Trial Outcomes & Findings for Subcostal Temporary Extracardiac Pacing Study (NCT NCT04096365)
NCT ID: NCT04096365
Last Updated: 2021-02-03
Results Overview
Safety will be evaluated through analysis of all Adverse Device Effects
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
30 days
Results posted on
2021-02-03
Participant Flow
Eleven (11) of the 12 enrolled subjects underwent a StealthTrac Lead insertion procedure. One (1) subject experienced an adverse clinical event, unrelated to the StealthTrac Lead, that precluded insertion of the StealthTrac Lead and was subsequently withdrawn from the study.
Participant milestones
| Measure |
Subcostal Temporary Extracardiac Pacing Lead
All subjects will receive a subcostal temporary extracardiac pacing lead for a minimum of 48 hours in-hospital and undergo all protocol testing.
Subcostal Temporary Extracardiac Pacing Lead: The StealthTrac Lead is designed to facilitate extracardiac temporary ventricular pacing and sensing. The distal end of the StealthTrac Lead is designed to reside within the connective tissue of the anterior mediastinum outside the pericardium. The StealthTrac Lead is delivered using the MACH I Delivery Tool, which is designed to facilitate insertion of the StealthTrac Lead through a small skin incision parallel to the sternum, without the need for fluoroscopic guidance.
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Overall Study
STARTED
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12
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Overall Study
COMPLETED
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11
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Subcostal Temporary Extracardiac Pacing Lead
All subjects will receive a subcostal temporary extracardiac pacing lead for a minimum of 48 hours in-hospital and undergo all protocol testing.
Subcostal Temporary Extracardiac Pacing Lead: The StealthTrac Lead is designed to facilitate extracardiac temporary ventricular pacing and sensing. The distal end of the StealthTrac Lead is designed to reside within the connective tissue of the anterior mediastinum outside the pericardium. The StealthTrac Lead is delivered using the MACH I Delivery Tool, which is designed to facilitate insertion of the StealthTrac Lead through a small skin incision parallel to the sternum, without the need for fluoroscopic guidance.
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Overall Study
Adverse Event
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1
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Baseline Characteristics
Subcostal Temporary Extracardiac Pacing Study
Baseline characteristics by cohort
| Measure |
Subcostal Temporary Extracardiac Pacing Lead
n=11 Participants
All subjects will receive a subcostal temporary extracardiac pacing lead for a minimum of 48 hours in-hospital and undergo all protocol testing.
Subcostal Temporary Extracardiac Pacing Lead: The StealthTrac Lead is designed to facilitate extracardiac temporary ventricular pacing and sensing. The distal end of the StealthTrac Lead is designed to reside within the connective tissue of the anterior mediastinum outside the pericardium. The StealthTrac Lead is delivered using the MACH I Delivery Tool, which is designed to facilitate insertion of the StealthTrac Lead through a small skin incision parallel to the sternum, without the need for fluoroscopic guidance.
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Age, Continuous
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67.7 years
STANDARD_DEVIATION 9.4 • n=99 Participants
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Sex: Female, Male
Female
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4 Participants
n=99 Participants
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Sex: Female, Male
Male
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7 Participants
n=99 Participants
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Race/Ethnicity, Customized
Mestizo / Indigenous
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6 Participants
n=99 Participants
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Race/Ethnicity, Customized
White / Caucasian
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5 Participants
n=99 Participants
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Region of Enrollment
Paraguay
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11 participants
n=99 Participants
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PRIMARY outcome
Timeframe: 30 daysSafety will be evaluated through analysis of all Adverse Device Effects
Outcome measures
| Measure |
Subcostal Temporary Extracardiac Pacing Lead
n=11 Participants
All subjects will receive a subcostal temporary extracardiac pacing lead for a minimum of 48 hours in-hospital and undergo all protocol testing.
