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Subcostal Temporary Extracardiac Pacing Study (STEP)

Primary Purpose

Conduction Defect

Status

Completed

Phase

Not Applicable

Locations

Paraguay

Study Type

Interventional

Intervention

Subcostal Temporary Extracardiac Pacing Lead

About this trial

This is an interventional basic science trial for Conduction Defect focused on measuring Temporary, Ventricular, Pacing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Contraindicated or clinically unsuitable for transvenous lead placement;
Implanted with an implantable cardioverter defibrillator (ICD) or transvenous defibrillation lead at the time of enrollment;
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 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;
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, including conditions that prevent ambulation and testing in multiple postures;
BMI ≥ 35 kg/m2;
History of allergies to any study device components;
Pregnant or lactating (current or anticipated during study follow up); and
Participation in any concurrent study without prior, written approval from the Sponsor.

Sites / Locations

Sanatorio Italiano

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subcostal temporary extracardiac pacing lead

Arm Description

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

Outcomes

Primary Outcome Measures

Safety Outcome: Number of Subjects Experiencing an Adverse Device Effect

Safety will be evaluated through analysis of all Adverse Device Effects

Performance Outcome: Mean Pacing Capture Threshold (V)

Minimum current required to pacing the heart (in multiple postures)

Performance Outcome: Mean Pacing Impedance (Ohms)

Impedance measured while pacing the heart (in multiple postures)

Performance Outcome: Mean R-Wave Amplitude (mV)

R-Wave amplitudes measured while sensing the heart (in multiple postures)

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04096365

First Posted

September 17, 2019

Last Updated

February 1, 2021

Sponsor

AtaCor Medical, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04096365

Brief Title

Subcostal Temporary Extracardiac Pacing Study

Acronym

STEP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

August 25, 2019 (Actual)

Primary Completion Date

November 7, 2019 (Actual)

Study Completion Date

November 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AtaCor Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Conduction Defect

Keywords

Temporary, Ventricular, Pacing

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Subcostal temporary extracardiac pacing lead

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Subcostal Temporary Extracardiac Pacing Lead

Intervention Description

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.

Primary Outcome Measure Information:

Title

Safety Outcome: Number of Subjects Experiencing an Adverse Device Effect

Description

Safety will be evaluated through analysis of all Adverse Device Effects

Time Frame

30 days

Title

Performance Outcome: Mean Pacing Capture Threshold (V)

Description

Minimum current required to pacing the heart (in multiple postures)

Time Frame

Up to 2 days post insertion

Title

Performance Outcome: Mean Pacing Impedance (Ohms)

Description

Impedance measured while pacing the heart (in multiple postures)

Time Frame

Up to 2 days post insertion

Title

Performance Outcome: Mean R-Wave Amplitude (mV)

Description

R-Wave amplitudes measured while sensing the heart (in multiple postures)

Time Frame

Up to 2 days post insertion

Title

Performance Outcome: % of R-R Intervals With Appropriate Pacing and Sensing During Activity

Description

Time Frame

Up to 2 days post insertion

Other Pre-specified Outcome Measures:

Title

Paced QRS Duration (ms)

Description

QRS duration measured from 12-Lead ECG

Time Frame

1 day after insertion

Title

Echocardiographic Assessment of Left Ventricular Stroke Volume During Pacing (mL)

Description

Measures of cardiac function obtained from echocardiography

Time Frame

2 days after insertion

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Physically and mentally capable of providing informed consent. At least 18 years of age or of legal age to provide consent as required by local and national requirements. Exclusion Criteria: Contraindicated or clinically unsuitable for transvenous lead placement; Implanted with an implantable cardioverter defibrillator (ICD) or transvenous defibrillation lead at the time of enrollment; 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 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; 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, including conditions that prevent ambulation and testing in multiple postures; BMI ≥ 35 kg/m2; History of allergies to any study device components; Pregnant or lactating (current or anticipated during study follow up); and Participation in any concurrent study without prior, written approval from the Sponsor.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Burke, D.O.

Organizational Affiliation

AtaCor Medical

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Adrian Ebner, M.D.

Organizational Affiliation

Sanatorio Italiano

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sanatorio Italiano

City

Asunción

Country

Paraguay

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.atacor.com/

Description

Sponsor website

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Subcostal Temporary Extracardiac Pacing Study

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