AtaCor Subcostal Temporary Extravascular Pacing III Study

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.

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