Subcostal Temporary Extracardiac Pacing Lead: The StealthTrac Lead is designed to facilitate extracardiac temporary ventricular pacing and sensing. The distal end of the StealthTrac Lead is designed to reside within the connective tissue of the anterior mediastinum outside the pericardium. The StealthTrac Lead is delivered using the MACH I Delivery Tool, which is designed to facilitate insertion of the StealthTrac Lead through a small skin incision parallel to the sternum, without the need for fluoroscopic guidance.
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Safety Outcome: Number of Subjects Experiencing an Adverse Device Effect
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2 Participants
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PRIMARY outcome
Timeframe: Up to 2 days post insertionPopulation: One suspected lead dislodgement prevented measurements in all 11 subjects on Day 1 and Day 2.
Minimum current required to pacing the heart (in multiple postures)
Outcome measures
| Measure |
Subcostal Temporary Extracardiac Pacing Lead
n=11 Participants
All subjects will receive a subcostal temporary extracardiac pacing lead for a minimum of 48 hours in-hospital and undergo all protocol testing.
Subcostal Temporary Extracardiac Pacing Lead: The StealthTrac Lead is designed to facilitate extracardiac temporary ventricular pacing and sensing. The distal end of the StealthTrac Lead is designed to reside within the connective tissue of the anterior mediastinum outside the pericardium. The StealthTrac Lead is delivered using the MACH I Delivery Tool, which is designed to facilitate insertion of the StealthTrac Lead through a small skin incision parallel to the sternum, without the need for fluoroscopic guidance.
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Performance Outcome: Mean Pacing Capture Threshold (V)
Day 0 (Procedure)
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4.1 Volts
Standard Deviation 1.4
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Performance Outcome: Mean Pacing Capture Threshold (V)
Day 1
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5.6 Volts
Standard Deviation 2.7
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Performance Outcome: Mean Pacing Capture Threshold (V)
Day 2
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7.0 Volts
Standard Deviation 2.6
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PRIMARY outcome
Timeframe: Up to 2 days post insertionPopulation: All eleven (11) Subjects contribute data on Day 0. On Day 1 and Day 2, nine (9) Subjects contribute data and two (2) Subjects do not due to a suspected lead dislodgement and one measurement out of range.
Impedance measured while pacing the heart (in multiple postures)
Outcome measures
| Measure |
Subcostal Temporary Extracardiac Pacing Lead
n=11 Participants
All subjects will receive a subcostal temporary extracardiac pacing lead for a minimum of 48 hours in-hospital and undergo all protocol testing.
Subcostal Temporary Extracardiac Pacing Lead: The StealthTrac Lead is designed to facilitate extracardiac temporary ventricular pacing and sensing. The distal end of the StealthTrac Lead is designed to reside within the connective tissue of the anterior mediastinum outside the pericardium. The StealthTrac Lead is delivered using the MACH I Delivery Tool, which is designed to facilitate insertion of the StealthTrac Lead through a small skin incision parallel to the sternum, without the need for fluoroscopic guidance.
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Performance Outcome: Mean Pacing Impedance (Ohms)
Day 1
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320 Ohms
Standard Deviation 115
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Performance Outcome: Mean Pacing Impedance (Ohms)
Day 2
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266 Ohms
Standard Deviation 60
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Performance Outcome: Mean Pacing Impedance (Ohms)
Day 0
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557 Ohms
Standard Deviation 176
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PRIMARY outcome
Timeframe: Up to 2 days post insertionPopulation: Only 4 of 11 subjects had an intrinsic rhythm for measurement of R waves.
R-Wave amplitudes measured while sensing the heart (in multiple postures)
Outcome measures
| Measure |
Subcostal Temporary Extracardiac Pacing Lead
n=4 Participants
All subjects will receive a subcostal temporary extracardiac pacing lead for a minimum of 48 hours in-hospital and undergo all protocol testing.
