NCT05610033

Completed

Pilot evaluatIon Of NovEl tEmpoRary ExtraVascular PACING (PI...

AtaCor Medical, Inc.Source

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Other study identifiers

Sponsor study identifier

DOC-10219

Study Type

interventional

Actual enrollment (reported)

12

Locations

1 country

Sites

1

Timeline

Study Start

September 19, 2023

Actual (reported)

Primary Completion

December 15, 2023

Actual (reported)

Study Completion

January 12, 2024

Actual (reported)

Brief Summary

The PIONEER EV PACING Study is prospective, multi-center, acute (in-hospital), single-arm, pilot study. The study objective is to characterize preliminary safety and performance of the AtaCor EV Temporary Pacing Lead System when used as intended for clinical use as a temporary pacing lead.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 12 participants
Study completion date: January 12, 2024
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
October 30, 2022
Actual (reported)
First Posted
November 8, 2022
Actual (reported)
Study Start
September 19, 2023
Actual (reported)
Primary Completion
December 15, 2023
Actual (reported)
Study Completion
January 12, 2024
Actual (reported)

Last Updated: August 24, 2025
Status Verified: August 2025
Last Update Submitted: August 22, 2025

Conditions

Conduction Defect

Keywords

Temporary Ventricular PacingExtravascular

Outcome Measures

Primary Outcomes (2)

Freedom from severe ADEs
Freedom from Adverse Device Effects, CTCAE Grade 3 or Higher
Up to 30 days post-lead removal
Percentage of Subjects with pacing capture
Percentage of Subjects with demonstrated pacing capture following lead fixation
Up to 2 days post-lead insertion

Study Arms (1)

AtaCor EV Temporary Pacing Lead System

EXPERIMENTAL

Subjects implanted with the AtaCor StealthTrac Lead Model AC-101400

Device: AtaCor StealthTrac Lead

Interventions

AtaCor StealthTrac LeadDevice

Subjects will receive the AtaCor StealthTrac Lead being evaluated in the study.

AtaCor EV Temporary Pacing Lead System

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

At least 18 years old
Subjects who:

Sponsors & Collaborators

AtaCor Medical, Inc.
Industrylead

Study Sites (1)

University Hospital Center Split

Split, 21000, Croatia

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Martin C Burke, DO
AtaCor Medical, Inc.
PRINCIPAL INVESTIGATOR

Enrollment

12 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

October 30, 2022

First Posted

November 8, 2022

Study Start

September 19, 2023

Actual (reported)

NCT04096365

Subcostal Temporary Extracardiac Pacing Study

Not ApplicableCompleted

Are undergoing one of the following planned (non-urgent) procedures that are associated with the potential need for temporary bradycardia pacing:

Transarterial transcatheter aortic valve implantation (TAVI)

Transarterial balloon aortic valvuloplasty (BAV)

Cardiovascular implantable electronic device (CIED) pulse generator replacement

Cardiovascular implantable electronic device (CIED) lead extraction OR

Subjects with bradycardia who are under evaluation to determine if the cause is transient or permanent

You may not qualify if:

BMI ≥ 35 kg/m2
Septic shock
Severe anemia
Patients on dual antiplatelet therapy or anti-coagulation that cannot be stopped for the procedure
Circumstances that 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:
Median or partial sternotomy
Acute coronary syndrome within past 90 days
NYHA Functional Classification IV within past 90 days
Surgically corrected congenital heart disease (not including catheter-based procedures)
Allergies to the device materials such as stainless steel, titanium, platinum, iridium, polyethylene, polyurethane, polycarbonate and silicone
Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium, including adhesions
Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
+5 more criteria

Contact the study team to confirm eligibility.

Primary Completion

December 15, 2023

Actual (reported)

Study Completion

January 12, 2024

Actual (reported)

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05610033
Data provider: ClinicalTrials.gov
Source updated: 2025-08-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:25:46 UTC

Locations

HR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

AtaCor EV Temporary Pacing Lead System

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations