AtaCor Subcostal Temporary Extravascular Pacing III Study

Not Applicable

Completed

• Conditions: Conduction Defect
• Interventions: Device: AtaCor StealthTrac Lead

• Registration Number: NCT04538287
• Lead Sponsor: AtaCor Medical, Inc.

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.

Study Timeline

• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-08-28
• Study First Posted: 2020-09-04
• Study Start: 2020-10-03
• Primary Completion: 2022-01-25
• Study Completion: 2022-05-11
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-05
• Last Update Posted: 2022-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AtaCor StealthTrac Lead Model AC-1012	AtaCor StealthTrac Lead	Subjects inserted with the AtaCor StealthTrac Lead Model AC-1012. This is the fourth model currently being evaluated in the study.
AtaCor StealthTrac Lead Model AC-1020	AtaCor StealthTrac Lead	Subjects inserted with the AtaCor StealthTrac Lead Model AC-1020. This was the second model evaluated in the study.
AtaCor StealthTrac Lead Model AC-1010	AtaCor StealthTrac Lead	Subjects inserted with the AtaCor StealthTrac Lead Model AC-1010. This was the first model evaluated in the study.
AtaCor StealthTrac Lead Model AC-1021	AtaCor StealthTrac Lead	Subjects inserted with the AtaCor StealthTrac Lead Model AC-1021. This was the third model evaluated in the study.

Primary Outcome Measures

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

Trial Locations

Locations (4)

Wellington Regional Hospital; 🇳🇿 Wellington, New Zealand

Christchurch Hospital; 🇳🇿 Christchurch, New Zealand

Sanatorio Italiano; 🇵🇾 Asunción, Paraguay

Na Homolce Hospital; 🇨🇿 Prague, Czechia