Subcostal Temporary Extravascular Pacing V Study

NCT ID: NCT05633394

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-23
• Study Completion Date: 2025-06-30

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.

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.

Conditions

Conduction Defect

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

AtaCor EV Temporary Pacing Lead System

Subjects implanted with the AtaCor StealthTrac Lead Model AC-101400

Group Type: EXPERIMENTAL

AtaCor StealthTrac Lead

Intervention Type: DEVICE

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

Interventions

AtaCor StealthTrac Lead

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AtaCor Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin C Burke, DO

Role: PRINCIPAL_INVESTIGATOR

AtaCor Medical, Inc.

Locations

Sanatorio Italiano

Asunción, , Paraguay

Countries

Paraguay

Other Identifiers

DOC-10235

Identifier Type: -

Identifier Source: org_study_id