Evaluating a new temporary pacing lead system for heart procedures

Subcostal Temporary Extravascular Pacing V (STEP V) Study

This study is testing a new temporary heart pacing lead to see if it is safe and works well for people undergoing heart procedures.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AtaCor Medical, Inc. (industry)
• Drugs / interventions: radiation
• Locations: 1 site (Asunción)
• Trial ID: NCT05633394 on ClinicalTrials.gov

What this trial studies

This study is a multicenter, acute feasibility assessment of the AtaCor EV Temporary Pacing Lead System, focusing on its safety and performance over a two-day period. Participants will have the StealthTrac Lead inserted during a closed-chest cardiac invasive procedure and will be monitored for adverse effects and performance metrics such as pacing capture threshold and impedance. The study aims to enroll up to 50 subjects across three investigational sites, with follow-up assessments conducted for 30 days post lead removal to track any latent adverse events.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are indicated for closed-chest cardiac invasive procedures.

Not a fit: Patients with a BMI of 35 kg/m2 or higher, septic shock, or severe anemia may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the safety and effectiveness of temporary pacing in patients undergoing cardiac procedures.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in evaluating temporary pacing systems, suggesting potential for success.

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

Where this trial is running

Asunción

• Sanatorio Italiano — Asunción, Paraguay (RECRUITING)

Study contacts

• Principal investigator: Martin C Burke, DO — AtaCor Medical, Inc.
• Study coordinator: Michael Husby, MS, MPH

Conditions: Conduction Defect, Temporary Ventricular Pacing, Extravascular