AtaCor Subcostal Temporary Extravascular Pacing III Study

NCT ID: NCT04538287

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-03
• Study Completion Date: 2022-05-11

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.

Detailed Description

Prior revisions of the study intended to evaluate multiple StealthTrac Leads (Models AC-1010, AC-1020, AC-2021 and AC-1030) to support the development of a future pivotal study. In the most recent revision of the study, an additional StealthTrac Lead (Model AC-1012) will be evaluated to support use in a larger pivotal study.

This study is a feasibility study serving dual purposes: 1) to generate developmental clinical data in support of a subsequent pivotal clinical study and marketing application for temporary pacing (in patients that retain the lead for a maximum of 7 days); and 2) to obtain early data for future research related to longer-term use (in patients that retain the lead for a maximum of 14 days).

Subjects undergoing a qualifying index procedure will have a Model AC-1012 StealthTrac Lead inserted, evaluated for a Maximum Lead Insertion Time prior to removal and a final post-removal follow-up 27-33 days after lead insertion. The following elements will change after the absence of AtaCor-related cardiac tamponade and no more than one (1) serious AtaCor-related pericardial effusion has been confirmed from the initial eight (8) experiences with the Model AC-1012 StealthTrac Lead, including insertion and removal procedures performed by multiple operators:

• Maximum Lead Insertion Time will change from 7 to 14 Days
• Follow-up will change from in-hospital follow-up only to allowing hospital discharge with the StealthTrac lead inserted, but capped and inactive after Day 2 provided in-person wound checks occur at least every 3 days
• Echocardiography requirements will transition from 3 distinct days to procedure day and removal day only.

Conditions

Conduction Defect

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

AtaCor StealthTrac Lead Model AC-1010

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

Group Type: ACTIVE_COMPARATOR

AtaCor StealthTrac Lead

Intervention Type: 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-1020

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

Group Type: ACTIVE_COMPARATOR

AtaCor StealthTrac Lead

Intervention Type: 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-1021

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

Group Type: ACTIVE_COMPARATOR

AtaCor StealthTrac Lead

Intervention Type: 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-1012

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

Group Type: ACTIVE_COMPARATOR

AtaCor StealthTrac Lead

Intervention Type: DEVICE

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

Interventions

AtaCor StealthTrac Lead

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. At least 18 years old

2. Indicated for closed-chest cardiac invasive procedure (e.g. transcatheter valve replacement, balloon valvuloplasty, permanent pacemaker implantation and pacing lead extractions/revisions)

Exclusion Criteria

1. NYHA IV functional class

2. Oxygen dependency

3. BMI ≥ 35 kg/m2

4. Circumstances that prevent data collection or follow-up (e.g., inability to perform a short walk with the Holter monitor)

5. Participation in any concurrent clinical study without prior written approval from the Sponsor

6. Inability to give an informed consent to participate in the Study

Known prior history for any of the following:

7. Median or partial sternotomy

8. Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium

9. Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)

10. Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments/conditions which may complicate the AtaCor EV Temporary Pacing Lead System insertion procedure

11. Pericardial disease, pericarditis and mediastinitis

12. Medical treatments, surgeries or conditions that increase the potential for pericardial adhesions

13. Severe to very severe airflow limitation, defined as FEV1/FVC <0.7 AND FEV1 < 50% predicted

14. Symptomatic COPD exacerbation associated with either:

1. Modified MRC Dyspnea Scale Grade ≥2, OR

2. CAT Assessment

15. Surgically corrected congenital heart disease (not including catheter-based procedures)

16. Allergies to the device materials such as stainless steel, titanium, platinum, iridium, polyethylene, polyurethane, polycarbonate and silicone

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AtaCor Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin C Burke, DO

Role: PRINCIPAL_INVESTIGATOR

AtaCor Medical, Inc.

Locations

Na Homolce Hospital

Prague, , Czechia

Christchurch Hospital

Christchurch, , New Zealand

Wellington Regional Hospital

Wellington, , New Zealand

Sanatorio Italiano

Asunción, , Paraguay

Countries

Czechia; New Zealand; Paraguay

Other Identifiers

DOC-10092

Identifier Type: -

Identifier Source: org_study_id