Atrial Fibrillation
Conditions
Brief summary
The purpose of this study is to examine if sending mild electrical signals just under your skin will improve atrial fibrillation symptoms by controlling your heart rate.
Detailed description
Patients will have a 1:1 randomization to receive subcutaneous electrical nerve stimulation (ScNS) to observe if the stimulation can reduce atrial fibrillation burden in patients with symptomatic atrial fibrillation (AF). All subjects will undergo the implant of a neurostimulator lead. The experimental group will receive stimulation and the control group will not receive stimulation. All subjects will complete the same follow up visits to compare the 2 groups. Primary Objective: To test the hypothesis that chronic subcutaneous nerve stimulation can reduce AF burden in patients with severe symptomatic AF unresponsive to conventional therapies The secondary objective: To test the hypotheses that the effect of ScNS on the following endpoints is different between the two randomization groups: 1. Time-dependent reduction of AF burden 2. Effects of ScNS on ventricular rate control during AF 3. Reduction of SKNA 4. Improvement of quality of life The study will enroll patients with symptomatic atrial fibrillation unresponsive to conventional therapy defined by not responding to at least 1 antiarrhythmic drug. The study will enroll 30 patients, including 15 men and 15 women between the 18 and 75 years old. There will be no sex/gender/racial/ethnic based exclusion. Patients will be enrolled from the Cedars Sinai Medical Center. The patients will undergo surgical implantation of an externalized lead under the skin on the chest wall. The wire is then connected to a neurostimulator. The experimental group (Group A) will receive ScNS (3.5mA) for two weeks. The sham group (Group B) will receive sham (0 mA) stimulation for two weeks. The AF burden will be assessed by a 7-day mobile cardiac telemetry device provided by Preventice. An additional mobile cardiac telemetry device, Bittium Faros, will also be worn at similar time points to monitor skin sympathetic nerve activity. An Apple watch will be used to collect additional information on the frequencies of AF between the Baseline Visit until the 3 Month Visit 7 Day Mobile Cardiac Telemetry is complete. After completion of the week 3 visit, the sham group (Group B) will be able to receive ScNS (3.5 mA) for two weeks. The AF burden will be assessed post-procedure by mobile cardiac telemetry by Preventice and Bittium Faros Study duration: 36 Months Subject duration: up to 5 months.
Interventions
DEVICEDevice Implant with Active Treatment
ScNS at 3.5mA output for 2 weeks
DEVICEDevice Implant without Active Treatment
No device output for 2 weeks
Sponsors
Indiana University
National Institutes of Health (NIH)
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Subjects will not be aware whether the ScNS is turned on or off. However, after three weeks from the initial surgery, control subjects that decide to the second procedure will be aware of what group they were randomized to.
Intervention model description
Patients will have a 1:1 randomization to receive subcutaneous electrical nerve stimulation (ScNS) to observe if the stimulation can reduce atrial fibrillation burden in patients with symptomatic atrial fibrillation (AF). All subjects will undergo the implant of a neurostimulator lead. The experimental group will receive stimulation and the control group will not receive stimulation. All subjects will complete the same follow up visits comparing the 2 groups. The control group will have an option to cross over to the experimental group 3 weeks post-randomization to receive the stimulation. They will repeat the baseline visit, procedure visit and all follow-up visits post-procedure.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 75 years of age * Symptomatic Paroxysmal AF. * Symptomatic paroxysmal AF is defined by AF with patient-reported perception of one or more of the following symptoms: palpitations, dizziness/presyncope, syncope, dyspnea, chest pain, malaise, and fatigue and activity intolerance. * There is at least one ECG-documented AF episode. * Unresponsive to conventional therapy is defined by not responding to at least 1 antiarrhythmic drug (class I, class III, or atrioventricular nodal blocker). * The left atrial size \<50 mm by transthoracic echocardiography documented by eligibility visit echocardiogram * Documented atrial fibrillation as defined as atrial fibrillation \>30 seconds in duration with an atrial fibrillation burden determined by a minimum of 7 days of continuous ePatch monitoring within 6 months before surgery.
