Subcostal Temporary Extravascular Pacing V Study — STEP V  

Conduction Defect Clinical Trial

Official title: Subcostal Temporary Extravascular Pacing V (STEP V) Study

Status Recruiting

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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Conduction Defect

• NCT number: NCT05633394
• Study type: Interventional
• Source: AtaCor Medical, Inc.
• Contact: Michael Husby, MS, MPH
• Phone: +1 949-392-8988
• Email: michael@atacor.com
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2023
• Completion date: May 25, 2024