NCT04538287

AtaCor Subcostal Temporary Extravascular Pacing III Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: AtaCor Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Third in-human study for the AtaCor Extravascular (EV) Temporary Pacing Lead System to collect initial safety and performance data for the latest AtaCor System. The objective of the study is to generate safety and performance data of the latest AtaCor EV Temporary Pacing Lead System 1) to support the development a future pivotal study with an indication limited to a maximum of 7 days, and 2) to obtain early clinical data for future research related to longer-term use.

Detailed description

Prior revisions of the study intended to evaluate multiple StealthTrac Leads (Models AC-1010, AC-1020, AC-2021 and AC-1030) to support the development of a future pivotal study. In the most recent revision of the study, an additional StealthTrac Lead (Model AC-1012) will be evaluated to support use in a larger pivotal study. This study is a feasibility study serving dual purposes: 1) to generate developmental clinical data in support of a subsequent pivotal clinical study and marketing application for temporary pacing (in patients that retain the lead for a maximum of 7 days); and 2) to obtain early data for future research related to longer-term use (in patients that retain the lead for a maximum of 14 days). Subjects undergoing a qualifying index procedure will have a Model AC-1012 StealthTrac Lead inserted, evaluated for a Maximum Lead Insertion Time prior to removal and a final post-removal follow-up 27-33 days after lead insertion. The following elements will change after the absence of AtaCor-related cardiac tamponade and no more than one (1) serious AtaCor-related pericardial effusion has been confirmed from the initial eight (8) experiences with the Model AC-1012 StealthTrac Lead, including insertion and removal procedures performed by multiple operators: * Maximum Lead Insertion Time will change from 7 to 14 Days * Follow-up will change from in-hospital follow-up only to allowing hospital discharge with the StealthTrac lead inserted, but capped and inactive after Day 2 provided in-person wound checks occur at least every 3 days * Echocardiography requirements will transition from 3 distinct days to procedure day and removal day only.

Conditions

• Conduction Defect

Interventions

Type	Name	Description
DEVICE	AtaCor StealthTrac Lead	Subjects are assigned non-randomly to receive one of the four AtaCor StealthTrac leads being evaluated in the study.

Timeline

• Start date: 2020-10-03
• Primary completion: 2022-01-25
• Completion: 2022-05-11
• First posted: 2020-09-04
• Last updated: 2022-07-07

Locations

4 sites across 3 countries: Czechia, New Zealand, Paraguay