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

Not Applicable

Completed

• Conditions: Ventricular Arrhythmia; Ventricular Tachycardia; Ventricular Fibrillation
• Interventions: Device: AtaCor EV-ICD Lead

• Registration Number: NCT05099289
• Lead Sponsor: AtaCor Medical, Inc.

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.

Study Timeline

• Study First Submitted: 2021-09-29
• Study First Submitted QC: 2021-10-18
• Study First Posted: 2021-10-29
• Study Start: 2021-11-17
• Primary Completion: 2022-02-17
• Study Completion: 2022-03-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-05
• Last Update Posted: 2022-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AtaCor EV-ICD Lead System	AtaCor EV-ICD Lead	Subjects inserted with the AtaCor EV-ICD Lead Model AC-7000

Primary Outcome Measures

Name	Time	Method
Incidence of SADEs	Up to 10 days post-procedure	Incidence of Serious Adverse Device Effects (SADEs)
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

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

Trial Locations

Locations (1)

Sanatorio Italiano; 🇵🇾 Asunción, Paraguay