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Using Electrical Nerve Stimulation to Control Atrial Fibrillation

Information provided by:

Cedars-Sinai Medical Center

Last updated:

11/21/2022

Trial identifier:

NCT04529941

Disclaimer

Study Description

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.

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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:
Time-dependent reduction of AF burden
Effects of ScNS on ventricular rate control during AF
Reduction of SKNA
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.
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Official Title

Glossary term:

Title
The official title of a protocol used to identify a clinical study or a short title written in language intended for the lay public.

Using Electrical Nerve Stimulation to Control Atrial Fibrillation

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Type of Study

Glossary term:

Study Type
Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access. Interventional studies (clinical trials): A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions. Observational studies: A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific intervention/treatment. A patient registry is a type of observational study. Expanded access: A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.

Interventional

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Enrollment (Anticipated)

Glossary term:

Enrollment
The number of participants in a clinical study. The "estimated" enrollment is the target number of participants that the researchers need for the study.

30

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Phase

Glossary term:

Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0): Exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies). Phase 1: Clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants. Phase 2: Clinical trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied. Phase 3: Clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants. Phase 4: Clinical trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug's safety, efficacy, or optimal use. Not Applicable: Trials without FDA-defined phases, including trials of devices or behavioral interventions.

Not Applicable

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Other Study ID Numbers

Glossary term:

Other study IDs
Identifiers or ID numbers other than the NCT number that are assigned to a clinicalstudy by the study's sponsor, funders, or others. These numbers may include unique identifiers from othertrial registries and National Institutes of Health grant numbers.

STUDY00000581

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Intervention / Treatment

Glossary term:

Intervention/treatment
A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Device: Device Implant with Active Treatment
Device: Device Implant without Active Treatment

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Study Start (Actual)

Glossary term:

Study start date
The actual date on which the first participant was enrolled in a clinical study. The "estimated" study start date is the date that the researchers think will be the study start date.

Nov 24, 2021

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Primary Completion (Anticipated)

Glossary term:

Primary completion date
The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "estimated" primary completion date is the date that the researchers think will be the primary completion date for the study.

Jul 01, 2023

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Study Completion (Anticipated)

Glossary term:

Study completion date
The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "estimated" study completion date is the date that the researchers think will be the study completion date.

Jul 01, 2023

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First Submitted Date

Glossary term:

First submitted
The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).

Aug 25, 2020

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First Submitted that Met QC Criteria

Glossary term:

First submitted that met QC criteria
The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.

Aug 25, 2020

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First Posted (Actual)

Glossary term:

First posted
The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.

Aug 28, 2020

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Last Update Submitted that Met MQ Criteria

Glossary term:

Last update submitted that met QC criteria
The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.

Nov 16, 2022

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Last Update Posted (Actual)

Glossary term:

Last update posted
The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date)and the last update posted date.

Nov 21, 2022

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Other important Dates

Contacts and Locations

Locations (1)

Contacts and Locations

Locations (1)

Contacts

Study Contact

Glossary term:

Contact
The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Name: Peng-Sheng Chen, MD

Phone Number: 310-423-6084

Email: Chenp@cshs.org

Name: Tracey S Early, BS, MA

Phone Number: 310.423.1231

Email: tracey.early@cshs.org


Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments. For general information about clinical research, read Guides to Clinical Trials.

Eligibility Criteria

Ages Eligible for Study:

Glossary term:

Age
A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups: The age groups are: Child (birth–17) Adult (18–64) Older adult (65+)

18 Years - 75 Years

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Accepts Healthy Volunteers:

Glossary term:

Accepts Healthy Volunteers
A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study.

No

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Sexes Eligible for Study:

Glossary term:

Sex
A type of eligibility criteria that indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility.

All

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Description:

Inclusion Criteria:

  • 18 to 75 years of age
  • Symptomatic AF.
  • Symptomatic 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, nylon or latex
  • Pregnant women

Study Plan

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

How is the study designed?

Design Details:
Primary Purpose:

Treatment

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Allocation:

Randomized

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Interventional Model:

Parallel Assignment

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Interventional 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.

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Number of Arms:

2

Arms and Interventions:

Participant Group / Arm

Glossary term:

Arm
A group or subgroup of participants in a clinical trial that receives a specificintervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Glossary term:

Intervention/treatment
A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Sham Comparator: Control Group

Does not receive therapy

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Sham Comparator: Control Group

Does not receive therapy

Device: Device Implant without Active Treatment

No device output for 2 weeks

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Device: Device Implant without Active Treatment

No device output for 2 weeks

Experimental: Experimental Group

Will receive stimulation ScNS at 3.5mA output

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Experimental: Experimental Group

Will receive stimulation ScNS at 3.5mA output

Device: Device Implant with Active Treatment

ScNS at 3.5mA output for 2 weeks

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Device: Device Implant with Active Treatment

ScNS at 3.5mA output for 2 weeks

What is the study measuring?

Primary Outcome Measures

Glossary term:

Primary outcome measure
In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.

Outcome Measure

AF Burden

Measure Description

Lower AF burden from Baseline in the active treatment group than the control group

Timeframe

2 weeks

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Outcome Measure
Measure Description
Timeframe

AF Burden

Lower AF burden from Baseline in the active treatment group than the control group

2 weeks

Secondary Outcome Measures

Glossary term:

Secondary outcome measure
In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.

Outcome Measure

Ventricular Rate Control

Measure Description

Improved ventricular rate control during AF

Timeframe

2 weeks

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Outcome Measure
Measure Description
Timeframe

Ventricular Rate Control

Improved ventricular rate control during AF

2 weeks


Sponsor and Collaborators

The Sponsor of a study is the organization or person that is conducting the study. They may provide resources needed to do the investigation.

Sponsor:

Glossary term:

Sponsor
The organization or person who initiates the study and who has authority and control over the study.
  1. Cedars-Sinai Medical Center

Investigators and Collaborators

Investigators and Collaborators

Investigators:

Glossary term:

Investigator
A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
    Central Contacts:
  • Peng-Sheng Chen, MD
  • Tracey S Early, BS, MA
Overall Officials:
  • Peng-Sheng Chen, MD
Collaborators:

Glossary term:

Collaborator
An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.

More Information

Publications
Publications of Study Results
General Publications

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Publications Automatically Indexed to this Study by ClinicalTrials.Gov Identifier (NCT Number

No publications available

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