Subcostal Temporary Extravascular Pacing IV (STEP IV) Study (STEP IV)

The STEP IV Study is a prospective, single-center, non-randomized, single-arm study without concurrent or historical controls. The objective of the study is to generate safety and performance data of the latest AtaCor EV Temporary Pacing Lead System to support the development of a future pivotal study with an indication limited to a maximum of 7 days.

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.

One (1) Investigational Site in Paraguay will participate with up to 16 subjects enrolled in the study. Subjects indicated for a closed-chest cardiac invasive procedure will be eligible for participation. Subjects undergoing a qualifying index procedure will have a Model AC-1013 StealthTrac Lead inserted and evaluated over the follow-up period (up to 7 days post procedure). Study participation requires 2 to 7 days with the Study Lead inserted. Following Study Lead removal, a final follow-up will be performed 27-33 days after lead insertion to assess for any latent Adverse Events. Subjects remain enrolled until completion of the 30-Day Follow Up.

The maximum duration for study participation is 33 days. The Study is expected to last up to 3 months after first enrollment: Enrollment and follow-up (1 month) and final report (2 months).

• Study Type: Interventional
• Enrollment (Actual): 12
• 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
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. At least 18 years old
2. Indicated for closed-chest cardiac invasive procedure (e.g., transcatheter valve replacement, balloon valvuloplasty, permanent pacemaker implantation and pacing lead extractions/revisions)

Exclusion Criteria:

1. BMI ≥ 35 kg/m2
2. Septic shock
3. Severe anemia
4. Acute coronary syndrome within past 90 days
5. NYHA IV Functional Classification of heart failure within past 90 days
6. Circumstances that prevent data collection or follow-up (e.g., inability to perform a short walk with the Holter monitor)
7. Participation in any concurrent clinical study without prior written approval from the Sponsor

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

   Known prior history for any of the following:

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

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-1013	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 (ADEs)	Up to 7 days post-implant
Pacing Capture Threshold (V or mA)	Summary statistics for pacing capture threshold with the StealthTrac Lead from insertion through removal	Up to 7 days post-implant
Impedance (Ohms)	Summary statistics for impedance with the StealthTrac Lead from insertion through removal	Up to 7 days post-implant
Sensed R-Wave Amplitude (mV)	Summary statistics for sensed R-wave amplitude with the StealthTrac Lead from insertion through removal	Up to 7 days post-implant

Collaborators and Investigators

• Sponsor: AtaCor Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2022
• Primary Completion (Actual): September 22, 2022
• Study Completion (Actual): October 20, 2022

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Temporary Ventricular Pacing; Extravascular
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease
• Other Study ID Numbers: DOC-10200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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