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

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.

Study Overview

• Status: Completed
• Conditions: Ventricular Fibrillation; Ventricular Tachycardia; Ventricular Arrhythmia
• Intervention / Treatment: Device: AtaCor EV-ICD Lead

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Paraguay
  • Asunción, Paraguay
    • Sanatorio Italiano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AtaCor EV-ICD Lead System; Subjects inserted with the AtaCor EV-ICD Lead Model AC-7000	Device: AtaCor EV-ICD Lead; Subjects will receive the AtaCor EV-ICD Lead being evaluated in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of SADEs	Incidence of Serious Adverse Device Effects (SADEs)	Up to 10 days post-procedure
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	Procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functionality - Lowest Defibrillation Conversion Energy	Lowest Defibrillation Conversion Energy (J)	Procedure
Observational: Incidence of ADEs	Incidence of Adverse Device Effects (ADEs), Overall and Individual	Up to 10 days post-procedure

Collaborators and Investigators

• Sponsor: AtaCor Medical, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 17, 2021
• Primary Completion (ACTUAL): February 17, 2022
• Study Completion (ACTUAL): March 31, 2022

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: October 18, 2021
• First Posted (ACTUAL): October 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2022
• Last Update Submitted That Met QC Criteria: July 5, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Ventricular Defibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Ventricular Fibrillation; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: DOC-10154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No