Clinical trialNCT05791032CompletedInterventional

Sub Chronic Evaluation for ATP With an Extravascular Placed ICD Lead (STEP ICD) Study

SponsorAtaCor Medical, Inc.Enrollment21Ventricular ArrythmiaVentricular FibrillationVentricular Tachycardia

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Martin C Burke, DO
AtaCor Medical, Inc.
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Paraguay

Sanatorio Italiano
Asunción, Paraguay

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 5 Sept 2023
Primary completion: 22 Feb 2024
Completion: 19 Mar 2024
Last update posted: 3 Apr 2024
Registered enrollment: 21
Registry id: NCT05791032

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.