Subcostal Temporary Extracardiac Pacing Study (STEP)

Subcostal Temporary Extracardiac Pacing Study: Clinical Study of the AtaCor Extracardiac Pacing System

Up to 15 subjects will be enrolled to evaluate initial safety and performance of the AtaCor Temporary Pacing System. 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 at rest. Appropriate sensing and pacing capture will be ascertained from ECG Holter Monitor recordings during periods of in-hospital ambulation.

Study Overview

• Status: Completed
• Conditions: Conduction Defect
• Intervention / Treatment: Device: Subcostal Temporary Extracardiac Pacing Lead

Detailed Description

Enrolled Subjects will have both a market-released transvenous pacing lead and investigational StealthTrac Temporary Pacing Lead placed and evaluated. 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 minimum of two (2) and 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 and diagnostic echocardiography will be performed to (1) detect any latent pericardial effusions and (2) assess differences in cardiac function with intrinsic conduction and while pacing. A final follow-up will be performed 25-30 days after removal to identify any latent adverse events before the Subject exits the study.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Paraguay
  • Asunción, Paraguay
    • Sanatorio Italiano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Indicated for closed-chest cardiac invasive procedure with the potential for intra-procedural or post-procedural bradycardia and willing to be hospitalized for a minimum of 2 days post procedure.

   Examples of such procedures include: transfemoral transcatheter aortic valve replacement (TAVR), balloon valvuloplasty, permanent pacemaker implantation and pacing lead extractions/revisions.

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

Exclusion Criteria:

1. Contraindicated or clinically unsuitable for transvenous lead placement;
2. Implanted with an implantable cardioverter defibrillator (ICD) or transvenous defibrillation lead at the time of enrollment;
3. History of a prior sternotomy (median or partial);
4. History of prior surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium;
5. History of significant anatomic derangement of the thorax (e.g., pectus excavatum), prior chest radiation therapy or other reasons which may cause pericardial adhesions or complicate the AtaCor Temporary Pacing System insertion procedure;
6. History of pericardial disease, pericarditis or mediastinitis;
7. History of chronic obstructive pulmonary disease (COPD);
8. NYHA functional classification IV at the time of enrollment;
9. History of congenital heart disease;
10. Patients with circumstances that prevent data collection or follow-up, including conditions that prevent ambulation and testing in multiple postures;
11. BMI ≥ 35 kg/m2;
12. History of allergies to any study device components;
13. Pregnant or lactating (current or anticipated during study follow up); and
14. Participation in any concurrent study without prior, written approval from the Sponsor.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Subcostal temporary extracardiac pacing lead; All subjects will receive a subcostal temporary extracardiac pacing lead for a minimum of 48 hours in-hospital and undergo all protocol testing.

Device: Subcostal Temporary Extracardiac Pacing Lead; The StealthTrac Lead is designed to facilitate extracardiac temporary ventricular pacing and sensing. The distal end of the StealthTrac Lead is designed to reside within the connective tissue of the anterior mediastinum outside the pericardium. The StealthTrac Lead is delivered using the MACH I Delivery Tool, which is designed to facilitate insertion of the StealthTrac Lead through a small skin incision parallel to the sternum, without the need for fluoroscopic guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Outcome: Number of Subjects Experiencing an Adverse Device Effect	Safety will be evaluated through analysis of all Adverse Device Effects	30 days
Performance Outcome: Mean Pacing Capture Threshold (V)	Minimum current required to pacing the heart (in multiple postures)	Up to 2 days post insertion
Performance Outcome: Mean Pacing Impedance (Ohms)	Impedance measured while pacing the heart (in multiple postures)	Up to 2 days post insertion
Performance Outcome: Mean R-Wave Amplitude (mV)	R-Wave amplitudes measured while sensing the heart (in multiple postures)	Up to 2 days post insertion
Performance Outcome: % of R-R Intervals With Appropriate Pacing and Sensing During Activity	ECG Holter Recordings obtained during periods of rest and in-hospital activity. The % of R-R intervals with appropriate pacing is calculated as the number of paced intervals that demonstrate pacing capture / the total number of pacing intervals. The % of R-R intervals with appropriate sensing is calculated as the number of intervals where pacing is appropriately delivered or inhibited (depending on the programmed settings of the pacemaker) / the total number of R-R intervals. The outcomes are presented a % of intervals and not an average of the percentages observed across patients.	Up to 2 days post insertion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Paced QRS Duration (ms)	QRS duration measured from 12-Lead ECG	1 day after insertion
Echocardiographic Assessment of Left Ventricular Stroke Volume During Pacing (mL)	Measures of cardiac function obtained from echocardiography	2 days after insertion

Collaborators and Investigators

• Sponsor: AtaCor Medical, Inc.
• Investigators: Principal Investigator: Martin Burke, D.O., AtaCor Medical; Principal Investigator: Adrian Ebner, M.D., Sanatorio Italiano

Publications and helpful links

Helpful Links

• Sponsor website

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 25, 2019
• Primary Completion (ACTUAL): November 7, 2019
• Study Completion (ACTUAL): November 7, 2019

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: September 18, 2019
• First Posted (ACTUAL): September 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Ventricular; Pacing; Temporary
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease
• Other Study ID Numbers: DOC-10052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes