Subcostal Temporary Extravascular Pacing IV (STEP IV) Study

NCT05457673 | Completed

• 1 other identifier: DOC-10200
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Conduction Defect

Keywords

Temporary Ventricular Pacing; Extravascular

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 Lead DEVICE

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

AtaCor EV Temporary Pacing Lead System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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)

You may not qualify if:

• 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

Sponsors & Collaborators

• AtaCor Medical, Inc.: lead

Study Sites (1)

Sanatorio Italiano

Asunción, Paraguay

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin C Burke, DO

  AtaCor Medical, Inc.

  PRINCIPAL INVESTIGATOR

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
• Primary Completion: September 22, 2022
• Study Completion: October 20, 2022
• Last Updated: March 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)