An interventional study of Subcostal Temporary Extracardiac Pacing Lead in Conduction Defect, sponsored by AtaCor Medical, Inc.. Completed at 1 site in Paraguay. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-03.
Sponsored by AtaCor Medical, Inc. · Not applicable, Interventional, and Basic science
Up to 15 subjects will be enrolled to evaluate initial safety and performance of the AtaCor Temporary Pacing System. Safety will be evaluated through analysis of all Adverse Events. Performance will be evaluated through (1) the incidence of successful StealthTrac Lead placement using the MACH I Delivery Tool, (2) electrical performance measurements, such as pacing capture thresholds, sensed R-wave amplitudes, pacing impedance and skeletal muscle stimulation at rest. Appropriate sensing and pacing capture will be ascertained from ECG Holter Monitor recordings during periods of in-hospital ambulation.
Enrolled Subjects will have both a market-released transvenous pacing lead and investigational StealthTrac Temporary Pacing Lead placed and evaluated. During the placement procedure, diagnostic echocardiograms will be performed to detect any new pericardial effusions. Once inserted, the StealthTrac Lead will be used to deliver high rate pacing (160 to 220 BPM) in clinically appropriate Subjects, to demonstrate suitability for use in transcatheter procedures that require brief periods of temporary pacing. Lead positions will be documented using fluoroscopic images before the Subject leaves the procedure room. On the following two days after the procedure, electrical performance will be evaluated in multiple postures and appropriate pacing and sensing will be confirmed during activity using ECG Holter monitor recordings. Subjects will also be asked patient-centric questions about their experience with the StealthTrac Lead throughout the study period. Evaluations will continue for a minimum of two (2) and a maximum of seven (7) days after the index procedure. Prior to StealthTrac Lead removal, an X-Ray will be taken to document the final lead position and diagnostic echocardiography will be performed to (1) detect any latent pericardial effusions and (2) assess differences in cardiac function with intrinsic conduction and while pacing. A final follow-up will be performed 25-30 days after removal to identify any latent adverse events before the Subject exits the study.
34 studies on the registry are indexed under Cardiac Conduction System Disease; 9 are open to participants now.
This study's enrollment of 12 is below the median of 35 across 16 interventional studies indexed under Cardiac Conduction System Disease.
Browse Cardiac Conduction System Disease studies →AtaCor Medical, Inc. is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Indicated for closed-chest cardiac invasive procedure with the potential for intra-procedural or post-procedural bradycardia and willing to be hospitalized for a minimum of 2 days post procedure.
Examples of such procedures include: transfemoral transcatheter aortic valve replacement (TAVR), balloon valvuloplasty, permanent pacemaker implantation and pacing lead extractions/revisions.
Exclusion Criteria:
All subjects will receive a subcostal temporary extracardiac pacing lead for a minimum of 48 hours in-hospital and undergo all protocol testing.
Device: 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.
Safety Outcome: Number of Subjects Experiencing an Adverse Device Effect
Safety will be evaluated through analysis of all Adverse Device Effects
Time frame: 30 days
Performance Outcome: Mean Pacing Capture Threshold (V)
Minimum current required to pacing the heart (in multiple postures)
Time frame: Up to 2 days post insertion
Performance Outcome: Mean Pacing Impedance (Ohms)
Impedance measured while pacing the heart (in multiple postures)
Time frame: Up to 2 days post insertion
Performance Outcome: Mean R-Wave Amplitude (mV)
R-Wave amplitudes measured while sensing the heart (in multiple postures)
Time frame: Up to 2 days post insertion
Performance Outcome: % of R-R Intervals With Appropriate Pacing and Sensing During Activity
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.
Time frame: Up to 2 days post insertion
Paced QRS Duration (ms)
QRS duration measured from 12-Lead ECG
Time frame: 1 day after insertion
Echocardiographic Assessment of Left Ventricular Stroke Volume During Pacing (mL)
Measures of cardiac function obtained from echocardiography
Time frame: 2 days after insertion
| Milestone | Subcostal Temporary Extracardiac Pacing Lead |
|---|---|
| Started | 12 |
| Completed | 11 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
Safety will be evaluated through analysis of all Adverse Device Effects
| Participants | Subcostal Temporary Extracardiac Pacing Lead |
|---|---|
| Safety Outcome: Number of Subjects Experiencing an Adverse Device Effect | 2 |
Minimum current required to pacing the heart (in multiple postures)
| Volts | Subcostal Temporary Extracardiac Pacing Lead |
|---|---|
| Day 0 (Procedure) | 4.1 ± 1.4 |
| Day 1 | 5.6 ± 2.7 |
| Day 2 | 7.0 ± 2.6 |
Impedance measured while pacing the heart (in multiple postures)
| Ohms | Subcostal Temporary Extracardiac Pacing Lead |
|---|---|
| Day 0 | 557 ± 176 |
| Day 1 | 320 ± 115 |
| Day 2 | 266 ± 60 |
R-Wave amplitudes measured while sensing the heart (in multiple postures)
| millivolts | Subcostal Temporary Extracardiac Pacing Lead |
|---|---|
| Day 0 | 4.9 ± 1.7 |
| Day 1 | 2.7 ± 1.3 |
| Day 2 | 2.6 ± 1.4 |
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.
| % of intervals | Subcostal Temporary Extracardiac Pacing Lead |
|---|---|
| Pacing Capture | 97.85 |
| Appropriate Sensing | 98.9 |
QRS duration measured from 12-Lead ECG
Results for this outcome have not been posted.
Measures of cardiac function obtained from echocardiography
Results for this outcome have not been posted.
Collected over 30 Days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subcostal Temporary Extracardiac Pacing Lead | 0/11 (0%) | 0/11 (0%) | 2/11 (18.2%) |
| Event | Subcostal Temporary Extracardiac Pacing Lead |
|---|---|
| Pain (Post-Operative)Surgical and medical procedures | 2/11 |
| Inability to PaceCardiac disorders | 1/11 |
| Age, Continuous(years) | Subcostal Temporary Extracardiac Pacing Lead |
|---|---|
| Mean | 67.7 ± 9.4 |
| Sex: Female, Male(Participants) | Subcostal Temporary Extracardiac Pacing Lead |
|---|---|
| Female | 4 |
| Male | 7 |
| Race/Ethnicity, Customized(Participants) | Subcostal Temporary Extracardiac Pacing Lead |
|---|---|
| Mestizo / Indigenous | 6 |
| White / Caucasian | 5 |
| Region of Enrollment(participants) | Subcostal Temporary Extracardiac Pacing Lead |
|---|---|
| Paraguay | 11 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cardiac Conduction System Disease→
AtaCor Medical, Inc.