Subcostal Temporary Extravascular Pacing IV (STEP IV) Study

Conduction Defect Clinical Trial

— STEP IV  

Official title:

Subcostal Temporary Extravascular Pacing IV (STEP IV) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05457673
• Other study ID #: DOC-10200
• Status: Completed
• Phase: N/A
• Start date: August 17, 2022
• Est. completion date: October 20, 2022

Study information

• Verified date: March 2023
• Source: AtaCor Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 20, 2022
• Est. primary completion date: September 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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 (ADEs)	Up to 7 days post-implant
Primary	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
Primary	Impedance (Ohms)	Summary statistics for impedance with the StealthTrac Lead from insertion through removal	Up to 7 days post-implant
Primary	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