Clinical trial NCT04538287: AtaCor Subcostal Temporary Extravascular Pacing III Study
Official title: AtaCor Subcostal Temporary Extravascular Pacing III Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conduction Defect
Keywords: Temporary Ventricular Pacing
Lead sponsor: AtaCor Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-04
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. NYHA IV functional class
2. Oxygen dependency
3. BMI ≥ 35 kg/m2
4. Circumstances that prevent data collection or follow-up (e.g., inability to perform a short walk with the Holter monitor)
5. Participation in any concurrent clinical study without prior written approval from the Sponsor
6. Inability to give an informed consent to participate in the Study

   Known prior history for any of the following:
7. Median or partial sternotomy
8. Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium
9. Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
10. Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments/conditions which may complicate the AtaCor EV Temporary Pacing Lead System insertion procedure
11. Pericardial disease, pericarditis and mediastinitis
12. Medical treatments, surgeries or conditions that increase the potential for pericardial adhesions
13. Severe to very severe airflow limitation, defined as FEV1/FVC \<0.7 AND FEV1 \< 50% predicted
14. Symptomatic COPD exacerbation associated with either:

    1. Modified MRC Dyspnea Scale Grade ≥2, OR
    2. CAT Assessment
15. Surgically corrected congenital heart disease (not including catheter-based procedures)
16. Allergies to the device materials such as stainless steel, titanium, platinum, iridium, polyethylene, polyurethane, polycarbonate and silicone

Primary outcomes:
measure: Safety - Freedom from Adverse Device Effects
timeFrame: Lead removal (up to 14 Days)
measure: Performance - Pacing Capture Threshold
timeFrame: Lead removal (up to 14 Days)
measure: Performance - Pacing Impedance
timeFrame: Lead removal (up to 14 Days)
measure: Performance - Sensed R-wave Amplitude
timeFrame: Lead removal (up to 14 Days)
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Na Homolce Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Wellington
country: New Zealand
facility: Wellington Regional Hospital
city: Asunción
country: Paraguay
facility: Sanatorio Italiano
Study officials:
affiliation: AtaCor Medical, Inc.
name: Martin C Burke, DO
role: PRINCIPAL_INVESTIGATOR
References: