search
Back to results

Subcostal Temporary Extravascular Pacing V Study (STEP V)

Primary Purpose

Conduction Defect

Status
Completed
Phase
Not Applicable
Locations
Paraguay
Study Type
Interventional
Intervention
AtaCor StealthTrac Lead
Sponsored by
AtaCor Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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 Subjects indicated for closed-chest cardiac invasive procedure, including: Transarterial transcatheter aortic valve implantation (TAVI) Transarterial balloon aortic valvuloplasty (BAV) Cardiovascular implantable electronic device (CIED) pulse generator replacement Cardiovascular implantable electronic device (CIED) lead extraction or revision Exclusion criteria BMI ≥ 35 kg/m2 Septic shock Severe anemia Patients on dual antiplatelet therapy or anti-coagulation that cannot be stopped for the procedure 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 Acute coronary syndrome within past 90 days NYHA Functional Classification IV within past 90 days 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 Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium, including adhesions Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis) Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments which may complicate the AtaCor EV Temporary Pacing Lead System insertion procedure Any 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

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-101400

Outcomes

Primary Outcome Measures

Freedom from ADEs
Freedom from Adverse Device Effects (ADE)
Pacing Capture Threshold (mA or V)
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

First Posted
November 22, 2022
Last Updated
March 2, 2023
Sponsor
AtaCor Medical, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05633394
Brief Title
Subcostal Temporary Extravascular Pacing V Study
Acronym
STEP V
Official Title
Subcostal Temporary Extravascular Pacing V (STEP V) Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 23, 2023 (Actual)
Primary Completion Date
January 26, 2023 (Actual)
Study Completion Date
February 23, 2023 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The STEP V Study is a prospective, multicenter, acute (in-hospital), single-arm feasibility study. The objective of the study is to evaluate the early safety and performance of the latest AtaCor EV Temporary Pacing Lead System over a two-day use period with Subjects restricted to bedrest. Lead performance will also be evaluated without bedrest restrictions in the limited period shortly before lead removal on the last follow-up day.
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. Up to three (3) Investigational Sites will participate with up to 16 subjects enrolled in the study. Subjects indicated for closed-chest cardiac invasive procedures will be eligible for participation. Subjects undergoing a qualifying index procedure will have a Model AC-101400 StealthTrac Lead inserted and evaluated over the follow-up period. Subject participation is expected to be 2 days with the Study Lead inserted, plus 30 days post lead removal. A 30 day (+/-3 days) post-removal follow-up will also be performed to document 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
10 (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-101400
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 (ADE)
Time Frame
Up to 2 days post-insertion
Title
Pacing Capture Threshold (mA or V)
Description
Summary statistics for pacing capture threshold with the StealthTrac Lead from insertion through removal
Time Frame
Up to 2 days post-insertion
Title
Impedance (Ohms)
Description
Summary statistics for impedance with the StealthTrac Lead from insertion through removal
Time Frame
Up to 2 days post-insertion
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 2 days post-insertion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria At least 18 years old Subjects indicated for closed-chest cardiac invasive procedure, including: Transarterial transcatheter aortic valve implantation (TAVI) Transarterial balloon aortic valvuloplasty (BAV) Cardiovascular implantable electronic device (CIED) pulse generator replacement Cardiovascular implantable electronic device (CIED) lead extraction or revision Exclusion criteria BMI ≥ 35 kg/m2 Septic shock Severe anemia Patients on dual antiplatelet therapy or anti-coagulation that cannot be stopped for the procedure 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 Acute coronary syndrome within past 90 days NYHA Functional Classification IV within past 90 days 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 Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium, including adhesions Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis) Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments which may complicate the AtaCor EV Temporary Pacing Lead System insertion procedure Any 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
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

Learn more about this trial

Subcostal Temporary Extravascular Pacing V Study

We'll reach out to this number within 24 hrs