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Sub Chronic Evaluation for ATP With an Extravascular Placed ICD Lead (STEP ICD) Study

Primary Purpose

Ventricular Arrythmia, Ventricular Tachycardia, Ventricular Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
Paraguay
Study Type
Interventional
Intervention
AtaCor EV-ICD Lead
Sponsored by
AtaCor Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ventricular Arrythmia focused on measuring Ventricular Defibrillation, Extravascular

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: At least 18 years old Indicated for de novo or replacement ICD procedure Exclusion Criteria: BMI ≥ 35 kg/m2 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 Circumstances that may prevent data collection or follow-up Participation in any concurrent clinical study without prior written approval from the Sponsor Inability or unwillingness to provide informed consent to participate in the Study Known prior history for any of the following: NYHA IV functional class in past 90 days Inotropic therapy in past 180 days Structural abnormalities of the heart that may increase risk of the study procedure or an obstructed/restricted pathway into the mediastinum 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 which may complicate the AtaCor EV-ICD Lead System implant procedure Any conditions which may complicate the AtaCor EV-ICD Lead System implant procedure Pericardial disease, pericarditis and mediastinitis Medical treatments, surgeries or conditions that increase the potential for adhesions in the thorax 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 ItalianoRecruiting

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

Outcomes

Primary Outcome Measures

Incidence of ADEs
Incidence of Adverse Device Effects (ADEs)
Induced VF Conversion Success
Induced VF conversion success up to 3 months post-implant

Secondary Outcome Measures

Full Information

First Posted
March 17, 2023
Last Updated
September 7, 2023
Sponsor
AtaCor Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05791032
Brief Title
Sub Chronic Evaluation for ATP With an Extravascular Placed ICD Lead (STEP ICD) Study
Official Title
Sub Chronic Evaluation for ATP With an Extravascular Placed ICD Lead (STEP ICD) Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

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
STEP ICD is a premarket, exploratory, early feasibility, interventional study designed to evaluate the preliminary safety and performance of the Investigational Devices. The study is intended to inform the final device design which will be further evaluated in traditional feasibility and /or pivotal clinical investigations. The primary safety objective is to characterize safety of the EV-ICD Lead through 3 months post-implant. The primary performance objective is to characterize sensing and conversion of induced VF with the EV-ICD Lead up to 3 months post-implant.
Detailed Description
The primary safety endpoint is incidence of Adverse Device Effects (ADEs). The primary performance endpoint is induced VF conversion success up to 3 months post-implant. Secondary endpoints include defibrillation metrics (i.e., lowest Conversion Energy (J), ability to automatically sense and detect ventricular arrhythmias, detection time and time-to-therapy) and pacing metrics (ventricular capture threshold (V), pacing impedance (ohms), R-wave amplitude (mV), and extracardiac pacing sensation level). Up to 30 eligible Subjects undergoing a pectoral transvenous ICD procedure (de novo or replacement) will receive an EV-ICD Lead connected to a commercially available ICD in a left mid-axillary or left pectoral pocket. The EV-ICD System will be tested in the intended implant location to determine the lowest defibrillation energy. Subjects will remain in the hospital overnight (at a minimum), prior to discharge. Except during testing, the EV-ICD System will remain programmed to monitor only (therapy OFF) to detect and store ventricular arrhythmias over the follow-up period. A concomitantly implanted transvenous ICD (TV-ICD) system will provide any necessary ICD therapy. Non-therapy EV-ICD programming parameters will match the TV-ICD to the extent possible to facilitate recording of matched stored electrograms. Follow-up visits are planned at pre-discharge, 2 weeks, 1 month, 2 months, and 3 months. VF conversion testing will occur prior to lead removal in order to test subchronic defibrillation effectiveness with a submaximal energy shock in standard and/or reverse polarity. At the Lead Removal Follow Up, the EV-ICD System will be explanted and the TV-ICD System left in place. A final follow-up will occur one month after EV-ICD Lead explant to assess any post-explant adverse events prior to study exit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Arrythmia, Ventricular Tachycardia, Ventricular Fibrillation
Keywords
Ventricular Defibrillation, Extravascular

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

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
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 3 months post-implant
Title
Induced VF Conversion Success
Description
Induced VF conversion success up to 3 months post-implant
Time Frame
Up to 3 months 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: BMI ≥ 35 kg/m2 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 Circumstances that may prevent data collection or follow-up Participation in any concurrent clinical study without prior written approval from the Sponsor Inability or unwillingness to provide informed consent to participate in the Study Known prior history for any of the following: NYHA IV functional class in past 90 days Inotropic therapy in past 180 days Structural abnormalities of the heart that may increase risk of the study procedure or an obstructed/restricted pathway into the mediastinum 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 which may complicate the AtaCor EV-ICD Lead System implant procedure Any conditions which may complicate the AtaCor EV-ICD Lead System implant procedure Pericardial disease, pericarditis and mediastinitis Medical treatments, surgeries or conditions that increase the potential for adhesions in the thorax 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Husby, MS, MPH
Phone
+1 949-392-8988
Email
michael@atacor.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Hase, BS, CCRA
Phone
+1 612-716-0654
Email
sarah@atacor.com
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Santiago Gallo, MD
Phone
021202767
Email
santigallo56@yahoo.com
First Name & Middle Initial & Last Name & Degree
Adrian Ebner, MD

12. IPD Sharing Statement

Learn more about this trial

Sub Chronic Evaluation for ATP With an Extravascular Placed ICD Lead (STEP ICD) Study

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