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

NCT05352776 | Completed

• 1 other identifier: DOC-10181
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Arrhythmia; Ventricular Tachycardia; Ventricular Fibrillation

Keywords

Ventricular Defibrillation; Extravascular

Outcome Measures

Primary Outcomes (2)

• Incidence of ADEs

  Incidence of Adverse Device Effects (ADEs)

  Up to 120 days post-implant

• 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 Outcomes (9)

• Lowest Defibrillation Conversion Energy

  Procedure

• Induced VF Conversion Success - Implant

  Procedure

• Induced VF Conversion Success - 30 Days

  Up to 30 days post-implant

• Sensing and Detection of Ventricular Arrhythmias

  Up to 90 days post-implant

• Detection Time for VT/VF

  Up to 90 days post-implant

Study Arms (1)

AtaCor EV-ICD Lead System

EXPERIMENTAL

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

Device: AtaCor EV-ICD Lead

Interventions

AtaCor EV-ICD Lead DEVICE

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

AtaCor EV-ICD Lead System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old
• Indicated for de novo or replacement ICD procedure

You may not qualify if:

• NYHA IV functional class
• BMI ≥ 35 kg/m2
• Inotropic therapy in past 180 days
• Subjects who require continual ventricular pacing
• Presence or planned use of a subcutaneous ICD lead, subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads within the study period.
• Planned MRI within the study period
• Subjects on anticoagulation or antiplatelet therapy that cannot be temporarily discontinued for the procedure
• Logistical or safety related circumstances that may prevent data collection or follow-up
• Participation in any concurrent clinical study without prior written approval from the Sponsor
• Inability to give an informed consent to participate in the Study
• Known prior history for any of the following:
• 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
• Uncontrolled paroxysmal, persistent or permanent atrial fibrillation
• Median or partial sternotomy
• Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium

Sponsors & Collaborators

• AtaCor Medical, Inc.: lead

Study Sites (1)

Sanatorio Italiano

Asunción, Paraguay

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin C Burke, DO

  AtaCor Medical, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 29, 2022
• Study Start: May 18, 2022
• Primary Completion: September 21, 2022
• Study Completion: October 20, 2022
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)