Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04538287
Status:
COMPLETED
Last Update Posted:
2022-07-07
First Post:
2020-08-25
Brief Title:
AtaCor Subcostal Temporary Extravascular Pacing III Study
Sponsor:
AtaCor Medical Inc
Organization:
AtaCor Medical Inc
Study Overview
Official Title:
AtaCor Subcostal Temporary Extravascular Pacing III Study
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEP III
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None