Subcostal Temporary Extracardiac Pacing II Study

NCT04374929 | Completed

• 1 other identifier: DOC-10084
• Study Type: interventional
• Target: 7
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Conduction Defect

Keywords

Temporary; Ventricular; Pacing

Outcome Measures

Primary Outcomes (4)

• Safety Outcome: Number of Subjects Experiencing an Adverse Device Effect

  Number of Subjects Experiencing an Adverse Device Effect

  30 days

• Performance Outcome

  Mean Pacing Capture Threshold (V)

  Up to 7 days post insertion

• Performance Outcome

  Mean Pacing Impedance (Ohms)

  Up to 7 days post insertion

• Performance Outcome

  Mean R-Wave Amplitude (mV)

  Up to 7 days post insertion

Study Arms (4)

Negative Pressure Wound Therapy

ACTIVE COMPARATOR

Device: StealthTrac Temporary Pacing Lead Plus Negative Pressure Wound Therapy

Anti-Inflammatory Glucocorticoid

ACTIVE COMPARATOR

Device: StealthTrac Temporary Pacing Lead Plus Anti-Inflammatory Glucocorticoid

Increased Electrode Spacing

ACTIVE COMPARATOR

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

Control

OTHER

Device: StealthTrac Lead Only (Control)

Interventions

StealthTrac Temporary Pacing Lead Plus Negative Pressure Wound Therapy DEVICE

Following fixation of the StealthTrac Lead, Negative Pressure Wound Therapy is applied over the incision site.

Negative Pressure Wound Therapy

StealthTrac Temporary Pacing Lead Plus Anti-Inflammatory Glucocorticoid DEVICE

• Methylprednisolone 125 mg administered over 30 minutes beginning at least 30 minutes prior to the incision and StealthTrac Lead insertion procedure. This intravenous dose can be repeated every 8 hours on day one of the insertion from 1-3 doses depending on the patient's ability to take oral medications. It can be administered daily thereafter until the patient is able to take oral dosing. In normal circumstances, post op day 2, commence oral glucocorticoid (see below for recommended oral dosing). Oral (PO) glucocorticoid preparations and dosing: * Prednisone 40-60 mg orally daily based on BMI category. BMI categories: Low (\<18); Medium (18-30); High (\>30). Low and medium are assigned 40 mg daily. High BMI is assigned 60 mg daily dose. This while the StealthTrac lead remains in place. * Methylprednisolone 16-32 mg daily based on BMI (low, medium and high) while the StealthTrac Lead remains in place.

Anti-Inflammatory Glucocorticoid

Two StealthTrac Temporary Pacing Leads (Increased Electrode Spacing) DEVICE

Once the first StealthTrac Lead is placed using the procedure described in the AtaCor Temporary Pacing System Instructions for Use (DOC-10085), load a second StealthTrac Lead into the same MACH I Delivery Tool, unless it was damaged during insertion of the first StealthTrac Lead, in which case a new MACH I Delivery Tool should be used. Insert the second StealthTrac Lead through (1) a different intercostal muscle path within the same intercostal space or (2) within an adjacent intercostal space. Increased electrode spacing is achieved by pacing between the leads.

Increased Electrode Spacing

StealthTrac Lead Only (Control) DEVICE

A single StealthTrac Lead is placed with no additional treatment.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• History of a prior sternotomy (median or partial);
• History of prior surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium;
• 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;
• History of pericardial disease, pericarditis or mediastinitis;
• History of chronic obstructive pulmonary disease (COPD);
• NYHA functional classification IV at the time of enrollment;
• History of congenital heart disease;
• Patients with circumstances that prevent data collection or follow-up;
• BMI \> 35 kg/m2;
• Contraindication to glucocorticoid medication;
• History of allergies to any study devices; and
• Participation in any concurrent study without prior, written approval from the Sponsor.

Sponsors & Collaborators

• AtaCor Medical, Inc.: lead

Study Sites (2)

Christchurch Hospital

Christchurch, New Zealand

Location

Sanatorio Italiano

Asunción, Paraguay

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Martin Burke, D.O.

  AtaCor Medical

  PRINCIPAL INVESTIGATOR

• Adrian Ebner, M.D.

  Sanatorio Italiano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 5, 2020
• Study Start: July 28, 2020
• Primary Completion: December 15, 2020
• Study Completion: May 14, 2021
• Last Updated: June 11, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); PA (1)