Pilot evaluatIon Of NovEl tEmpoRary ExtraVascular PACING (PIONEER EV PACING) Study
NCT05610033 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2025-08-24
Summary
The PIONEER EV PACING Study is prospective, multi-center, acute (in-hospital), single-arm, pilot study. The study objective is to characterize preliminary safety and performance of the AtaCor EV Temporary Pacing Lead System when used as intended for clinical use as a temporary pacing lead.
Conditions
- Conduction Defect
Interventions
- DEVICE
-
AtaCor StealthTrac Lead
Subjects will receive the AtaCor StealthTrac Lead being evaluated in the study.
Sponsors & Collaborators
-
AtaCor Medical, Inc.
lead INDUSTRY
Principal Investigators
-
Martin C Burke, DO · AtaCor Medical, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-19
- Primary Completion
- 2023-12-15
- Completion
- 2024-01-12
Countries
- Croatia
Study Locations
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