AtaCor Subcostal Temporary Extravascular Pacing III Study

NCT04538287 | Completed

• 1 other identifier: DOC-10092
• Study Type: interventional
• Target: 33
• Locations: 3 countries
• Sites: 4

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.

Conditions

Conduction Defect

Keywords

Temporary Ventricular Pacing

Outcome Measures

Primary Outcomes (4)

• Safety - Freedom from Adverse Device Effects

  Freedom from Adverse Device Effects (ADE)

  Lead removal (up to 14 Days)

• Performance - Pacing Capture Threshold

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

  Lead removal (up to 14 Days)

• 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

  Lead removal (up to 14 Days)

• Performance - Sensed R-wave Amplitude

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

  Lead removal (up to 14 Days)

Study Arms (4)

AtaCor StealthTrac Lead Model AC-1010

ACTIVE COMPARATOR

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

Device: AtaCor StealthTrac Lead

AtaCor StealthTrac Lead Model AC-1020

ACTIVE COMPARATOR

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

Device: AtaCor StealthTrac Lead

AtaCor StealthTrac Lead Model AC-1021

ACTIVE COMPARATOR

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

Device: AtaCor StealthTrac Lead

AtaCor StealthTrac Lead Model AC-1012

ACTIVE COMPARATOR

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

Device: AtaCor StealthTrac Lead

Interventions

AtaCor StealthTrac Lead DEVICE

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

AtaCor StealthTrac Lead Model AC-1010; AtaCor StealthTrac Lead Model AC-1012; AtaCor StealthTrac Lead Model AC-1020; AtaCor StealthTrac Lead Model AC-1021

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:

• 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:

Sponsors & Collaborators

• AtaCor Medical, Inc.: lead

Study Sites (4)

Na Homolce Hospital

Prague, Czechia

Location

Christchurch Hospital

Christchurch, New Zealand

Location

Wellington Regional Hospital

Wellington, New Zealand

Location

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: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: September 4, 2020
• Study Start: October 3, 2020
• Primary Completion: January 25, 2022
• Study Completion: May 11, 2022
• Last Updated: July 7, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2); CZ (1); PA (1)