Trial Outcomes & Findings for Using Electrical Nerve Stimulation to Control Atrial Fibrillation (NCT NCT04529941)
NCT ID: NCT04529941
Last Updated: 2025-10-02
Results Overview
Using mobile cardiac telemetry (MCT) to observe if AF burden is lower at 2 Weeks compared to Baseline in the active treatment group than the sham control group
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
2 weeks
Results posted on
2025-10-02
Participant Flow
46 subjects were enrolled in the study and underwent mobile cardiac telemetry and echocardiogram to determine eligibility. Out of this group, 16 subjects were deemed eligible and completed a baseline visit prior to the procedure and randomization.
Participant milestones
| Measure |
Experimental Group
Will receive stimulation ScNS at 3.5mA output
Device Implant with Active Treatment: ScNS at 3.5mA output for 2 weeks
|
Control (Sham) Group
Does not receive therapy
Device Implant without Active Treatment: No device output for 2 weeks.
After Week 3, has the option to forego the Week 12 Follow Up visit and, instead, repeat device implantation to crossover to the experimental group to receive stimulation. Will repeat all visits and assessments.
|
|---|---|---|
|
Device Implantation and Randomization
STARTED
|
8
|
8
|
|
Device Implantation and Randomization
COMPLETED
|
8
|
8
|
|
Device Implantation and Randomization
NOT COMPLETED
|
0
|
0
|
|
Week 1 Follow Up
STARTED
|
8
|
8
|
|
Week 1 Follow Up
COMPLETED
|
8
|
8
|
|
Week 1 Follow Up
NOT COMPLETED
|
0
|
0
|
|
Week 2 Follow Up and Device Removal
STARTED
|
8
|
8
|
|
Week 2 Follow Up and Device Removal
COMPLETED
|
8
|
8
|
|
Week 2 Follow Up and Device Removal
NOT COMPLETED
|
0
|
0
|
|
Week 3 Follow Up
STARTED
|
8
|
8
|
|
Week 3 Follow Up
COMPLETED
|
8
|
8
|
|
Week 3 Follow Up
NOT COMPLETED
|
0
|
0
|
|
Crossover Option
STARTED
|
0
|
1
|
|
Crossover Option
COMPLETED
|
0
|
1
|
|
Crossover Option
NOT COMPLETED
|
0
|
0
|
|
Week 12/Month 3 Follow Up
STARTED
|
8
|
7
|
|
Week 12/Month 3 Follow Up
COMPLETED
|
7
|
7
|
|
Week 12/Month 3 Follow Up
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Experimental Group
Will receive stimulation ScNS at 3.5mA output
Device Implant with Active Treatment: ScNS at 3.5mA output for 2 weeks
|
Control (Sham) Group
Does not receive therapy
Device Implant without Active Treatment: No device output for 2 weeks.
After Week 3, has the option to forego the Week 12 Follow Up visit and, instead, repeat device implantation to crossover to the experimental group to receive stimulation. Will repeat all visits and assessments.
|
|---|---|---|
|
Week 12/Month 3 Follow Up
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
Baseline characteristics by cohort
| Measure |
Experimental Group
n=6 Participants
Will receive stimulation ScNS at 3.5mA output
Device Implant with Active Treatment: ScNS at 3.5mA output for 2 weeks
|
Control Group
n=6 Participants
Does not receive therapy
Device Implant without Active Treatment: No device output for 2 weeks
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 7.4 • n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
57.8 years
STANDARD_DEVIATION 12.3 • n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
60.9 years
STANDARD_DEVIATION 10.2 • n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
1 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
4 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
5 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
8 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
6 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
12 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
1 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
2 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
1 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
2 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
4 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
8 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
6 participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
12 participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Smoking
None
|
5 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
4 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
9 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Smoking
Past Use
|
1 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
2 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
3 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Alcohol abuse
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
1 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
1 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Hypertension
|
4 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
4 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
8 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Stroke
|
1 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
1 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Coronary Artery Disease
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
2 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
2 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Hyperlipidemia
|
3 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
4 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
7 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Heart failure with reduced ejection fraction (HFrEF)
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Heart failure with preserved ejection fraction (HFpEF)
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Peripheral vascular disease (PVD)
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
COPD
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Chronic renal failure/ kidney injury
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Asthma
|
1 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
1 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Diabetes mellitus
|
2 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
2 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
On chronic dialysis
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Sleep disordered breathing
|
3 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
1 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
4 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Previous open heart surgery
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Coronary Artery Bypass Graft
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
0 Participants
n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
Initial weight
|
91.8 kilograms
STANDARD_DEVIATION 12.2 • n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
102.8 kilograms
STANDARD_DEVIATION 45.3 • n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
97.3 kilograms
STANDARD_DEVIATION 32.1 • n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
|
BMI
|
30.9 kg/m^2
STANDARD_DEVIATION 6.0 • n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
32.4 kg/m^2
STANDARD_DEVIATION 11.1 • n=7 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
31.6 kg/m^2
STANDARD_DEVIATION 8.6 • n=5 Participants • Due to low baseline burden (\<1%), 2 randomized subjects from each group were excluded from efficacy analysis.
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: We initially randomized 16 patients with paroxysmal AF. However, the DSMB decided that those with \< 1% AF per week during the eligibility visit did not have sufficient AF burden to detect therapy effects. Therefore, all patients (2 in each group) with \< 1% baseline AF burden were excluded from the analysis as screen failures. The remaining 12 included 8 men and 4 women with an average age of 60.9 ± 10.2 years
Using mobile cardiac telemetry (MCT) to observe if AF burden is lower at 2 Weeks compared to Baseline in the active treatment group than the sham control group
Outcome measures
| Measure |
Experimental Group
n=6 Participants
Will receive stimulation ScNS at 3.5mA output
Device Implant with Active Treatment: ScNS at 3.5mA output for 2 weeks
|
Control Group
n=6 Participants
Does not receive therapy
Device Implant without Active Treatment: No device output for 2 weeks
|
|---|---|---|
|
Change in AF Burden
|
-0.4 percentage of time in AF
Interval -7.9 to 4.22
|
-2.4 percentage of time in AF
Interval -14.1 to 16.6
|
SECONDARY outcome
Timeframe: 3 MonthsPopulation: 1 patient who crossed over to the stimulation group did not have the 12-week visit
Improved ventricular rate control during AF. AF-Free time was separated. Rate control during AF was categorized as the VR \<=110 BPM stage.
Outcome measures
| Measure |
Experimental Group
n=6 Participants
Will receive stimulation ScNS at 3.5mA output
Device Implant with Active Treatment: ScNS at 3.5mA output for 2 weeks
|
Control Group
n=6 Participants
Does not receive therapy
Device Implant without Active Treatment: No device output for 2 weeks
|
|---|---|---|
|
Ventricular Rate Control
Eligibility · AF-Free
|
0 Participants
|
0 Participants
|
|
Ventricular Rate Control
Eligibility · VR ≤ 110 bpm
|
4 Participants
|
4 Participants
|
|
Ventricular Rate Control
Eligibility · VR > 110 bpm
|
2 Participants
|
2 Participants
|
|
Ventricular Rate Control
Week 1 · AF-Free
|
1 Participants
|
1 Participants
|
|
Ventricular Rate Control
Week 1 · VR ≤ 110 bpm
|
2 Participants
|
4 Participants
|
|
Ventricular Rate Control
Week 1 · VR > 110 bpm
|
3 Participants
|
1 Participants
|
|
Ventricular Rate Control
Week 2 · AF-Free
|
0 Participants
|
1 Participants
|
|
Ventricular Rate Control
Week 2 · VR ≤ 110 bpm
|
2 Participants
|
4 Participants
|
|
Ventricular Rate Control
Week 2 · VR > 110 bpm
|
4 Participants
|
1 Participants
|
|
Ventricular Rate Control
Week 3 · AF-Free
|
0 Participants
|
2 Participants
|
|
Ventricular Rate Control
Week 3 · VR ≤ 110 bpm
|
1 Participants
|
4 Participants
|
|
Ventricular Rate Control
Week 3 · VR > 110 bpm
|
5 Participants
|
0 Participants
|
|
Ventricular Rate Control
3 Months · AF-Free
|
0 Participants
|
1 Participants
|
|
Ventricular Rate Control
3 Months · VR ≤ 110 bpm
|
3 Participants
|
3 Participants
|
|
Ventricular Rate Control
3 Months · VR > 110 bpm
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: We initially randomized 16 patients with paroxysmal AF. However, the DSMB decided that those with \< 1% AF per week during the eligibility visit did not have sufficient AF burden to detect therapy effects. Therefore, all patients (2 in each group) with \< 1% baseline AF burden were excluded from the analysis as screen failures. The sham group was given the option to crossover to the experimental group after Week 3. One participant crossed over, therefore for month 3 data, N = 5.
