Subcostal Temporary Extracardiac Pacing II Study (STEP II)

AtaCor Medical

Status: Completed

Conditions: Conduction Defect

Treatments: Device: Two StealthTrac Temporary Pacing Leads (Increased Electrode Spacing); Device: StealthTrac Lead Only (Control); Device: StealthTrac Temporary Pacing Lead Plus Negative Pressure Wound Therapy; Device: StealthTrac Temporary Pacing Lead Plus Anti-Inflammatory Glucocorticoid

Study type: Interventional

Funder types: Industry

Identifiers

NCT04374929

DOC-10084

Details and patient eligibility

About

Up to 12 subjects will be enrolled (up to 8 undergoing an AtaCor Temporary Pacing System procedure) in order to evaluate initial safety and performance of the AtaCor Temporary Pacing System when used with three (3) strategies for stabilizing AtaCor Temporary Pacing System electrical measurements over a two (2) to seven (7) day period. The three treatments are (1) Negative Pressure Wound Therapy, (2) Anti-Inflammatory Glucocorticoid and (3) increased electrode spacing. A control arm with no additional treatment is also included. Safety will be evaluated through analysis of all Adverse Events. Performance will be evaluated through (1) the incidence of successful StealthTrac Lead placement using the MACH I Delivery Tool, (2) electrical performance measurements, such as pacing capture thresholds, sensed R-wave amplitudes, pacing impedance and skeletal muscle stimulation. Appropriate sensing and pacing capture will be ascertained from ECG Holter Monitor recordings during periods of in-hospital ambulation.

Full description

Enrolled Subjects will have both a market-released transvenous pacing lead and investigational StealthTrac Temporary Pacing Lead placed and evaluated. Following StealthTrac Lead insertion, each subject will receive (1) one of three (3) study treatments intended to stabilize pacing capture thresholds and pacing impedance over time or receive no treatment. The three treatments are (1) Negative Pressure Wound Therapy, (2) Anti-Inflammatory Glucocorticoid and (3) increased electrode spacing achieved by the use of two inserted StealthTrac Leads. During the placement procedure, diagnostic echocardiograms will be performed to detect any new pericardial effusions. Once inserted, the StealthTrac Lead will be used to deliver high rate pacing (160 to 220 BPM) in clinically appropriate Subjects, to demonstrate suitability for use in transcatheter procedures that require brief periods of temporary pacing. Lead positions will be documented using fluoroscopic images before the Subject leaves the procedure room. On the following two days after the procedure, electrical performance will be evaluated in multiple postures and appropriate pacing and sensing will be confirmed during activity using ECG Holter monitor recordings. Subjects will also be asked patient-centric questions about their experience with the StealthTrac Lead throughout the study period. Evaluations will continue for a maximum of seven (7) days after the index procedure. Prior to StealthTrac Lead removal, an X-Ray will be taken to document the final lead position. A final follow-up will be performed 25-30 days after removal to identify any latent adverse events before the Subject exits the study.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Indicated for closed-chest cardiac invasive procedure that does not require full systemic anticoagulation during the procedure.

   Examples of such procedures include: transcatheter valve replacement, balloon valvuloplasty, implantable cardioverter-defibrillator (ICD) implantation, permanent pacemaker implantation and pacing lead extractions/revisions.

2. Physically and mentally capable of providing informed consent and at least 18 years of age or of legal age to provide consent as required by local and national requirements.

Exclusion criteria

1. History of a prior sternotomy (median or partial);
2. History of prior surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium;
3. History of significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis), prior chest radiation therapy or other reasons which may cause pericardial adhesions or complicate the AtaCor Temporary Pacing System insertion procedure;
4. History of pericardial disease, pericarditis or mediastinitis;
5. History of chronic obstructive pulmonary disease (COPD);
6. NYHA functional classification IV at the time of enrollment;
7. History of congenital heart disease;
8. Patients with circumstances that prevent data collection or follow-up;
9. BMI > 35 kg/m2;
10. Contraindication to glucocorticoid medication;
11. History of allergies to any study devices; and
12. Participation in any concurrent study without prior, written approval from the Sponsor.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 4 patient groups

Negative Pressure Wound Therapy

Active Comparator group

Treatment:

Device: StealthTrac Temporary Pacing Lead Plus Negative Pressure Wound Therapy

Anti-Inflammatory Glucocorticoid

Active Comparator group

Treatment:

Device: StealthTrac Temporary Pacing Lead Plus Anti-Inflammatory Glucocorticoid

Increased Electrode Spacing

Active Comparator group

Treatment:

Device: Two StealthTrac Temporary Pacing Leads (Increased Electrode Spacing)

Control

Other group

Treatment:

Device: StealthTrac Lead Only (Control)