AtaCor Subcostal Temporary Extravascular Pacing III Study

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    50
  • sponsor
    AtaCor Medical, Inc.
Updated on 22 June 2021
Investigator
Michaela Kavková
Primary Contact
Na Homolce Hospital (1.2 mi away) Contact
+4 other location

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 on22 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

At least 18 years old
Indicated for closed-chest cardiac invasive procedure (e.g. transcatheter valve replacement, balloon valvuloplasty, permanent pacemaker implantation and pacing lead extractions/revisions)

Exclusion Criteria

NYHA IV functional class
Oxygen dependency
BMI 35 kg/m2
Circumstances that prevent data collection or follow-up (e.g., inability to perform a short walk with the Holter monitor)
Participation in any concurrent clinical study without prior written approval from the Sponsor
Inability to give an informed consent to participate in the Study
Known prior history for any of the following
\. Median or partial sternotomy
\. Surgery with disruption of the lung, pericardium or connective tissue
between the sternum and pericardium
\. Significant anatomic derangement of or within the thorax (e.g., pectus
excavatum, significant scoliosis)
\. Thoracic radiation therapy, pneumothorax, pneumomediastinum or other
medical treatments/conditions which may complicate the AtaCor EV Temporary
Pacing Lead System insertion procedure
\. Pericardial disease, pericarditis and mediastinitis
\. Medical treatments, surgeries or conditions that increase the potential
for pericardial adhesions
\. Severe to very severe airflow limitation, defined as FEV1/FVC <0.7 AND
FEV1 < 50% predicted
\. Symptomatic COPD exacerbation associated with either
Modified MRC Dyspnea Scale Grade 2, OR
CAT Assessment
Surgically corrected congenital heart disease (not including catheter-based procedures)
Allergies to the device materials such as stainless steel, titanium, platinum, iridium, polyethylene, polyurethane, polycarbonate and silicone
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