Pilot evaluatIon Of NovEl tEmpoRary ExtraVascular PACING (PIONEER EV PACING) Study

NCT05610033 | Completed

• 1 other identifier: DOC-10219
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Conduction Defect

Keywords

Temporary Ventricular Pacing; Extravascular

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 Lead DEVICE

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

AtaCor EV Temporary Pacing 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
• Subjects who:
• 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)

Sponsors & Collaborators

• AtaCor Medical, Inc.: lead

Study Sites (1)

University Hospital Center Split

Split, 21000, Croatia

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; 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: 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
• Primary Completion: December 15, 2023
• Study Completion: January 12, 2024
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)