Subcostal Temporary Extravascular Pacing V (STEP V) Study

AtaCor Medical, Inc.1 site in 1 country29 target enrollmentJanuary 23, 2023

ConditionsConduction Defect

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Conduction Defect
Sponsor: AtaCor Medical, Inc.
Enrollment: 29
Locations: 1
Primary Endpoint: Freedom from ADEs
Status: Completed
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 23, 2023

End Date

June 30, 2025

Last Updated

8 months ago

Study Type

Interventional

Study Design

Single Group