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Parasternal Access for ShockS and Pacing With an acUtely Placed Less-invasive Lead for EV-ICD (PASS PULL EV-ICD) Study (PASS PULL)

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
AtaCor Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ventricular Arrhythmia focused on measuring Ventricular Defibrillation

Eligibility Criteria

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

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 with a hemodynamically unstable intrinsic heart rate that requires continual ventricular pacing
  5. Presence or planned use of subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads
  6. Subjects on anticoagulation/antiplatelet therapy that cannot be temporarily discontinued for the procedure
  7. Logistical or safety related circumstances that may prevent data collection or follow-up
  8. Participation in any concurrent clinical study without prior written approval from the Sponsor

  9. Inability to give an informed consent to participate in the Study

    Known prior history for any of the following:

  10. 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 as assessed from available CT or Echocardiography.
  11. Uncontrolled paroxysmal, persistent or permanent atrial fibrillation
  12. Median or partial sternotomy
  13. Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium
  14. Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
  15. Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments/conditions which may complicate the EV-ICD Lead insertion procedure
  16. Pericardial disease, pericarditis and mediastinitis
  17. Medical treatments, surgeries or conditions that increase the potential for pericardial adhesions
  18. FEV1 < 1.0 Liter
  19. Surgically corrected congenital heart disease (not including catheter-based procedures)
  20. 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 inserted with the AtaCor EV-ICD Lead Model AC-7000

Outcomes

Primary Outcome Measures

Incidence of SADEs
Incidence of Serious Adverse Device Effects (SADEs)
Rate of Insertion Success
Defined as the ability to deploy the lead in a position within the mediastinum that is suitable for defibrillation testing and does not result in one (1) or more SADEs

Secondary Outcome Measures

Functionality - Lowest Defibrillation Conversion Energy
Lowest Defibrillation Conversion Energy (J)
Observational: Incidence of ADEs
Incidence of Adverse Device Effects (ADEs), Overall and Individual

Full Information

First Posted
September 29, 2021
Last Updated
July 5, 2022
Sponsor
AtaCor Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05099289
Brief Title
Parasternal Access for ShockS and Pacing With an acUtely Placed Less-invasive Lead for EV-ICD (PASS PULL EV-ICD) Study
Acronym
PASS PULL
Official Title
Parasternal Access for ShockS and Pacing With an acUtely Placed Less-invasive Lead for EV-ICD (PASS PULL EV-ICD) Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 17, 2021 (Actual)
Primary Completion Date
February 17, 2022 (Actual)
Study Completion Date
March 31, 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 PASS PULL EV-ICD Study is a prospective, multi-center, single-arm study without concurrent or historical controls. This initial concept feasibility study is primarily intended to demonstrate that the EV-ICD Lead can be safely positioned within the anterior mediastinum as intended using the AtaCor delivery system. The study will secondarily characterize the ability for the EV-ICD Lead to facilitate VF sensing and defibrillation.
Detailed Description
The primary objective of the study is to demonstrate that the AtaCor EV-ICD Lead can be safely positioned within the anterior mediastinum as intended using the EV-ICD Dilator and EV-ICD Delivery Tool. The study will secondarily characterize the ability for the EV-ICD Lead to facilitate VF sensing and defibrillation. Up to 3 Investigational Sites will participate with up to 65 subjects enrolled in the study. Patients undergoing de novo or replacement ICD procedure will be eligible for participation. Study participation requires acute evaluation of the EV-ICD Lead during the index procedure. Echocardiography will be used to evaluate any new or worsening pericardial effusions. A follow-up visit will occur 7-10 days post-removal via phone, video call, or in-person. Participation will end after completion of the 7-10 days post-removal visit. The Study is expected to last up to 3 months for 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

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
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AtaCor EV-ICD Lead System
Arm Type
Experimental
Arm Description
Subjects inserted with the AtaCor EV-ICD Lead Model AC-7000
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 SADEs
Description
Incidence of Serious Adverse Device Effects (SADEs)
Time Frame
Up to 10 days post-procedure
Title
Rate of Insertion Success
Description
Defined as the ability to deploy the lead in a position within the mediastinum that is suitable for defibrillation testing and does not result in one (1) or more SADEs
Time Frame
Procedure
Secondary Outcome Measure Information:
Title
Functionality - Lowest Defibrillation Conversion Energy
Description
Lowest Defibrillation Conversion Energy (J)
Time Frame
Procedure
Title
Observational: Incidence of ADEs
Description
Incidence of Adverse Device Effects (ADEs), Overall and Individual
Time Frame
Up to 10 days post-procedure

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 with a hemodynamically unstable intrinsic heart rate that requires continual ventricular pacing Presence or planned use of subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads Subjects on anticoagulation/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 as assessed from available CT or Echocardiography. 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

Learn more about this trial

Parasternal Access for ShockS and Pacing With an acUtely Placed Less-invasive Lead for EV-ICD (PASS PULL EV-ICD) Study

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