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AtaCor Subcostal Temporary Extravascular Pacing III Study (STEP III)

Primary Purpose

Conduction Defect

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

AtaCor StealthTrac 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)All SexesDoes not accept healthy volunteers

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:
1. Modified MRC Dyspnea Scale Grade ≥2, OR
2. 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

Sites / Locations

Na Homolce Hospital
Christchurch Hospital
Wellington Regional Hospital
Sanatorio Italiano

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

AtaCor StealthTrac Lead Model AC-1010

AtaCor StealthTrac Lead Model AC-1020

AtaCor StealthTrac Lead Model AC-1021

AtaCor StealthTrac Lead Model AC-1012

Arm Description

Subjects inserted with the AtaCor StealthTrac Lead Model AC-1010. This was the first model evaluated in the study.

Subjects inserted with the AtaCor StealthTrac Lead Model AC-1020. This was the second model evaluated in the study.

Subjects inserted with the AtaCor StealthTrac Lead Model AC-1021. This was the third model evaluated in the study.

Subjects inserted with the AtaCor StealthTrac Lead Model AC-1012. This is the fourth model currently being evaluated in the study.

Outcomes

Primary Outcome Measures

Safety - Freedom from Adverse Device Effects

Freedom from Adverse Device Effects (ADE)

Performance - Pacing Capture Threshold

Summary statistics for pacing capture threshold for each StealthTrac Lead model from insertion through removal

Performance - Pacing Impedance

Summary statistics for pacing impedance for each StealthTrac Lead model from insertion through removal for each StealthTrac Lead model from insertion through removal

Performance - Sensed R-wave Amplitude

Summary statistics for sensed R-wave amplitude for each StealthTrac Lead model from insertion through removal

Secondary Outcome Measures

Full Information

NCT ID

NCT04538287

First Posted

August 25, 2020

Last Updated

July 5, 2022

Sponsor

AtaCor Medical, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04538287

Brief Title

AtaCor Subcostal Temporary Extravascular Pacing III Study

Acronym

STEP III

Official Title

AtaCor Subcostal Temporary Extravascular Pacing III Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

October 3, 2020 (Actual)

Primary Completion Date

January 25, 2022 (Actual)

Study Completion Date

May 11, 2022 (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

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

Third in-human study for the AtaCor Extravascular (EV) Temporary Pacing Lead System to collect initial safety and performance data for the latest AtaCor System. The objective of the study is to generate safety and performance data of the latest AtaCor EV Temporary Pacing Lead System 1) to support the development a future pivotal study with an indication limited to a maximum of 7 days, and 2) to obtain early clinical data for future research related to longer-term use.

Detailed Description

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.

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

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AtaCor StealthTrac Lead Model AC-1010

Arm Type

Active Comparator

Arm Description

Subjects inserted with the AtaCor StealthTrac Lead Model AC-1010. This was the first model evaluated in the study.

Arm Title

AtaCor StealthTrac Lead Model AC-1020

Arm Type

Active Comparator

Arm Description

Subjects inserted with the AtaCor StealthTrac Lead Model AC-1020. This was the second model evaluated in the study.

Arm Title

AtaCor StealthTrac Lead Model AC-1021

Arm Type

Active Comparator

Arm Description

Subjects inserted with the AtaCor StealthTrac Lead Model AC-1021. This was the third model evaluated in the study.

Arm Title

AtaCor StealthTrac Lead Model AC-1012

Arm Type

Active Comparator

Arm Description

Subjects inserted with the AtaCor StealthTrac Lead Model AC-1012. This is the fourth model currently being evaluated in the study.

Intervention Type

Device

Intervention Name(s)

AtaCor StealthTrac Lead

Intervention Description

Subjects are assigned non-randomly to receive one of the four AtaCor StealthTrac leads being evaluated in the study.

Primary Outcome Measure Information:

Title

Safety - Freedom from Adverse Device Effects

Description

Freedom from Adverse Device Effects (ADE)

Time Frame

Lead removal (up to 14 Days)

Title

Performance - Pacing Capture Threshold

Description

Summary statistics for pacing capture threshold for each StealthTrac Lead model from insertion through removal

Time Frame

Lead removal (up to 14 Days)

Title

Performance - Pacing Impedance

Description

Summary statistics for pacing impedance for each StealthTrac Lead model from insertion through removal for each StealthTrac Lead model from insertion through removal

Time Frame

Lead removal (up to 14 Days)

Title

Performance - Sensed R-wave Amplitude

Description

Summary statistics for sensed R-wave amplitude for each StealthTrac Lead model from insertion through removal

Time Frame

Lead removal (up to 14 Days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin C Burke, DO

Organizational Affiliation

AtaCor Medical, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Na Homolce Hospital

City

Prague

Country

Czechia

Facility Name

Christchurch Hospital

City

Christchurch

Country

New Zealand

Facility Name

Wellington Regional Hospital

City

Wellington

Country

New Zealand

Facility Name

Sanatorio Italiano

City

Asunción

Country

Paraguay

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

AtaCor Subcostal Temporary Extravascular Pacing III Study

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