Subcostal Temporary Extravascular Pacing V Study

Conduction Defect Clinical Trial

— STEP V  

Official title:

Subcostal Temporary Extravascular Pacing V (STEP V) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05633394
• Other study ID #: DOC-10235
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2023
• Est. completion date: May 25, 2024

Study information

• Verified date: April 2024
• Source: AtaCor Medical, Inc.
• Contact: Michael Husby, MS, MPH
• Phone: +1 949-392-8988
• Email: michael[@]atacor.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 with Subjects restricted to bedrest. Lead performance will also be evaluated without bedrest restrictions in the limited period shortly before lead removal on the last follow-up day.

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 16 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. The Study is expected to last up to 3 months after first enrollment: Enrollment and follow-up (1 month) and final report (2 months).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: May 25, 2024
• Est. primary completion date: April 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Conduction Defect

Intervention

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

Locations

Country	Name	City	State
Paraguay	Sanatorio Italiano	Asunción

Sponsors (1)

Lead Sponsor	Collaborator
AtaCor Medical, Inc.

Country where clinical trial is conducted

Paraguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from ADEs	Freedom from Adverse Device Effects (ADE)	Up to 2 days post-insertion
Primary	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
Primary	Impedance (Ohms)	Summary statistics for impedance with the StealthTrac Lead from insertion through removal	Up to 2 days post-insertion
Primary	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