NCT05633394

Subcostal Temporary Extravascular Pacing V Study

Subcostal Temporary Extravascular Pacing V (STEP V) Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: AtaCor Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	AtaCor StealthTrac Lead	Subjects will receive the AtaCor StealthTrac Lead being evaluated in the study.

Timeline

• Start date: 2023-01-23
• Primary completion: 2025-05-29
• Completion: 2025-06-30
• First posted: 2022-12-01
• Last updated: 2025-08-24

Locations

1 site across 1 country: Paraguay