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

• Sponsor: AtaCor Medical, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05099289
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arm: 1
• Actual Duration (Months): 4.4
• Patients Per Site Per Month: 4.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ventricular Arrhythmia; Ventricular Tachycardia; Ventricular Fibrillation	Device: AtaCor EV-ICD Lead	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Parasternal Access for ShockS and Pacing With an acUtely Placed Less-invasive Lead for EV-ICD (PASS PULL EV-ICD) Study
• Actual Study Start Date: Nov 17, 2021
• Actual Primary Completion Date: Feb 17, 2022
• Actual Study Completion Date: Mar 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Incidence of SADEs [Up to 10 days post-procedure]

   Incidence of Serious Adverse Device Effects (SADEs)

2. Rate of Insertion Success [Procedure]

   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

1. Functionality - Lowest Defibrillation Conversion Energy [Procedure]

   Lowest Defibrillation Conversion Energy (J)

2. Observational: Incidence of ADEs [Up to 10 days post-procedure]

   Incidence of Adverse Device Effects (ADEs), Overall and Individual

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

1. 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.

2. Uncontrolled paroxysmal, persistent or permanent atrial fibrillation

3. Median or partial sternotomy

4. Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium

5. Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)

6. Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments/conditions which may complicate the EV-ICD Lead insertion procedure

7. Pericardial disease, pericarditis and mediastinitis

8. Medical treatments, surgeries or conditions that increase the potential for pericardial adhesions

9. FEV1 < 1.0 Liter

10. Surgically corrected congenital heart disease (not including catheter-based procedures)

11. Allergies to the device materials as listed in the Instructions for Use (IFU)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanatorio Italiano	Asunción		Paraguay

Sponsors and Collaborators

• AtaCor Medical, Inc.

Investigators

• Principal Investigator: Martin C Burke, DO, AtaCor Medical, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AtaCor Medical, Inc.
• ClinicalTrials.gov Identifier: NCT05099289
• Other Study ID Numbers: DOC-10154
• First Posted: Oct 29, 2021
• Last Update Posted: Jul 8, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by AtaCor Medical, Inc.: Ventricular Defibrillation
• Additional relevant MeSH terms: Tachycardia; Tachycardia, Ventricular; Ventricular Fibrillation

Study Results

No Results Posted as of Jul 8, 2022