Trials Sponsors Conditions Drugs Pricing

Conditions

Conduction Defect

Keywords

Temporary Ventricular PacingExtravascular

Outcome Measures

Primary Outcomes (4)

Freedom from ADEs
Freedom from Adverse Device Effects (ADEs)
Up to 7 days post-implant
Pacing Capture Threshold (V or mA)
Summary statistics for pacing capture threshold with the StealthTrac Lead from insertion through removal
Up to 7 days post-implant
Impedance (Ohms)
Summary statistics for impedance with the StealthTrac Lead from insertion through removal
Up to 7 days post-implant
Sensed R-Wave Amplitude (mV)
Summary statistics for sensed R-wave amplitude with the StealthTrac Lead from insertion through removal
Up to 7 days post-implant

Study Arms (1)

AtaCor EV Temporary Pacing Lead System

EXPERIMENTAL

Subjects implanted with the AtaCor StealthTrac Lead Model AC-1013

Device: AtaCor StealthTrac Lead

Interventions

AtaCor StealthTrac LeadDevice

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

AtaCor EV Temporary Pacing Lead System

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)

Sponsors & Collaborators

AtaCor Medical, Inc.
Industrylead

Study Sites (1)

Sanatorio Italiano

Asunción, Paraguay

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Martin C Burke, DO
AtaCor Medical, Inc.
PRINCIPAL INVESTIGATOR

Enrollment

12 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: BASIC SCIENCE
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 6, 2022

First Posted

July 14, 2022

Study Start

August 17, 2022

Actual (reported)

Subcostal Temporary Extravascular Pacing IV (STEP IV) Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Study Arms (1)

AtaCor EV Temporary Pacing Lead System

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Study Arms (1)

AtaCor EV Temporary Pacing Lead System

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations