Trial Outcomes & Findings for RF Surgical Sponge-Detecting System on the Function of Pacemakers and Implantable Cardioverter Defibrillators (NCT NCT02111980)
NCT ID: NCT02111980
Last Updated: 2019-12-24
Results Overview
The Pacing Mode on the CIED was measured prior to RF scanning (with sponge) and after the scanning (after sponge removal) in order to evaluate if any significant changes in the pacing mode setting resulted. The following CIED modes were evaluated: DDD (dual chamber pacing, sensing, triggered and inhibited mode), VVI (ventricular pacing, sensing, and inhibited mode), DDI (dual pacing, sensing, and inhibited mode), AAI (atrial pacing, sensing, and inhibited mode). The number of patients' device mode switched between these settings was tabulated and is shown in the below table. Multiple post-scan assessments were not made.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Baseline and 15 minutes
Results posted on
2019-12-24
Participant Flow
Patients that required a pacemaker/ICD generator change or device implant were approached for participation in this study in both the Sulpizio Cardiovascular Center Clinic and Pre-procedural Unit. Patients undergoing PTE Surgery were also approached in these settings.
Participant milestones
| Measure |
RF Assure Scanning
The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.
RF Assure Scanning: CIED and temporary pacemaker patients were scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was be conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology. Vitals were monitored and recorded before, during, and after scanning.
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|---|---|
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Overall Study
STARTED
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50
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Overall Study
COMPLETED
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50
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.
Baseline characteristics by cohort
| Measure |
RF Assure Scanning
n=50 Participants
Cardiac implantable electronic device (CIED) (implantable cardiac defibrillator (ICD) and permanent pacemakers (PPM)) and temporary pacemaker patients (during pulmonary thromboendartectomy (PTE) surgery) were scanned with the Radiofrequency (RF) surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology.
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|---|---|
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Age, Continuous
Pacemaker
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74.5 years
STANDARD_DEVIATION 17 • n=20 Participants • 50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.
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Age, Continuous
ICD
|
64 years
STANDARD_DEVIATION 17.4 • n=20 Participants • 50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.
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Age, Continuous
PTE
|
54.9 years
STANDARD_DEVIATION 13.1 • n=10 Participants • 50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.
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Sex: Female, Male
Female
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16 Participants
n=50 Participants
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Sex: Female, Male
Male
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34 Participants
n=50 Participants
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Region of Enrollment
United States
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50 participants
n=50 Participants
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Body Mass Index (BMI)
Pacemaker
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26.3 kg/m^2
STANDARD_DEVIATION 3.6 • n=20 Participants • 50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.
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Body Mass Index (BMI)
ICD
|
29.8 kg/m^2
STANDARD_DEVIATION 6.1 • n=20 Participants • 50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.
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Body Mass Index (BMI)
PTE
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30.8 kg/m^2
STANDARD_DEVIATION 3.9 • n=10 Participants • 50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.
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History of Coronary Artery Disease (CAD)
Pacemaker
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6 participants
n=20 Participants • 50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.
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History of Coronary Artery Disease (CAD)
ICD
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6 participants
n=20 Participants • 50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.
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History of Coronary Artery Disease (CAD)
PTE
|
1 participants
n=10 Participants • 50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.
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History of Atrial Fibrillation (AF)
Pacemaker
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14 participants
n=20 Participants • 50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.
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History of Atrial Fibrillation (AF)
ICD
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5 participants
n=20 Participants • 50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.
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History of Atrial Fibrillation (AF)
PTE
|
2 participants
n=10 Participants • 50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.
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History of Diabetes Mellitus (DM)
Pacemaker
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3 participants
n=20 Participants • 50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.
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History of Diabetes Mellitus (DM)
ICD
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6 participants
n=20 Participants • 50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.
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History of Diabetes Mellitus (DM)
PTE
|
3 participants
n=10 Participants • 50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.
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History of Hypertension (HTN)
Pacemaker
|
15 participants
n=20 Participants • 50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.
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History of Hypertension (HTN)
ICD
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10 participants
n=20 Participants • 50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.
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History of Hypertension (HTN)
PTE
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5 participants
n=10 Participants • 50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.
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Measured Ejection Fraction (EF) (%)
Pacemaker
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56.2 percentage
STANDARD_DEVIATION 17 • n=20 Participants • 50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.
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Measured Ejection Fraction (EF) (%)
ICD
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37 percentage
STANDARD_DEVIATION 17 • n=20 Participants • 50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.
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Measured Ejection Fraction (EF) (%)
PTE
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67.6 percentage
STANDARD_DEVIATION 10 • n=10 Participants • 50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.
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PRIMARY outcome
Timeframe: Baseline and 15 minutesPopulation: The PTE participants were not included in this analysis because temporary devices do not have capabilities for interrogation (ie: recording pacing mode changes).
The Pacing Mode on the CIED was measured prior to RF scanning (with sponge) and after the scanning (after sponge removal) in order to evaluate if any significant changes in the pacing mode setting resulted. The following CIED modes were evaluated: DDD (dual chamber pacing, sensing, triggered and inhibited mode), VVI (ventricular pacing, sensing, and inhibited mode), DDI (dual pacing, sensing, and inhibited mode), AAI (atrial pacing, sensing, and inhibited mode). The number of patients' device mode switched between these settings was tabulated and is shown in the below table. Multiple post-scan assessments were not made.
Outcome measures
| Measure |
Pre-Scan Measures for PPM/ICDs Scanned With RF Assure
n=40 Participants
The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.
RF Assure Scanning: CIED and temporary pacemaker patients were scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was be conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology. Vitals were monitored and recorded before, during, and after scanning.
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Post-Scan Measures for PPM/ICDs Scanned With RF Assure
n=40 Participants
The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.
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Pacing Mode Changes Between Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure
Pacing Mode - DDD
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29 participants
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29 participants
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Pacing Mode Changes Between Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure
Pacing Mode - VVI
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8 participants
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8 participants
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Pacing Mode Changes Between Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure
Pacing Mode - DDI
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2 participants
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2 participants
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Pacing Mode Changes Between Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure
Pacing Mode - AAI
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1 participants
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1 participants
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PRIMARY outcome
Timeframe: Baseline and 15 minutesPopulation: The PTE participants were not included in this analysis because temporary devices do not have capabilities for interrogation (ie: recording pacing polarity changes).
The patient's pacing polarity was measured prior to scanning with sponge and after scanning with sponge via device interrogation. The following pacing polarity measurements were evaluated: right atrium/right ventricle (RA/RV) bipolar polarity, left ventricle (LV) bipolar polarity, and left ventricle (LV) unipolar polarity. Note that not all study patients had LV leads implanted. Multiple post-scan assessments were not made.
Outcome measures
| Measure |
Pre-Scan Measures for PPM/ICDs Scanned With RF Assure
n=40 Participants
The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.
RF Assure Scanning: CIED and temporary pacemaker patients were scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was be conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology. Vitals were monitored and recorded before, during, and after scanning.
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Post-Scan Measures for PPM/ICDs Scanned With RF Assure
n=40 Participants
The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.
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Pacing Polarity Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure
RA/RV (bipolar)
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40 participants
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40 participants
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Pacing Polarity Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure
LV (bipolar)
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5 participants
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5 participants
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Pacing Polarity Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure
LV (unipolar)
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3 participants
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3 participants
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PRIMARY outcome
Timeframe: Baseline and 15 minutesPopulation: The PTE temporary pacing participants were not included in this analysis because temporary devices do not have capabilities for interrogation (ie: recording base rate measurement changes).
The base rate on patients' devices was measured before scanning with sponge and after RF scanning with sponge. The median was determined and is presented below with standard deviation for both times. Multiple post-scan assessments were not made.
Outcome measures
| Measure |
Pre-Scan Measures for PPM/ICDs Scanned With RF Assure
n=40 Participants
The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.
RF Assure Scanning: CIED and temporary pacemaker patients were scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was be conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology. Vitals were monitored and recorded before, during, and after scanning.
|
Post-Scan Measures for PPM/ICDs Scanned With RF Assure
n=40 Participants
The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.
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Base Rate Measurement Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned w/ RF Assure
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60 bpm
Standard Deviation 10.27
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60 bpm
Standard Deviation 10.27
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PRIMARY outcome
Timeframe: Baseline and 15 minutesPopulation: 34 of 40 participants' Max Tracking Rate was measured. 6 MTRs were not measured or unable to be measured during testing. The PTE temporary pacing participants were not included in this analysis because temporary devices do not have capabilities for interrogation (ie: recording max tracking rate changes).
The max tracking rate on the CIEDs was measured prior to scanning with the sponge and post scanning with sponge. The max tracking rate is the maximum atrial rate at which a pacemaker will deliver a ventricular pacing stimulus following each sensed atrial beat. Below, the median and standard deviation are presented. Please note that multiple post-scan assessments were not made for any patient.
Outcome measures
| Measure |
Pre-Scan Measures for PPM/ICDs Scanned With RF Assure
n=34 Participants
The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.
RF Assure Scanning: CIED and temporary pacemaker patients were scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was be conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology. Vitals were monitored and recorded before, during, and after scanning.
|
Post-Scan Measures for PPM/ICDs Scanned With RF Assure
n=34 Participants
The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.
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Max Tracking Rate Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure
|
130 bpm
Standard Deviation 14.51
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130 bpm
Standard Deviation 14.51
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PRIMARY outcome
Timeframe: Baseline and 15 minutesPopulation: 31 patients were evaluated of the 40 in this analysis of the AV Delay 9 paced AV Delays were either not measured or unable to be measured during this study. The PTE participants were not included in this analysis because temporary devices do not have capabilities for interrogation (ie: recording AV Delay Changes).
The atrio-ventricular delay was measured prior to scanning with sponge and post RF scanning with sponge. Please note that multiple post-scan assessments were not made for any of the patients presented here.
Outcome measures
| Measure |
Pre-Scan Measures for PPM/ICDs Scanned With RF Assure
n=31 Participants
The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.
RF Assure Scanning: CIED and temporary pacemaker patients were scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was be conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology. Vitals were monitored and recorded before, during, and after scanning.
|
Post-Scan Measures for PPM/ICDs Scanned With RF Assure
n=31 Participants
The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.
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Atrio-ventricular (AV) Delay Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure
Sensed AV Delay
|
230 ms
Standard Deviation 69.3
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230 ms
Standard Deviation 69.3
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Atrio-ventricular (AV) Delay Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure
Paced AV Delay
|
250 ms
Standard Deviation 68.3
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250 ms
Standard Deviation 68.3
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PRIMARY outcome
Timeframe: Baseline and 15 minutesPopulation: Of all participants, only 24 were analyzed in this outcome, as their devices reported battery life in millivolts (while other devices reported battery life in % or years). The PTE temporary pacing participants weren't included in this analysis because temporary devices do not have capabilities for interrogation.
Of the patients enrolled, battery capacity changes were measured prior to and post RF scanning with sponge. Multiple post-scan assessments were not made for any of the patients presented here.
Outcome measures
| Measure |
Pre-Scan Measures for PPM/ICDs Scanned With RF Assure
n=24 Participants
The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.
RF Assure Scanning: CIED and temporary pacemaker patients were scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was be conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology. Vitals were monitored and recorded before, during, and after scanning.
|
Post-Scan Measures for PPM/ICDs Scanned With RF Assure
n=24 Participants
The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.
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|---|---|---|
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Battery Capacity Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure
|
2.745 mV
Standard Deviation 0.23
|
2.744 mV
Standard Deviation 0.23
|
PRIMARY outcome
Timeframe: Baseline and 15 minutesPopulation: 40 subjects were analyzed. Note that not all had both RA, RV, and LV leads. Therefore, the number of leads (and therefore their impedance values reported below) does not match for each group. The PTE temporary pacing participants were not included in this analysis because temporary devices do not have capabilities for interrogation.
The impedance values of right ventricle (RV), right atrium (RA), and left ventricle (LV) leads was measured prior to RF scanning with sponge and post RF scanning with sponge. Multiple post-scan assessments were not made for any patient represented here.
Outcome measures
| Measure |
Pre-Scan Measures for PPM/ICDs Scanned With RF Assure
n=40 Participants
The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.
RF Assure Scanning: CIED and temporary pacemaker patients were scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was be conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology. Vitals were monitored and recorded before, during, and after scanning.
|
Post-Scan Measures for PPM/ICDs Scanned With RF Assure
n=40 Participants
The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.
