NCT04538287|Completed
AtaCor Subcostal Temporary Extravascular Pacing III Study
STEP III
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STEP III
Sponsor study identifier
interventional
33
3 countries
4
Study Start
October 3, 2020
Actual (reported)Primary Completion
January 25, 2022
Actual (reported)Study Completion
May 11, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 11, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 25, 2020
Actual (reported)September 4, 2020
Actual (reported)October 3, 2020
Actual (reported)January 25, 2022
Actual (reported)May 11, 2022
Actual (reported)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)
Subjects inserted with the AtaCor StealthTrac Lead Model AC-1010. This was the first model evaluated in the study.
Subjects inserted with the AtaCor StealthTrac Lead Model AC-1020. This was the second model evaluated in the study.
Subjects inserted with the AtaCor StealthTrac Lead Model AC-1021. This was the third model evaluated in the study.
Subjects are assigned non-randomly to receive one of the four AtaCor StealthTrac leads being evaluated in the study.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Na Homolce Hospital
Prague, Czechia
Christchurch Hospital
Christchurch, New Zealand
Wellington Regional Hospital
Wellington, New Zealand
Sanatorio Italiano
Asunción, Paraguay
Martin C Burke, DO
AtaCor Medical, Inc.
33 participants (actual enrollment reported by the registry).
First Submitted
August 25, 2020
First Posted
September 4, 2020
Study Start
October 3, 2020
Actual (reported)Subcostal Temporary Extracardiac Pacing Study
Subjects inserted with the AtaCor StealthTrac Lead Model AC-1012. This is the fourth model currently being evaluated in the study.
Contact the study team to confirm eligibility.
Primary Completion
January 25, 2022
Actual (reported)Study Completion
May 11, 2022
Actual (reported)Last Updated
July 7, 2022
Record last verified: 2022-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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