Reduction of SKNA taken from ME6000 (biomonitor) during Six Minute Walk test. SKNA is sympathetic nerve activity (SNA) recording from a skin-patch electrode used with the ME6000.
Outcome measures
| Measure |
Experimental Group
n=6 Participants
Will receive stimulation ScNS at 3.5mA output
Device Implant with Active Treatment: ScNS at 3.5mA output for 2 weeks
|
Control Group
n=6 Participants
Does not receive therapy
Device Implant without Active Treatment: No device output for 2 weeks
|
|---|---|---|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Month 3 - Lead 1 - Recovery
|
1.42 microvolts
Standard Deviation 0.45
|
1.57 microvolts
Standard Deviation 0.14
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Baseline - Lead 1 - At Rest
|
0.93 microvolts
Standard Deviation 0.30
|
1.12 microvolts
Standard Deviation 0.85
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Baseline - Lead 2 - At Rest
|
0.89 microvolts
Standard Deviation 0.30
|
0.85 microvolts
Standard Deviation 0.11
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Baseline - Lead 1 - Stress
|
2.15 microvolts
Standard Deviation 0.76
|
1.65 microvolts
Standard Deviation 0.32
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Baseline - Lead 2 - Stress
|
1.98 microvolts
Standard Deviation 0.46
|
1.59 microvolts
Standard Deviation 0.45
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Baseline - Lead 1 - Recovery
|
1.45 microvolts
Standard Deviation 0.28
|
1.27 microvolts
Standard Deviation 0.39
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Baseline - Lead 2 - Recovery
|
1.23 microvolts
Standard Deviation 0.27
|
0.97 microvolts
Standard Deviation 0.26
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Procedure - Lead 1 - At Rest
|
1.31 microvolts
Standard Deviation 0.36
|
1.06 microvolts
Standard Deviation 0.29
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Procedure - Lead 2 - At Rest
|
1.69 microvolts
Standard Deviation 0.84
|
1.00 microvolts
Standard Deviation 0.30
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Week 1 - Lead 1 - At Rest
|
0.97 microvolts
Standard Deviation 0.52
|
0.95 microvolts
Standard Deviation 0.31
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Week 1 - Lead 2 - At Rest
|
0.88 microvolts
Standard Deviation 0.47
|
0.85 microvolts
Standard Deviation 0.26
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Week 1 - Lead 1 - Stress
|
2.12 microvolts
Standard Deviation 0.54
|
1.55 microvolts
Standard Deviation 0.20
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Week 1 - Lead 2 - Stress
|
1.92 microvolts
Standard Deviation 0.61
|
1.43 microvolts
Standard Deviation 0.28
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Week 1 - Lead 1 - Recovery
|
1.78 microvolts
Standard Deviation 1.47
|
1.13 microvolts
Standard Deviation 0.22
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Week 1 - Lead 2 - Recovery
|
1.08 microvolts
Standard Deviation 0.27
|
0.94 microvolts
Standard Deviation 0.17
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Week 2 - Lead 1 - At Rest
|
0.98 microvolts
Standard Deviation 0.53
|
0.89 microvolts
Standard Deviation 0.23
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Week 2 - Lead 2 - At Rest
|
0.88 microvolts
Standard Deviation 0.45
|
0.74 microvolts
Standard Deviation 0.22
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Week 2 - Lead 1 - Stress
|
2.16 microvolts
Standard Deviation 0.55
|
1.65 microvolts
Standard Deviation 0.35
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Week 2 - Lead 2 - Stress
|
1.95 microvolts
Standard Deviation 0.51
|
1.41 microvolts
Standard Deviation 0.21
