Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 1:35 AM
NCT ID:
NCT05633394
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.
Study:
NCT05633394
Study Brief:
Protocol Section:
NCT05633394