AtaCor Subcostal Temporary Extravascular Pacing III Study

Conduction Defect Clinical Trial

— STEP III  

Official title:

AtaCor Subcostal Temporary Extravascular Pacing III Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04538287
• Other study ID #: DOC-10092
• Status: Completed
• Phase: N/A
• Start date: October 3, 2020
• Est. completion date: May 11, 2022

Study information

• Verified date: July 2022
• Source: AtaCor Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 11, 2022
• Est. primary completion date: January 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Conduction Defect

Intervention

Device:
• AtaCor StealthTrac Lead
Subjects are assigned non-randomly to receive one of the four AtaCor StealthTrac leads being evaluated in the study.

Locations

Country	Name	City	State
Czechia	Na Homolce Hospital	Prague
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Wellington Regional Hospital	Wellington
Paraguay	Sanatorio Italiano	Asunción

Sponsors (1)

Lead Sponsor	Collaborator
AtaCor Medical, Inc.

Countries where clinical trial is conducted

Czechia,  New Zealand,  Paraguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Freedom from Adverse Device Effects	Freedom from Adverse Device Effects (ADE)	Lead removal (up to 14 Days)
Primary	Performance - Pacing Capture Threshold	Summary statistics for pacing capture threshold for each StealthTrac Lead model from insertion through removal	Lead removal (up to 14 Days)
Primary	Performance - Pacing Impedance	Summary statistics for pacing impedance for each StealthTrac Lead model from insertion through removal for each StealthTrac Lead model from insertion through removal	Lead removal (up to 14 Days)
Primary	Performance - Sensed R-wave Amplitude	Summary statistics for sensed R-wave amplitude for each StealthTrac Lead model from insertion through removal	Lead removal (up to 14 Days)