Non-Invasive Median Nerve Stimulation to Attenuate Atrial Tachyarrhythmias After Catheter Ablation for Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- AF/AFL occurrence
研究概览
简要总结
Determine the role of vagal/median nerve stimulation using the CardiaCare RR2 home care wearable neuromodulation system on suppressing atrial arrhythmias and related symptoms in patients who have undergone AF ablation. The study population will be comprised of adults (age ≥18 yrs.) who have undergone AF ablation for paroxysmal or persistent AF.
The study will assess the ability of neuromodulation, using the CardiaCare RR2 home care wearable, to suppress the following:
- early (0-2 months) post-ablation arrhythmias that occur in the immediate post-ablation time period
- AF/AT/AFL recurrences between months 2-6 post-ablation.This is a prospective, controlled, double-blind, randomized trial. The first 15 patients will not be randomized and will receive the active median/vagal stimulation only (open label).
The Study will be conducted in up to 1 clinical site in the United States. This study will have 1:1 randomization (active median/vagal stimulation vs sham). The study has been given NSR designation from FDA--NO IDE.
详细描述
Study will include continuous ECG assessment at 2 (0 for the first 15 patients, open label), 6 and 22 weeks from enrollment for 2 weeks (for 4 weeks at the first measurement for the first 15 patients, open label) and at least daily single lead ECG assessments throughout the follow up period. The ECG's generated can be viewed by physicians only to assess the frequency of RR2 treatments and will not be used to alter any other aspects of standard of care, including medical management, which will continue according to standard of care throughout the study. Patients and investigators will be blinded during the trial. Patients with paroxysmal or persistent AF undergoing AF ablation will be recruited post ablation procedure during hospitalization. During screening/baseline visit, eligible patients will be randomized to either an active treatment or a sham group (1:1 accordingly). The first 15 eligible patients will not be randomized and will receive the active median/vagal stimulation only (open label).
Patients will receive training on the RR2 for home-care use, by study personnel either in person or via a video conference meeting. An instructional video will also be available for users. Patients will be ordered to measure at home, 2 min ECG measurements with the RR2 system, two times a day throughout the study and when feeling symptoms suspected related to AF (AF/AT/PAC).
In addition, Patients will be instructed to perform Neuromodulation sessions with the RR2 home care device. Once a day for the first 2 weeks followed by three times per week for the remaining duration of the study. Additional treatments, up to once daily, will be added during this period in case the patient feels symptom, verified on single lead ECG and site staff.
Treatments will be conducted for a period of 6 months. During the study, the patients will continue to take Standard of care medication. Medications will be recorded throughout the study.
Patient Diary will be dispensed and or APP diary questioners will be used by the subject in order to document symptoms suspected as related to arrhythmia events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Patient and investigator are blinded, as is the statistician
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ages ≥18 years
- •Patients planned to undergo or undergoing AF ablation for paroxysmal or persistent AF and able to be randomized within 48 hours of the ablation procedure.
- •Ability and willingness to sign an informed consent form.
- •Ability and willingness to use CardiaCare RR2 device, continuous ECG monitoring, and has an available SmartPhone.
排除标准
- •Rheumatic heart disease
- •Extensive atrial disease (* some patients may be determined to be screen failures following the ablation procedure).
- •Moderate to severe mitral stenosis or history of mitral valve replacement
- •Pacemaker or CRTD or any implanted electrical stimulating device
- •Unilateral or bilateral vagotomy
- •Peripheral neuropathy affecting the tested upper extremity.
- •Severe heart failure (New York Heart Association Class III or IV) within 90 days.
- •Recent (within 90 days) stroke or transient ischemic attack.
- •Recent (within 90 days) myocardial infarction.
- •Pregnancy or breast feeding.
- •Life expectancy <1 year for any medical condition
- •Currently enrolled in another study that would interfere with this study
- •Unsuitable for participating in the study according to attending physician
研究组 & 干预措施
Participants with CardiaCare RR2
Participants undergoing Neuromodulation Sessions (mNVS) and Active Median/Vagal Stimulation. Patients will receive training on the RR2 for home-care use, by study personnel either in person or via a video conference meeting. An instructional video will also be available for users.
干预措施: CardiaCare RR2 (Device)
Participants with Sham Device
Sham device will be dispensed, which will create a sensation but not provide therapy
干预措施: Sham Device (Device)
结局指标
主要结局
AF/AFL occurrence
时间窗: at 2-months and 6-months post-ablation procedure
Burden of AF/AFL (defines as 30 seconds or longer) during the 2-months and 6-months period after ablation measured using ECG-patch monitoring and daily RR2 single lead ECG.
次要结局
- Time to first Atrial tachycardia (AT) or Atrial Fibrillation (AF) recurrence(6 months post-ablation)
- Number of arrythmia occurrences(2-month and 6-month post-ablation procedure)
- Number of Atrial Arrythmia Symptoms(6-month post-ablation procedure)
- Quality of Life measured using The European Heart Rhythm Association (EHRA) score(Baseline, 2-months, and 6-months)
- Change in PAC/AT/AFL before and after treatment with RR2(Baseline and 6-month post-ablation)
- Quality of Life measured using Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Score(Baseline, 2-months, and 6-months)
- Change in Heart Rate Variability (HRV)(Baseline and 6-month post-ablation)
- Number of ER Visits(6-month post-ablation)
- Number of Hospitalizations(6-month post-ablation)
- Number of Cardioversions(6-month post-ablation)
- Number of Ablation Re-Do's(6-month post-ablation)
- Time to first Atrial tachycardia (AT) or Atrial Fibrillation (AF) recurrence(2-month and 6-month post-ablation procedure)
研究者
Vivek Reddy
Director EP Service
Icahn School of Medicine at Mount Sinai