AtaCor Subcostal Temporary Extravascular Pacing III Study

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    50
  • sponsor
    AtaCor Medical, Inc.
Updated on 8 September 2021

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.

Description

The original intent of the study was to evaluate 3 StealthTrac Leads (Models AC-1010, AC-1020, and AC-1030) to support the development of a future pivotal study. In the most recent revision of the study, an additional fourth StealthTrac Lead (Model AC-1021) will be evaluated to support use in a larger pivotal study. Additionally, the length of time for lead retention was increased from 7 to 14 days for the purpose of gathering preliminary performance data on longer-term use.

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 are assigned non-randomly to receive one of the 4 StealthTrac Leads. Following Study Lead insertion (Day 0), Subjects must remain in the hospital at least through Day 2. Subjects provided with wound care instructions may be discharged with a non-active Study Lead on or after Day 2. Subjects must return to the Site for a follow-up visit no longer than 3 days after discharged or last follow-up. Study Leads must be removed no later than 14 days after insertion. Subjects must complete the last follow-up within 27-33 days after the Study Lead insertion.

The maximum follow-up duration specified by this protocol is initially 7 days. This maximum follow-up duration will transition to 14 days after a minimum of 8 subjects across at least 3 sites have been enrolled with the Model AC-1021 StealthTrac Lead. The Sponsor shall notify the Principal Investigator at all participating sites in writing when the maximum follow-up period has transitioned to 14 days. Prior to receiving this written notification, Subjects' participation is limited to 7 days with the Study Lead. After receiving this written notification, Subjects may choose to participate for a maximum of 14 days with the Study Lead. The transition of the maximum follow-up duration from 7 to 14 days and the transition condition shall be included in the consent information provided to all Subjects.

Details
Condition Conduction Defect, conduction disorders
Treatment AtaCor StealthTrac Lead
Clinical Study IdentifierNCT04538287
SponsorAtaCor Medical, Inc.
Last Modified on8 September 2021

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