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Subcostal Temporary Extravascular Pacing IV (STEP IV) Study (STEP IV)

Primary Purpose

Conduction Defect

Status

Completed

Phase

Not Applicable

Locations

Paraguay

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, Extravascular

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:

BMI ≥ 35 kg/m2
Septic shock
Severe anemia
Acute coronary syndrome within past 90 days
NYHA IV Functional Classification of heart failure within past 90 days
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 or unwillingness to provide 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
FEV1 < 1 liter
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

Sanatorio Italiano

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AtaCor EV Temporary Pacing Lead System

Arm Description

Subjects implanted with the AtaCor StealthTrac Lead Model AC-1013

Outcomes

Primary Outcome Measures

Freedom from ADEs

Freedom from Adverse Device Effects (ADEs)

Pacing Capture Threshold (V or mA)

Summary statistics for pacing capture threshold with the StealthTrac Lead from insertion through removal

Impedance (Ohms)

Summary statistics for impedance with the StealthTrac Lead from insertion through removal

Sensed R-Wave Amplitude (mV)

Summary statistics for sensed R-wave amplitude with the StealthTrac Lead from insertion through removal

Secondary Outcome Measures

Full Information

NCT ID

NCT05457673

First Posted

July 6, 2022

Last Updated

March 2, 2023

Sponsor

AtaCor Medical, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05457673

Brief Title

Subcostal Temporary Extravascular Pacing IV (STEP IV) Study

Acronym

STEP IV

Official Title

Subcostal Temporary Extravascular Pacing IV (STEP IV) Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

August 17, 2022 (Actual)

Primary Completion Date

September 22, 2022 (Actual)

Study Completion Date

October 20, 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

Data Monitoring Committee

5. Study Description

Brief Summary

The STEP IV Study is a prospective, single-center, non-randomized, single-arm study without concurrent or historical controls. The objective of the study is to generate safety and performance data of the latest AtaCor EV Temporary Pacing Lead System to support the development of a future pivotal study with an indication limited to a maximum of 7 days.

Detailed Description

The primary safety objective is freedom from Adverse Device Effects (ADE). The primary performance objective is summary statistics for pacing capture threshold, impedance, and sensed R-wave amplitude with the StealthTrac Lead from insertion through removal. One (1) Investigational Site in Paraguay will participate with up to 16 subjects enrolled in the study. Subjects indicated for a closed-chest cardiac invasive procedure will be eligible for participation. Subjects undergoing a qualifying index procedure will have a Model AC-1013 StealthTrac Lead inserted and evaluated over the follow-up period (up to 7 days post procedure). Study participation requires 2 to 7 days with the Study Lead inserted. Following Study Lead removal, a final follow-up will be performed 27-33 days after lead insertion to assess for any latent Adverse Events. Subjects remain enrolled until completion of the 30-Day Follow Up. The maximum duration for study participation is 33 days. The Study is expected to last up to 3 months after first enrollment: Enrollment and follow-up (1 month) and final report (2 months).

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, Extravascular

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

AtaCor EV Temporary Pacing Lead System

Arm Type

Experimental

Arm Description

Subjects implanted with the AtaCor StealthTrac Lead Model AC-1013

Intervention Type

Device

Intervention Name(s)

AtaCor StealthTrac Lead

Intervention Description

Subjects will receive the AtaCor StealthTrac Lead being evaluated in the study.

Primary Outcome Measure Information:

Title

Freedom from ADEs

Description

Freedom from Adverse Device Effects (ADEs)

Time Frame

Up to 7 days post-implant

Title

Pacing Capture Threshold (V or mA)

Description

Summary statistics for pacing capture threshold with the StealthTrac Lead from insertion through removal

Time Frame

Up to 7 days post-implant

Title

Impedance (Ohms)

Description

Summary statistics for impedance with the StealthTrac Lead from insertion through removal

Time Frame

Up to 7 days post-implant

Title

Sensed R-Wave Amplitude (mV)

Description

Summary statistics for sensed R-wave amplitude with the StealthTrac Lead from insertion through removal

Time Frame

Up to 7 days post-implant

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: BMI ≥ 35 kg/m2 Septic shock Severe anemia Acute coronary syndrome within past 90 days NYHA IV Functional Classification of heart failure within past 90 days 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 or unwillingness to provide 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 FEV1 < 1 liter 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

Sanatorio Italiano

City

Asunción

Country

Paraguay

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Subcostal Temporary Extravascular Pacing IV (STEP IV) Study

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