Exclusion criteria
* Patients without AF episodes during monitoring period will be excluded from the study and count as screen failure * Left ventricular ejection fraction \<40% * Heart failure with functional classes III or IV * Recurrent vasovagal syncope * Valvular AF (severe mitral regurgitation, mitral stenosis) * Congenital heart diseases * Wolff Parkinson-White Syndrome * Stroke within the past 6 months * Any history of myocardial infarction * Malignancies with a life expectancy of \< 1 year * A history of ablation procedures to treat left atrial tachyarrhythmias or other serious comorbidity * Any history of sustained ventricular tachycardia (VT) defined by (1) \> 30 s in duration or (2) \< 30 s in duration, but is associated with hemodynamic consequences such as hypotension and syncope. * Patients with a vagal nerve stimulator * Active thyrotoxicosis * Sick sinus syndrome with symptomatic bradycardia * Heart rate \< 50 beats per minute in sinus rhythm on 12-lead ECG * Systolic blood pressure \< 90 mm Hg * Any experimental medication concomitantly or within 4 weeks of participation in the study * Subjects with cardiac implantable electronic device (CIED) such as pacemakers and implantable cardioverter-defibrillators (ICDs) * Pre-existing neuromodulation devices, such as vagal nerve stimulators, spinal cord stimulators and sacral nerve stimulators * People with a history of allergy to ECG electrodes, adhesive tape, or nylon * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in AF Burden | 2 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventricular Rate Control | 3 Months | Improved ventricular rate control during AF. AF-Free time was separated. Rate control during AF was categorized as the VR \<=110 BPM stage. |
| Average Skin Sympathetic Nerve Activity (SKNA) | 3 months | 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. |
| Quality of Life - EQ-5D-5L | 3 months | Improvement of quality of life as measured by the EQ-5D-5L |
| Quality of Life - AFEQT | 3 months | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Experimental Group Will receive stimulation ScNS at 3.5mA output
Device Implant with Active Treatment: ScNS at 3.5mA output for 2 weeks | 6 |
| Control Group Does not receive therapy
Device Implant without Active Treatment: No device output for 2 weeks | 6 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Week 12/Month 3 Follow Up | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Experimental Group | Total | Control Group |
|---|---|---|---|
| Age, Continuous | 64.0 years STANDARD_DEVIATION 7.4 | 60.9 years STANDARD_DEVIATION 10.2 | 57.8 years STANDARD_DEVIATION 12.3 |
| Alcohol abuse | 0 Participants | 1 Participants | 1 Participants |
| Asthma | 1 Participants | 1 Participants | 0 Participants |
| BMI | 30.9 kg/m^2 STANDARD_DEVIATION 6 | 31.6 kg/m^2 STANDARD_DEVIATION 8.6 | 32.4 kg/m^2 STANDARD_DEVIATION 11.1 |
| Chronic renal failure/ kidney injury | 0 Participants | 0 Participants | 0 Participants |
| COPD | 0 Participants | 0 Participants | 0 Participants |
| Coronary Artery Bypass Graft | 0 Participants | 0 Participants | 0 Participants |
| Coronary Artery Disease | 0 Participants | 2 Participants | 2 Participants |
| Diabetes mellitus | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 12 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Heart failure with preserved ejection fraction (HFpEF) | 0 Participants | 0 Participants | 0 Participants |
| Heart failure with reduced ejection fraction (HFrEF) | 0 Participants | 0 Participants | 0 Participants |
| Hyperlipidemia | 3 Participants | 7 Participants | 4 Participants |
| Hypertension | 4 Participants | 8 Participants | 4 Participants |
| Initial weight | 91.8 kilograms STANDARD_DEVIATION 12.2 | 97.3 kilograms STANDARD_DEVIATION 32.1 | 102.8 kilograms STANDARD_DEVIATION 45.3 |
| On chronic dialysis | 0 Participants | 0 Participants | 0 Participants |
| Peripheral vascular disease (PVD) | 0 Participants | 0 Participants | 0 Participants |
| Previous open heart surgery | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 8 Participants | 4 Participants |
| Region of Enrollment United States | 6 participants | 12 participants | 6 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 1 Participants |
| Sex: Female, Male Male | 3 Participants | 8 Participants | 5 Participants |
| Sleep disordered breathing | 3 Participants | 4 Participants | 1 Participants |
| Smoking None | 5 Participants | 9 Participants | 4 Participants |
| Smoking Past Use | 1 Participants | 3 Participants | 2 Participants |
| Stroke | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 1 |
| other Total, other adverse events | 6 / 8 | 7 / 8 | 0 / 1 |
| serious Total, serious adverse events | 1 / 8 | 0 / 8 | 0 / 1 |
Outcome results
Primary
Change in AF Burden
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
Time frame: 2 weeks
Population: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Experimental Group | Change in AF Burden | -0.4 percentage of time in AF |
| Control Group | Change in AF Burden | -2.4 percentage of time in AF |
Secondary
Average Skin Sympathetic Nerve Activity (SKNA)
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.
