Back to resultsSensing and Defibrillation With a Commercially Available ICD Coupled With a Parasternal Extravascular Lead (SECURE EV) Study (SECURE EV)
Primary Purpose
Ventricular Arrhythmia, Ventricular Tachycardia, Ventricular Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Paraguay
Study Type
Interventional
Intervention
AtaCor EV-ICD Lead
Sponsored by
About this trial
This is an interventional device feasibility trial for Ventricular Arrhythmia focused on measuring Ventricular Defibrillation, Extravascular
Eligibility Criteria
Inclusion Criteria:
- At least 18 years old
- Indicated for de novo or replacement ICD procedure
Exclusion Criteria:
- 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
- Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
- Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments/conditions which may complicate the EV-ICD Lead insertion procedure
- Pericardial disease, pericarditis and mediastinitis
- Medical treatments, surgeries or conditions that increase the potential for pericardial adhesions
- FEV1 < 1.0 Liter
- Surgically corrected congenital heart disease (not including catheter-based procedures)
- Allergies to the device materials as listed in the Instructions for Use (IFU)
Sites / Locations
- Sanatorio Italiano
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AtaCor EV-ICD Lead System
Arm Description
Subjects implanted with the AtaCor EV-ICD Lead Model AC-7001
Outcomes
Primary Outcome Measures
Incidence of ADEs
Incidence of Adverse Device Effects (ADEs)
Induced VF Conversion Success
Induced VF conversion success with ≥10 J safety margin 60-90 days post-implant
Secondary Outcome Measures
Lowest Defibrillation Conversion Energy
Lowest Defibrillation Conversion Energy (J) at implant with left mid-axillary PG location
Induced VF Conversion Success - Implant
Induced VF conversion success rate at implant with left pectoral PG location
Induced VF Conversion Success - 30 Days
Induced VF conversion success with ≥10 J safety margin at 30 days
Sensing and Detection of Ventricular Arrhythmias
Ability to automatically sense and detect induced and spontaneous ventricular arrhythmias
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
Detection Time and Time-to-Therapy
EV-ICD VF detection time and time-to-therapy
Brady Pacing Electrical Performance: Pacing Capture Threshold
Pacing Capture Threshold (V)
Brady Pacing Electrical Performance: Pacing Impedance
Pacing Impedance (ohms)
Brady Pacing Electrical Performance: R-wave Amplitude
R-wave Amplitude (mV)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05352776
Brief Title
Sensing and Defibrillation With a Commercially Available ICD Coupled With a Parasternal Extravascular Lead (SECURE EV) Study
Acronym
SECURE EV
Official Title
Sensing and Defibrillation With a Commercially Available ICD Coupled With a Parasternal Extravascular Lead (SECURE EV) Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 18, 2022 (Actual)
Primary Completion Date
September 21, 2022 (Actual)
Study Completion Date
October 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AtaCor Medical, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Arrhythmia, Ventricular Tachycardia, Ventricular Fibrillation
Keywords
Ventricular Defibrillation, Extravascular
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AtaCor EV-ICD Lead System
Arm Type
Experimental
Arm Description
Subjects implanted with the AtaCor EV-ICD Lead Model AC-7001
Intervention Type
Device
Intervention Name(s)
AtaCor EV-ICD Lead
Intervention Description
Subjects will receive the AtaCor EV-ICD Lead being evaluated in the study.
Primary Outcome Measure Information:
Title
Incidence of ADEs
Description
Incidence of Adverse Device Effects (ADEs)
Time Frame
Up to 120 days post-implant
Title
Induced VF Conversion Success
Description
Induced VF conversion success with ≥10 J safety margin 60-90 days post-implant
Time Frame
Up to 90 days post-implant
Secondary Outcome Measure Information:
Title
Lowest Defibrillation Conversion Energy
Description
Lowest Defibrillation Conversion Energy (J) at implant with left mid-axillary PG location
Time Frame
Procedure
Title
Induced VF Conversion Success - Implant
Description
Induced VF conversion success rate at implant with left pectoral PG location
Time Frame
Procedure
Title
Induced VF Conversion Success - 30 Days
Description
Induced VF conversion success with ≥10 J safety margin at 30 days
Time Frame
Up to 30 days post-implant
Title
Sensing and Detection of Ventricular Arrhythmias
Description
Ability to automatically sense and detect induced and spontaneous ventricular arrhythmias
Time Frame
Up to 90 days post-implant
Title
Detection Time for VT/VF
Description
Detection time for spontaneous VT/VF episodes recorded during follow-up by the permanent TV-ICD System and concomitantly implanted investigational EV-ICD System
Time Frame
Up to 90 days post-implant
Title
Detection Time and Time-to-Therapy
Description
EV-ICD VF detection time and time-to-therapy
Time Frame
Up to 90 days post-implant
Title
Brady Pacing Electrical Performance: Pacing Capture Threshold
Description
Pacing Capture Threshold (V)
Time Frame
Up to 90 days post-implant
Title
Brady Pacing Electrical Performance: Pacing Impedance
Description
Pacing Impedance (ohms)
Time Frame
Up to 90 days post-implant
Title
Brady Pacing Electrical Performance: R-wave Amplitude
Description
R-wave Amplitude (mV)
Time Frame
Up to 90 days post-implant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 18 years old
Indicated for de novo or replacement ICD procedure
Exclusion Criteria:
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
Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments/conditions which may complicate the EV-ICD Lead insertion procedure
Pericardial disease, pericarditis and mediastinitis
Medical treatments, surgeries or conditions that increase the potential for pericardial adhesions
FEV1 < 1.0 Liter
Surgically corrected congenital heart disease (not including catheter-based procedures)
Allergies to the device materials as listed in the Instructions for Use (IFU)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin C Burke, DO
Organizational Affiliation
AtaCor Medical, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanatorio Italiano
City
Asunción
Country
Paraguay
12. IPD Sharing Statement
Plan to Share IPD
No
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Sensing and Defibrillation With a Commercially Available ICD Coupled With a Parasternal Extravascular Lead (SECURE EV) Study
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