-ICD Lead

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

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AtaCor Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin C Burke, DO

Role: PRINCIPAL_INVESTIGATOR

AtaCor Medical, Inc.

Locations

Sanatorio Italiano

Asunción, , Paraguay

Countries

Paraguay

Other Identifiers

DOC-10181

Identifier Type: -

Identifier Source: org_study_id