Subcostal Temporary Extravascular Pacing V Study

NCT05633394 | Completed

• 1 other identifier: DOC-10235
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The STEP V Study is a prospective, multicenter, acute (in-hospital), single-arm feasibility study. The objective of the study is to evaluate the early safety and performance of the latest AtaCor EV Temporary Pacing Lead System over a two-day use period.

Conditions

Conduction Defect

Keywords

Temporary Ventricular Pacing; Extravascular

Outcome Measures

Primary Outcomes (4)

• Freedom from ADEs

  Freedom from Adverse Device Effects (ADE)

  Up to 2 days post-insertion

• Pacing Capture Threshold (mA or V)

  Summary statistics for pacing capture threshold with the StealthTrac Lead from insertion through removal

  Up to 2 days post-insertion

• Impedance (Ohms)

  Summary statistics for impedance with the StealthTrac Lead from insertion through removal

  Up to 2 days post-insertion

• Sensed R-Wave Amplitude (mV)

  Summary statistics for sensed R-wave amplitude with the StealthTrac Lead from insertion through removal

  Up to 2 days post-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 indicated for closed-chest cardiac invasive procedure, including:
• 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 revision

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 (e.g., inability to perform a short walk with the Holter monitor)
• 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)

Sanatorio Italiano

Asunción, Paraguay

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: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 1, 2022
• Study Start: January 23, 2023
• Primary Completion: May 29, 2025
• Study Completion: June 30, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

PA (1)