Subcostal Temporary Extravascular Pacing V Study

Not Applicable

Recruiting

• Conditions: Conduction Defect
• Interventions: Device: AtaCor StealthTrac Lead

• Registration Number: NCT05633394
• Lead Sponsor: AtaCor Medical, Inc.

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 Timeline

• Study First Submitted: 2022-11-22
• Study First Submitted QC: 2022-11-22
• Study First Posted: 2022-12-01
• Study Start: 2023-01-23
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-11
• Primary Completion: 2025-08-25
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AtaCor EV Temporary Pacing Lead System	AtaCor StealthTrac Lead	Subjects implanted with the AtaCor StealthTrac Lead Model AC-101400

Primary Outcome Measures

Name	Time	Method
Freedom from ADEs	Up to 2 days post-insertion	Freedom from Adverse Device Effects (ADE)
Sensed R-Wave Amplitude (mV)	Up to 2 days post-insertion	Summary statistics for sensed R-wave amplitude with the StealthTrac Lead from insertion through removal
Pacing Capture Threshold (mA or V)	Up to 2 days post-insertion	Summary statistics for pacing capture threshold with the StealthTrac Lead from insertion through removal
Impedance (Ohms)	Up to 2 days post-insertion	Summary statistics for impedance with the StealthTrac Lead from insertion through removal

Trial Locations

Locations (1)

Sanatorio Italiano; 🇵🇾 Asunción, Paraguay