NCT05791032

Brief Summary

STEP ICD is a premarket, exploratory, early feasibility, interventional study designed to evaluate the preliminary safety and performance of the Investigational Devices. The study is intended to inform the final device design which will be further evaluated in traditional feasibility and /or pivotal clinical investigations. The primary safety objective is to characterize safety of the EV-ICD Lead through 3 months post-implant. The primary performance objective is to characterize sensing and conversion of induced VF with the EV-ICD Lead up to 3 months post-implant.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

September 5, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2024

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2024

Completed
Last Updated

April 3, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

March 17, 2023

Last Update Submit

April 2, 2024

Conditions

Ventricular ArrythmiaVentricular TachycardiaVentricular Fibrillation

Keywords

Ventricular DefibrillationExtravascular

Outcome Measures

Primary Outcomes (2)

  • Incidence of ADEs

    Incidence of Adverse Device Effects (ADEs)

    Up to 3 months post-implant

  • Induced VF Conversion Success

    Induced VF conversion success up to 3 months post-implant

    Up to 3 months post-implant

Study Arms (1)

AtaCor EV-ICD Lead System

EXPERIMENTAL

Subjects implanted with the AtaCor EV-ICD Lead

Device: AtaCor EV-ICD Lead

Interventions

AtaCor EV-ICD LeadDEVICE

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

AtaCor EV-ICD Lead System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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:

  • BMI ≥ 35 kg/m2
  • Subjects who require continual ventricular pacing
  • Presence or planned use of a subcutaneous ICD lead, subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads within the study period
  • Planned MRI within the study period
  • Subjects on anticoagulation or antiplatelet therapy that cannot be temporarily discontinued for the procedure
  • Circumstances that may prevent data collection or follow-up
  • Participation in any concurrent clinical study without prior written approval from the Sponsor
  • Inability or unwillingness to provide informed consent to participate in the Study
  • Known prior history for any of the following:
  • NYHA IV functional class in past 90 days
  • Inotropic therapy in past 180 days
  • Structural abnormalities of the heart that may increase risk of the study procedure or an obstructed/restricted pathway into the mediastinum
  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanatorio Italiano

Asunción, Paraguay

Location

Related Publications (1)

  • Doshi SK, Knops RE, Ebner A, Husby M, Marcovecchio A, Sanghera R, Scheck D, Burke MC. Evaluation of a second-generation intercostal extravascular implantable cardioverter defibrillator lead with a pectoral pulse generator for sensing, defibrillation, and anti-tachycardia pacing. Europace. 2025 Mar 5;27(3):euaf044. doi: 10.1093/europace/euaf044.

    PMID: 40037337DERIVED

MeSH Terms

Conditions

Tachycardia, VentricularVentricular Fibrillation

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological 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

March 17, 2023

First Posted

March 30, 2023

Study Start

September 5, 2023

Primary Completion

February 22, 2024

Study Completion

March 19, 2024

Last Updated

April 3, 2024

Record last verified: 2024-04

Locations

PA(1)