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

NCT05099289 | Completed

• 1 other identifier: DOC-10154
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Arrhythmia; Ventricular Tachycardia; Ventricular Fibrillation

Keywords

Ventricular Defibrillation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Functionality - Lowest Defibrillation Conversion Energy

  Procedure

• Observational: Incidence of ADEs

  Up to 10 days post-procedure

Study Arms (1)

AtaCor EV-ICD Lead System

EXPERIMENTAL

Subjects inserted with the AtaCor EV-ICD Lead Model AC-7000

Device: AtaCor EV-ICD Lead

Interventions

AtaCor EV-ICD Lead DEVICE

Subjects will receive the AtaCor EV-ICD Lead being evaluated in the study.

AtaCor EV-ICD Lead System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old
• Indicated for de novo or replacement ICD procedure

You may not qualify if:

• 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)

Sponsors & Collaborators

• AtaCor Medical, Inc.: lead

Study Sites (1)

Sanatorio Italiano

Asunción, Paraguay

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin C Burke, DO

  AtaCor Medical, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 29, 2021
• Study Start: November 17, 2021
• Primary Completion: February 17, 2022
• Study Completion: March 31, 2022
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)