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Week 2 - Lead 1 - Recovery
|
1.19 microvolts
Standard Deviation 0.27
|
1.15 microvolts
Standard Deviation 0.24
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Week 2 - Lead 2 - Recovery
|
0.93 microvolts
Standard Deviation 0.18
|
0.84 microvolts
Standard Deviation 0.13
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Week 3 - Lead 1 - At Rest
|
0.85 microvolts
Standard Deviation 0.27
|
1.05 microvolts
Standard Deviation 0.39
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Week 3 - Lead 2 - At Rest
|
0.74 microvolts
Standard Deviation 0.26
|
0.88 microvolts
Standard Deviation 0.33
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Week 3 - Lead 1 - Stress
|
2.26 microvolts
Standard Deviation 0.54
|
1.69 microvolts
Standard Deviation 0.44
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Week 3 - Lead 2 - Stress
|
2.11 microvolts
Standard Deviation 0.52
|
1.60 microvolts
Standard Deviation 0.37
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Week 3 - Lead 1 - Recovery
|
1.44 microvolts
Standard Deviation 0.35
|
1.40 microvolts
Standard Deviation 0.86
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Week 3 - Lead 2 - Recovery
|
1.14 microvolts
Standard Deviation 0.28
|
0.87 microvolts
Standard Deviation 0.19
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Month 3 - Lead 1 - At Rest
|
1.04 microvolts
Standard Deviation 0.48
|
1.26 microvolts
Standard Deviation 0.64
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Month 3 - Lead 2 - At Rest
|
0.93 microvolts
Standard Deviation 0.34
|
0.82 microvolts
Standard Deviation 0.19
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Month 3 - Lead 1 - Stress
|
2.20 microvolts
Standard Deviation 0.56
|
1.86 microvolts
Standard Deviation 0.62
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Month 3 - Lead 2 - Stress
|
2.00 microvolts
Standard Deviation 0.53
|
1.49 microvolts
Standard Deviation 0.33
|
|
Average Skin Sympathetic Nerve Activity (SKNA)
Month 3 - Lead 2 - Recovery
|
1.10 microvolts
Standard Deviation 0.37
|
1.01 microvolts
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state. EQ-5D-5L health scores range from 5 (11111) to 25 (55555), where 5 is the best possible health state.
Improvement of quality of life as measured by the EQ-5D-5L
Outcome measures
| Measure |
Experimental Group
n=6 Participants
Will receive stimulation ScNS at 3.5mA output
Device Implant with Active Treatment: ScNS at 3.5mA output for 2 weeks
|
Control Group
n=6 Participants
Does not receive therapy
Device Implant without Active Treatment: No device output for 2 weeks
|
|---|---|---|
|
Quality of Life - EQ-5D-5L
Baseline (total score)
|
7.7 score on a scale
Standard Deviation 4.6
|
6.3 score on a scale
Standard Deviation 0.8
|
|
Quality of Life - EQ-5D-5L
Week 3 (total score)
|
7.2 score on a scale
Standard Deviation 3.0
|
6.2 score on a scale
Standard Deviation 0.8
|
|
Quality of Life - EQ-5D-5L
Week 12 (total score)
|
9.3 score on a scale
Standard Deviation 5.9
|
6.0 score on a scale
Standard Deviation 0.7
|
|
Quality of Life - EQ-5D-5L
Baseline (index value)
|
0.8 score on a scale
Standard Deviation 0.4
|
0.9 score on a scale
Standard Deviation 0.1
|
|
Quality of Life - EQ-5D-5L
Week 3 (index value)
|
0.8 score on a scale
Standard Deviation 0.2
|
0.9 score on a scale
Standard Deviation 0.0
|
|
Quality of Life - EQ-5D-5L
Week 12 (index value)
|
0.7 score on a scale
Standard Deviation 0.5
|
0.9 score on a scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Overall or subscale scores range from 0-100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered).