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|---|---|---|
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Pacing Impedance Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure
RA Impedance
|
500.1 ohms
Standard Deviation 161.18
|
495.1 ohms
Standard Deviation 161.48
|
|
Pacing Impedance Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure
RV Impedance
|
531.9 ohms
Standard Deviation 135.96
|
530.6 ohms
Standard Deviation 135.08
|
|
Pacing Impedance Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure
LV Impedance
|
592.8 ohms
Standard Deviation 255.19
|
610.1 ohms
Standard Deviation 236.89
|
PRIMARY outcome
Timeframe: Baseline and 15 minutesPopulation: SVC and RV Coils are specific to ICDs, and therefore, PPMs and Temporary Pacemakers were not included in this analysis.
The shock impedance changes were measured (right ventricle (RV) coil and superior vena cava (SVC) coil) prior to and post RF scanning with sponge. This was measured by performing a device interrogation in the electrophysiology (EP) lab. Multiple post-scan measurements were not taken for any of the patients presented here.
Outcome measures
| Measure |
Pre-Scan Measures for PPM/ICDs Scanned With RF Assure
n=20 Participants
The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.
RF Assure Scanning: CIED and temporary pacemaker patients were scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was be conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology. Vitals were monitored and recorded before, during, and after scanning.
|
Post-Scan Measures for PPM/ICDs Scanned With RF Assure
n=20 Participants
The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.
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|---|---|---|
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Shock Impedance Changes With Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure
RV Coil
|
51.30 ohms
Standard Deviation 18.36
|
51.5 ohms
Standard Deviation 18.14
|
|
Shock Impedance Changes With Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure
SVC Coil
|
53.45 ohms
Standard Deviation 17.53
|
53.70 ohms
Standard Deviation 17.13
|
PRIMARY outcome
Timeframe: Baseline and 15 minutesPopulation: 32 of the 40 participants were evaluated in this study for P and R measurements. 8 patients' devices either didn't have the P or R measured or they was unable to be measured. The PTE temporary pacing participants were not included in this analysis because temporary devices do not have capabilities for interrogation.
The P and R waves were measured via device interrogation prior to and post RF scanning with sponge. Multiple post-scan measurements were not made for any of the participants represented here.
Outcome measures
| Measure |
Pre-Scan Measures for PPM/ICDs Scanned With RF Assure
n=32 Participants
The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.
RF Assure Scanning: CIED and temporary pacemaker patients were scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was be conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology. Vitals were monitored and recorded before, during, and after scanning.
|
Post-Scan Measures for PPM/ICDs Scanned With RF Assure
n=32 Participants
The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.
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|---|---|---|
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Changes in P & R Wave Measurements in Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure
P Wave
|
2.5 mV
Standard Deviation 1.38
|
2.469 mV
Standard Deviation 1.37
|
|
Changes in P & R Wave Measurements in Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure
R Wave
|
10.73 mV
Standard Deviation 5.25
|
10.76 mV
Standard Deviation 5.29
|
PRIMARY outcome
Timeframe: Baseline and 15 minutesPopulation: Because not all devices are equipped with RA, RV, and LV leads, note the population values in the below table for each group: right atrium (RA) thresholds, right ventricle (RV) thresholds, and left ventricle (LV) thresholds. The PTE participants were not included in this analysis because temporary devices do not have capabilities for interrogation.
Via device interrogation, capture threshold changes (the minimum amount of electricity that the box has to emit to pace the heart) were measured prior to and post RF Scanning with sponge. Multiple post-scan measurements were not taken for any participants presented here.
Outcome measures
| Measure |
Pre-Scan Measures for PPM/ICDs Scanned With RF Assure
n=40 Participants
The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.
RF Assure Scanning: CIED and temporary pacemaker patients were scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was be conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology. Vitals were monitored and recorded before, during, and after scanning.
|
Post-Scan Measures for PPM/ICDs Scanned With RF Assure
n=40 Participants
The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.
|
|---|---|---|
|
Capture Threshold Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure
RA Threshold
|
0.806 V
Standard Deviation 0.35
|
0.819 V
Standard Deviation 0.36
|
|
Capture Threshold Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure
RV Threshold
|
0.955 V
Standard Deviation 0.49
|
0.972 V
Standard Deviation 0.50
|
|
Capture Threshold Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure
LV Threshold
|
2.616 V
Standard Deviation 1.16
|
2.320 V
Standard Deviation 1.16
|
Adverse Events
RF Assure Scanning
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ulrika Birgersdotter-Green
UC San Diego School of Medicine
Phone: 858-657-5310
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place