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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04538287




Registration number
NCT04538287
Ethics application status
Date submitted
25/08/2020
Date registered
4/09/2020

Titles & IDs
Public title
AtaCor Subcostal Temporary Extravascular Pacing III Study
Scientific title
AtaCor Subcostal Temporary Extravascular Pacing III Study
Secondary ID [1] 0 0
DOC-10092
Universal Trial Number (UTN)
Trial acronym
STEP III
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Conduction Defect 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - AtaCor StealthTrac Lead

Active comparator: 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.

Active comparator: 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.

Active comparator: 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.

Active comparator: 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.


Treatment: Devices: AtaCor StealthTrac Lead
Subjects are assigned non-randomly to receive one of the four AtaCor StealthTrac leads being evaluated in the study.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety - Freedom from Adverse Device Effects
Assessment method [1] 0 0
Freedom from Adverse Device Effects (ADE)
Timepoint [1] 0 0
Lead removal (up to 14 Days)
Primary outcome [2] 0 0
Performance - Pacing Capture Threshold
Assessment method [2] 0 0
Summary statistics for pacing capture threshold for each StealthTrac Lead model from insertion through removal
Timepoint [2] 0 0
Lead removal (up to 14 Days)
Primary outcome [3] 0 0
Performance - Pacing Impedance
Assessment method [3] 0 0
Summary statistics for pacing impedance for each StealthTrac Lead model from insertion through removal for each StealthTrac Lead model from insertion through removal
Timepoint [3] 0 0
Lead removal (up to 14 Days)
Primary outcome [4] 0 0
Performance - Sensed R-wave Amplitude
Assessment method [4] 0 0
Summary statistics for sensed R-wave amplitude for each StealthTrac Lead model from insertion through removal
Timepoint [4] 0 0
Lead removal (up to 14 Days)

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/05/2022
Sample size
Target
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Czechia
State/province [1] 0 0
Prague
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Wellington
Country [4] 0 0
Paraguay
State/province [4] 0 0
Asunción

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AtaCor Medical, Inc.
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Martin C Burke, DO
Address 0 0
AtaCor Medical, Inc.
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04538287