Time frame: 3 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 1 - Lead 1 - At Rest | 0.97 microvolts | Standard Deviation 0.52 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Baseline - Lead 2 - At Rest | 0.89 microvolts | Standard Deviation 0.3 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Baseline - Lead 1 - Stress | 2.15 microvolts | Standard Deviation 0.76 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Baseline - Lead 2 - Stress | 1.98 microvolts | Standard Deviation 0.46 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Baseline - Lead 1 - Recovery | 1.45 microvolts | Standard Deviation 0.28 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Baseline - Lead 2 - Recovery | 1.23 microvolts | Standard Deviation 0.27 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Procedure - Lead 1 - At Rest | 1.31 microvolts | Standard Deviation 0.36 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Procedure - Lead 2 - At Rest | 1.69 microvolts | Standard Deviation 0.84 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Baseline - Lead 1 - At Rest | 0.93 microvolts | Standard Deviation 0.3 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 1 - Lead 2 - At Rest | 0.88 microvolts | Standard Deviation 0.47 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 1 - Lead 1 - Stress | 2.12 microvolts | Standard Deviation 0.54 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 1 - Lead 2 - Stress | 1.92 microvolts | Standard Deviation 0.61 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 1 - Lead 1 - Recovery | 1.78 microvolts | Standard Deviation 1.47 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 2 - Lead 1 - Recovery | 1.19 microvolts | Standard Deviation 0.27 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 2 - Lead 2 - Recovery | 0.93 microvolts | Standard Deviation 0.18 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 3 - Lead 1 - At Rest | 0.85 microvolts | Standard Deviation 0.27 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 3 - Lead 2 - At Rest | 0.74 microvolts | Standard Deviation 0.26 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Month 3 - Lead 2 - Recovery | 1.10 microvolts | Standard Deviation 0.37 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 1 - Lead 2 - Recovery | 1.08 microvolts | Standard Deviation 0.27 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 2 - Lead 1 - At Rest | 0.98 microvolts | Standard Deviation 0.53 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 2 - Lead 2 - At Rest | 0.88 microvolts | Standard Deviation 0.45 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 2 - Lead 1 - Stress | 2.16 microvolts | Standard Deviation 0.55 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 2 - Lead 2 - Stress | 1.95 microvolts | Standard Deviation 0.51 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 3 - Lead 1 - Stress | 2.26 microvolts | Standard Deviation 0.54 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 3 - Lead 2 - Stress | 2.11 microvolts | Standard Deviation 0.52 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 3 - Lead 1 - Recovery | 1.44 microvolts | Standard Deviation 0.35 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 3 - Lead 2 - Recovery | 1.14 microvolts | Standard Deviation 0.28 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Month 3 - Lead 1 - At Rest | 1.04 microvolts | Standard Deviation 0.48 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Month 3 - Lead 2 - At Rest | 0.93 microvolts | Standard Deviation 0.34 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Month 3 - Lead 1 - Stress | 2.20 microvolts | Standard Deviation 0.56 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Month 3 - Lead 2 - Stress | 2.00 microvolts | Standard Deviation 0.53 |
| Experimental Group | Average Skin Sympathetic Nerve Activity (SKNA) | Month 3 - Lead 1 - Recovery | 1.42 microvolts | Standard Deviation 0.45 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 3 - Lead 2 - Stress | 1.60 microvolts | Standard Deviation 0.37 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Baseline - Lead 1 - At Rest | 1.12 microvolts | Standard Deviation 0.85 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Month 3 - Lead 2 - Recovery | 1.01 microvolts | Standard Deviation 0.13 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Baseline - Lead 2 - At Rest | 0.85 microvolts | Standard Deviation 0.11 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 1 - Lead 1 - Recovery | 1.13 microvolts | Standard Deviation 0.22 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Baseline - Lead 1 - Stress | 1.65 microvolts | Standard Deviation 0.32 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Month 3 - Lead 2 - At Rest | 0.82 microvolts | Standard Deviation 0.19 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Baseline - Lead 2 - Stress | 1.59 microvolts | Standard Deviation 0.45 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 1 - Lead 2 - Recovery | 0.94 microvolts | Standard Deviation 0.17 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Baseline - Lead 1 - Recovery | 1.27 microvolts | Standard Deviation 0.39 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 3 - Lead 1 - Recovery | 1.40 microvolts | Standard