Conduction Defect
Conditions
Keywords
Temporary, Ventricular, Pacing
Brief summary
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.
Detailed description
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.
Interventions
DEVICESubcostal 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.
Sponsors
AtaCor Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Physically and mentally capable of providing informed consent. 3. At least 18 years of age or of legal age to provide consent as required by local and national requirements.
Exclusion criteria
1. Contraindicated or clinically unsuitable for transvenous lead placement; 2. Implanted with an implantable cardioverter defibrillator (ICD) or transvenous defibrillation lead at the time of enrollment; 3. History of a prior sternotomy (median or partial); 4. History of prior surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium; 5. History of significant anatomic derangement of the thorax (e.g., pectus excavatum), prior chest radiation therapy or other reasons which may cause pericardial adhesions or complicate the AtaCor Temporary Pacing System insertion procedure; 6. History of pericardial disease, pericarditis or mediastinitis; 7. History of chronic obstructive pulmonary disease (COPD); 8. NYHA functional classification IV at the time of enrollment; 9. History of congenital heart disease; 10. Patients with circumstances that prevent data collection or follow-up, including conditions that prevent ambulation and testing in multiple postures; 11. BMI ≥ 35 kg/m2; 12. History of allergies to any study device components; 13. Pregnant or lactating (current or anticipated during study follow up); and 14. Participation in any concurrent study without prior, written approval from the Sponsor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance Outcome: Mean Pacing Capture Threshold (V) | Up to 2 days post insertion | Minimum current required to pacing the heart (in multiple postures) |
| Performance Outcome: Mean R-Wave Amplitude (mV) | Up to 2 days post insertion | R-Wave amplitudes measured while sensing the heart (in multiple postures) |
| Performance Outcome: % of R-R Intervals With Appropriate Pacing and Sensing During Activity | Up to 2 days post insertion | 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. |
| Safety Outcome: Number of Subjects Experiencing an Adverse Device Effect | 30 days | Safety will be evaluated through analysis of all Adverse Device Effects |
| Performance Outcome: Mean Pacing Impedance (Ohms) | Up to 2 days post insertion | Impedance measured while pacing the heart (in multiple postures) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Echocardiographic Assessment of Left Ventricular Stroke Volume During Pacing (mL) | 2 days after insertion | Measures of cardiac function obtained from echocardiography |
| Paced QRS Duration (ms) | 1 day after insertion | QRS duration measured from 12-Lead ECG |
Countries
Paraguay
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Subcostal Temporary Extracardiac Pacing Lead |
|---|---|
| Age, Continuous | 67.7 years STANDARD_DEVIATION 9.4 |
| Race/Ethnicity, Customized Mestizo / Indigenous | 6 Participants |
| Race/Ethnicity, Customized White / Caucasian | 5 Participants |
| Region of Enrollment Paraguay | 11 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 2 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
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
Population: One suspected lead dislodgement prevented measurements in all 11 subjects on Day 1 and Day 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subcostal Temporary Extracardiac Pacing Lead | Performance Outcome: Mean Pacing Capture Threshold (V) | Day 0 (Procedure) | 4.1 Volts | Standard Deviation 1.4 |
| Subcostal Temporary Extracardiac Pacing Lead | Performance Outcome: Mean Pacing Capture Threshold (V) | Day 1 | 5.6 Volts | Standard Deviation 2.7 |
| Subcostal Temporary Extracardiac Pacing Lead | Performance Outcome: Mean Pacing Capture Threshold (V) | Day 2 | 7.0 Volts | Standard Deviation 2.6 |
Primary
Performance Outcome: Mean Pacing Impedance (Ohms)
Impedance measured while pacing the heart (in multiple postures)
Time frame: Up to 2 days post insertion
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subcostal Temporary Extracardiac Pacing Lead | Performance Outcome: Mean Pacing Impedance (Ohms) | Day 0 | 557 Ohms | Standard Deviation 176 |
| Subcostal Temporary Extracardiac Pacing Lead | Performance Outcome: Mean Pacing Impedance (Ohms) | Day 1 | 320 Ohms | Standard Deviation 115 |
| Subcostal Temporary Extracardiac Pacing Lead | Performance Outcome: Mean Pacing Impedance (Ohms) | Day 2 | 266 Ohms | Standard Deviation 60 |
Primary
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
Population: Only 4 of 11 subjects had an intrinsic rhythm for measurement of R waves.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subcostal Temporary Extracardiac Pacing Lead | Performance Outcome: Mean R-Wave Amplitude (mV) | Day 0 | 4.9 millivolts | Standard Deviation 1.7 |
| Subcostal Temporary Extracardiac Pacing Lead | Performance Outcome: Mean R-Wave Amplitude (mV) | Day 1 | 2.7 millivolts | Standard Deviation 1.3 |
| Subcostal Temporary Extracardiac Pacing Lead | Performance Outcome: Mean R-Wave Amplitude (mV) | Day 2 | 2.6 millivolts | Standard Deviation 1.4 |
Primary
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
Population: All subjects with a StealthTrac Lead
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcostal Temporary Extracardiac Pacing Lead | Performance Outcome: % of R-R Intervals With Appropriate Pacing and Sensing During Activity | Pacing Capture | 97.85 % of intervals |
| Subcostal Temporary Extracardiac Pacing Lead | Performance Outcome: % of R-R Intervals With Appropriate Pacing and Sensing During Activity | Appropriate Sensing | 98.9 % of intervals |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subcostal Temporary Extracardiac Pacing Lead | Safety Outcome: Number of Subjects Experiencing an Adverse Device Effect | 2 Participants |
Other Pre-specified
Echocardiographic Assessment of Left Ventricular Stroke Volume During Pacing (mL)
Measures of cardiac function obtained from echocardiography
Time frame: 2 days after insertion
Other Pre-specified
Paced QRS Duration (ms)
QRS duration measured from 12-Lead ECG
Time frame: 1 day after insertion