Improvement of quality of life as measured by the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire. A score of 0 indicates the most severe symptoms or disability and a score of 100 indicates no limitation or disability. Thus, higher scores on the AFEQT instrument indicate better health status.
Outcome measures
| Measure |
Experimental Group
n=6 Participants
Will receive stimulation ScNS at 3.5mA output
Device Implant with Active Treatment: ScNS at 3.5mA output for 2 weeks
|
Control Group
n=6 Participants
Does not receive therapy
Device Implant without Active Treatment: No device output for 2 weeks
|
|---|---|---|
|
Quality of Life - AFEQT
Baseline AFEQT Global Score
|
65.7 units on a scale
Standard Deviation 29.8
|
49.7 units on a scale
Standard Deviation 28.5
|
|
Quality of Life - AFEQT
Week 3 AFEQT Global Score
|
61.6 units on a scale
Standard Deviation 28.4
|
63.1 units on a scale
Standard Deviation 15.3
|
|
Quality of Life - AFEQT
Week 12 AFEQT Global Score
|
63.9 units on a scale
Standard Deviation 29.9
|
71.7 units on a scale
Standard Deviation 20.7
|
Adverse Events
Experimental Group
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Control Group Crossed Over to Experimental
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental Group
n=8 participants at risk
Will receive stimulation ScNS at 3.5mA output
Device Implant with Active Treatment: ScNS at 3.5mA output for 2 weeks
|
Control Group
n=8 participants at risk
Does not receive therapy
Device Implant without Active Treatment: No device output for 2 weeks
|
Control Group Crossed Over to Experimental
n=1 participants at risk
1 sham participant chose to crossover and did not experience any adverse events to report.
|
|---|---|---|---|
|
Cardiac disorders
NA (elective left heart catheterization)
|
12.5%
1/8 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
0.00%
0/8 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
0.00%
0/1 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
|
Cardiac disorders
Brief "Black Out" Periods
|
12.5%
1/8 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
0.00%
0/8 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
0.00%
0/1 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
Other adverse events
| Measure |
Experimental Group
n=8 participants at risk
Will receive stimulation ScNS at 3.5mA output
Device Implant with Active Treatment: ScNS at 3.5mA output for 2 weeks
|
Control Group
n=8 participants at risk
Does not receive therapy
Device Implant without Active Treatment: No device output for 2 weeks
|
Control Group Crossed Over to Experimental
n=1 participants at risk
1 sham participant chose to crossover and did not experience any adverse events to report.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
NA (Skin Irritation)
|
50.0%
4/8 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
87.5%
7/8 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
0.00%
0/1 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
|
Skin and subcutaneous tissue disorders
NA (Bleeding)
|
0.00%
0/8 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
25.0%
2/8 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
0.00%
0/1 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
|
Skin and subcutaneous tissue disorders
NA (Pain)
|
37.5%
3/8 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
12.5%
1/8 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
0.00%
0/1 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
|
Skin and subcutaneous tissue disorders
NA (Goosebumps)
|
12.5%
1/8 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
0.00%
0/8 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
0.00%
0/1 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
|
Skin and subcutaneous tissue disorders
NA (Hot Flashes)
|
12.5%
1/8 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
0.00%
0/8 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
0.00%
0/1 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
|
Skin and subcutaneous tissue disorders
NA (Skin Redness)
|
12.5%
1/8 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
0.00%
0/8 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
0.00%
0/1 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
|
Musculoskeletal and connective tissue disorders
Extremity weakness, swelling, and/or pain
|
12.5%
1/8 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
0.00%
0/8 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
0.00%
0/1 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
|
Skin and subcutaneous tissue disorders
Allergic reaction
|
0.00%
0/8 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
12.5%
1/8 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
0.00%
0/1 • Adverse event data was collected for participants from Eligibility timepoint until Week 12/Month 3 MCT monitoring was completed.
A crossover option was only given to those randomized to sham group initially, after the completion of the primary endpoint (Week 3 FU).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place