Deviation 0.86 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Baseline - Lead 2 - Recovery | 0.97 microvolts | Standard Deviation 0.26 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 2 - Lead 1 - At Rest | 0.89 microvolts | Standard Deviation 0.23 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Procedure - Lead 1 - At Rest | 1.06 microvolts | Standard Deviation 0.29 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Month 3 - Lead 2 - Stress | 1.49 microvolts | Standard Deviation 0.33 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Procedure - Lead 2 - At Rest | 1.00 microvolts | Standard Deviation 0.3 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 2 - Lead 2 - At Rest | 0.74 microvolts | Standard Deviation 0.22 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 1 - Lead 1 - At Rest | 0.95 microvolts | Standard Deviation 0.31 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 3 - Lead 2 - Recovery | 0.87 microvolts | Standard Deviation 0.19 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 1 - Lead 2 - At Rest | 0.85 microvolts | Standard Deviation 0.26 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 2 - Lead 1 - Stress | 1.65 microvolts | Standard Deviation 0.35 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 1 - Lead 1 - Stress | 1.55 microvolts | Standard Deviation 0.2 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Month 3 - Lead 1 - Stress | 1.86 microvolts | Standard Deviation 0.62 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 1 - Lead 2 - Stress | 1.43 microvolts | Standard Deviation 0.28 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 2 - Lead 2 - Stress | 1.41 microvolts | Standard Deviation 0.21 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 3 - Lead 2 - At Rest | 0.88 microvolts | Standard Deviation 0.33 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 2 - Lead 1 - Recovery | 1.15 microvolts | Standard Deviation 0.24 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Month 3 - Lead 1 - At Rest | 1.26 microvolts | Standard Deviation 0.64 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 2 - Lead 2 - Recovery | 0.84 microvolts | Standard Deviation 0.13 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 3 - Lead 1 - Stress | 1.69 microvolts | Standard Deviation 0.44 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Week 3 - Lead 1 - At Rest | 1.05 microvolts | Standard Deviation 0.39 |
| Control Group | Average Skin Sympathetic Nerve Activity (SKNA) | Month 3 - Lead 1 - Recovery | 1.57 microvolts | Standard Deviation 0.14 |
Secondary
Quality of Life - AFEQT
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.
Time frame: 3 months
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group | Quality of Life - AFEQT | Baseline AFEQT Global Score | 65.7 units on a scale | Standard Deviation 29.8 |
| Experimental Group | Quality of Life - AFEQT | Week 3 AFEQT Global Score | 61.6 units on a scale | Standard Deviation 28.4 |
| Experimental Group | Quality of Life - AFEQT | Week 12 AFEQT Global Score | 63.9 units on a scale | Standard Deviation 29.9 |
| Control Group | Quality of Life - AFEQT | Baseline AFEQT Global Score | 49.7 units on a scale | Standard Deviation 28.5 |
| Control Group | Quality of Life - AFEQT | Week 12 AFEQT Global Score | 71.7 units on a scale | Standard Deviation 20.7 |
| Control Group | Quality of Life - AFEQT | Week 3 AFEQT Global Score | 63.1 units on a scale | Standard Deviation 15.3 |
Secondary
Quality of Life - EQ-5D-5L
Improvement of quality of life as measured by the EQ-5D-5L
Time frame: 3 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group | Quality of Life - EQ-5D-5L | Baseline (total score) | 7.7 score on a scale | Standard Deviation 4.6 |
| Experimental Group | Quality of Life - EQ-5D-5L | Week 3 (total score) | 7.2 score on a scale | Standard Deviation 3 |
| Experimental Group | Quality of Life - EQ-5D-5L | Week 12 (total score) | 9.3 score on a scale | Standard Deviation 5.9 |
| Experimental Group | Quality of Life - EQ-5D-5L | Baseline (index value) | 0.8 score on a scale | Standard Deviation 0.4 |
| Experimental Group | Quality of Life - EQ-5D-5L | Week 3 (index value) | 0.8 score on a scale | Standard Deviation 0.2 |
| Experimental Group | Quality of Life - EQ-5D-5L | Week 12 (index value) | 0.7 score on a scale | Standard Deviation 0.5 |
| Control Group | Quality of Life - EQ-5D-5L | Baseline (index value) | 0.9 score on a scale | Standard Deviation 0.1 |
| Control Group | Quality of Life - EQ-5D-5L | Baseline (total score) | 6.3 score on a scale | Standard Deviation 0.8 |
| Control Group | Quality of Life - EQ-5D-5L | Week 12 (index value) | 0.9 score on a scale | Standard Deviation 0 |
| Control Group | Quality of Life - EQ-5D-5L | Week 3 (total score) | 6.2 score on a scale | Standard Deviation 0.8 |
| Control Group | Quality of Life - EQ-5D-5L | Week 3 (index value) | 0.9 score on a scale | Standard Deviation 0 |
| Control Group | Quality of Life - EQ-5D-5L | Week 12 (total score) | 6.0 score on a scale | Standard Deviation 0.7 |
Secondary
Ventricular Rate Control
Improved ventricular rate control during AF. AF-Free time was separated. Rate control during AF was categorized as the VR \<=110 BPM stage.