Subcostal Temporary Extracardiac Pacing Lead: The StealthTrac Lead is designed to facilitate extracardiac temporary ventricular pacing and sensing. The distal end of the StealthTrac Lead is designed to reside within the connective tissue of the anterior mediastinum outside the pericardium. The StealthTrac Lead is delivered using the MACH I Delivery Tool, which is designed to facilitate insertion of the StealthTrac Lead through a small skin incision parallel to the sternum, without the need for fluoroscopic guidance.
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Performance Outcome: Mean R-Wave Amplitude (mV)
Day 0
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4.9 millivolts
Standard Deviation 1.7
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Performance Outcome: Mean R-Wave Amplitude (mV)
Day 1
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2.7 millivolts
Standard Deviation 1.3
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Performance Outcome: Mean R-Wave Amplitude (mV)
Day 2
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2.6 millivolts
Standard Deviation 1.4
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PRIMARY outcome
Timeframe: Up to 2 days post insertionPopulation: All subjects with a StealthTrac Lead
ECG Holter Recordings obtained during periods of rest and in-hospital activity. The % of R-R intervals with appropriate pacing is calculated as the number of paced intervals that demonstrate pacing capture / the total number of pacing intervals. The % of R-R intervals with appropriate sensing is calculated as the number of intervals where pacing is appropriately delivered or inhibited (depending on the programmed settings of the pacemaker) / the total number of R-R intervals. The outcomes are presented a % of intervals and not an average of the percentages observed across patients.
Outcome measures
| Measure |
Subcostal Temporary Extracardiac Pacing Lead
n=11 Participants
All subjects will receive a subcostal temporary extracardiac pacing lead for a minimum of 48 hours in-hospital and undergo all protocol testing.
Subcostal Temporary Extracardiac Pacing Lead: The StealthTrac Lead is designed to facilitate extracardiac temporary ventricular pacing and sensing. The distal end of the StealthTrac Lead is designed to reside within the connective tissue of the anterior mediastinum outside the pericardium. The StealthTrac Lead is delivered using the MACH I Delivery Tool, which is designed to facilitate insertion of the StealthTrac Lead through a small skin incision parallel to the sternum, without the need for fluoroscopic guidance.
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Performance Outcome: % of R-R Intervals With Appropriate Pacing and Sensing During Activity
Pacing Capture
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97.85 % of intervals
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Performance Outcome: % of R-R Intervals With Appropriate Pacing and Sensing During Activity
Appropriate Sensing
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98.9 % of intervals
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OTHER_PRE_SPECIFIED outcome
Timeframe: 1 day after insertionQRS duration measured from 12-Lead ECG
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 days after insertionMeasures of cardiac function obtained from echocardiography
Outcome measures
Outcome data not reported
Adverse Events
Subcostal Temporary Extracardiac Pacing Lead
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Subcostal Temporary Extracardiac Pacing Lead
n=11 participants at risk
All subjects will receive a subcostal temporary extracardiac pacing lead for a minimum of 48 hours in-hospital and undergo all protocol testing.
Subcostal Temporary Extracardiac Pacing Lead: The StealthTrac Lead is designed to facilitate extracardiac temporary ventricular pacing and sensing. The distal end of the StealthTrac Lead is designed to reside within the connective tissue of the anterior mediastinum outside the pericardium. The StealthTrac Lead is delivered using the MACH I Delivery Tool, which is designed to facilitate insertion of the StealthTrac Lead through a small skin incision parallel to the sternum, without the need for fluoroscopic guidance.
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Surgical and medical procedures
Pain (Post-Operative)
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18.2%
2/11 • Number of events 2 • 30 Days
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Cardiac disorders
Inability to Pace
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9.1%
1/11 • Number of events 1 • 30 Days
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Additional Information
Alan Marcovecchio, Vice President, Clinical Affairs
AtaCor Medical, Inc.
Phone: 949 391 2252
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator must obtain prior written consent of Sponsor before publishing.
- Publication restrictions are in place
Restriction type: OTHER