Subcostal Temporary Extravascular Pacing V Study (STEP V)

Subcostal Temporary Extravascular Pacing V (STEP V) Study

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.

Study Overview

• Status: Completed
• Conditions: Conduction Defect
• Intervention / Treatment: Device: AtaCor StealthTrac Lead

Detailed Description

The primary safety objective is freedom from Adverse Device Effects (ADE). The primary performance objective is summary statistics for pacing capture threshold, impedance, and sensed R-wave amplitude with the StealthTrac Lead from insertion through removal.

Up to three (3) Investigational Sites will participate with up to 50 subjects enrolled in the study. Subjects indicated for closed-chest cardiac invasive procedures will be eligible for participation. Subjects undergoing a qualifying index procedure will have a Model AC-101400 StealthTrac Lead inserted and evaluated over the follow-up period. Subject participation is expected to be 2 days with the Study Lead inserted, plus 30 days post lead removal. A 30 day (+/-3 days) post-removal follow-up will also be performed to document any latent adverse events. Subjects remain enrolled until completion of the 30-Day Follow Up.

The maximum duration for study participation is 33 days. Study duration estimated to be 3 years after the first study enrollment.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Paraguay
  • Asunción, Paraguay
    • Sanatorio Italiano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

1. At least 18 years old

2. 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

Exclusion criteria

1. BMI ≥ 35 kg/m2
2. Septic shock
3. Severe anemia
4. Patients on dual antiplatelet therapy or anti-coagulation that cannot be stopped for the procedure
5. Circumstances that prevent data collection or follow-up (e.g., inability to perform a short walk with the Holter monitor)
6. Participation in any concurrent clinical study without prior written approval from the Sponsor

7. Inability or unwillingness to provide informed consent to participate in the Study

   Known prior history for any of the following:

8. Median or partial sternotomy
9. Acute coronary syndrome within past 90 days
10. NYHA Functional Classification IV within past 90 days
11. Surgically corrected congenital heart disease (not including catheter-based procedures)
12. Allergies to the device materials such as stainless steel, titanium, platinum, iridium, polyethylene, polyurethane, polycarbonate and silicone
13. Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium, including adhesions
14. Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
15. Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments which may complicate the AtaCor EV Temporary Pacing Lead System insertion procedure
16. Any conditions which may complicate the AtaCor EV Temporary Pacing Lead System insertion procedure
17. Pericardial disease, pericarditis and mediastinitis
18. Medical treatments, surgeries or conditions that increase the potential for pericardial adhesions
19. FEV1 < 1 liter

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AtaCor EV Temporary Pacing Lead System; Subjects implanted with the AtaCor StealthTrac Lead Model AC-101400	Device: AtaCor StealthTrac Lead; Subjects will receive the AtaCor StealthTrac Lead being evaluated in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: AtaCor Medical, Inc.
• Investigators: Principal Investigator: Martin C Burke, DO, AtaCor Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2023
• Primary Completion (Actual): May 29, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: November 22, 2022
• First Posted (Actual): December 1, 2022

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Temporary Ventricular Pacing; Extravascular
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Cardiac Conduction System Disease
• Other Study ID Numbers: DOC-10235

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No