Time frame: 3 Months
Population: 1 patient who crossed over to the stimulation group did not have the 12-week visit
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Experimental Group | Ventricular Rate Control | Week 2 | VR ≤ 110 bpm | 2 Participants |
| Experimental Group | Ventricular Rate Control | 3 Months | AF-Free | 0 Participants |
| Experimental Group | Ventricular Rate Control | Week 2 | VR > 110 bpm | 4 Participants |
| Experimental Group | Ventricular Rate Control | Week 3 | AF-Free | 0 Participants |
| Experimental Group | Ventricular Rate Control | Week 3 | VR ≤ 110 bpm | 1 Participants |
| Experimental Group | Ventricular Rate Control | 3 Months | VR ≤ 110 bpm | 3 Participants |
| Experimental Group | Ventricular Rate Control | 3 Months | VR > 110 bpm | 3 Participants |
| Experimental Group | Ventricular Rate Control | Eligibility | AF-Free | 0 Participants |
| Experimental Group | Ventricular Rate Control | Eligibility | VR ≤ 110 bpm | 4 Participants |
| Experimental Group | Ventricular Rate Control | Eligibility | VR > 110 bpm | 2 Participants |
| Experimental Group | Ventricular Rate Control | Week 1 | AF-Free | 1 Participants |
| Experimental Group | Ventricular Rate Control | Week 1 | VR ≤ 110 bpm | 2 Participants |
| Experimental Group | Ventricular Rate Control | Week 1 | VR > 110 bpm | 3 Participants |
| Experimental Group | Ventricular Rate Control | Week 2 | AF-Free | 0 Participants |
| Experimental Group | Ventricular Rate Control | Week 3 | VR > 110 bpm | 5 Participants |
| Control Group | Ventricular Rate Control | Week 1 | AF-Free | 1 Participants |
| Control Group | Ventricular Rate Control | Week 3 | VR > 110 bpm | 0 Participants |
| Control Group | Ventricular Rate Control | Eligibility | AF-Free | 0 Participants |
| Control Group | Ventricular Rate Control | 3 Months | AF-Free | 1 Participants |
| Control Group | Ventricular Rate Control | Week 3 | VR ≤ 110 bpm | 4 Participants |
| Control Group | Ventricular Rate Control | Week 2 | VR ≤ 110 bpm | 4 Participants |
| Control Group | Ventricular Rate Control | Week 1 | VR > 110 bpm | 1 Participants |
| Control Group | Ventricular Rate Control | Week 2 | VR > 110 bpm | 1 Participants |
| Control Group | Ventricular Rate Control | Eligibility | VR ≤ 110 bpm | 4 Participants |
| Control Group | Ventricular Rate Control | Week 3 | AF-Free | 2 Participants |
| Control Group | Ventricular Rate Control | Week 1 | VR ≤ 110 bpm | 4 Participants |
| Control Group | Ventricular Rate Control | Eligibility | VR > 110 bpm | 2 Participants |
| Control Group | Ventricular Rate Control | 3 Months | VR ≤ 110 bpm | 3 Participants |
| Control Group | Ventricular Rate Control | Week 2 | AF-Free | 1 Participants |
| Control Group | Ventricular Rate Control | 3 Months | VR > 110 bpm | 1 Participants |