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| Name | Class |
|---|---|
| Parasym Ltd. | INDUSTRY |
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Patients undergoing cardiac surgery, specifically a coronary artery bypass graft and/or heart valve replacement surgery, are at a higher risk for post-procedure atrial fibrillation (AF). AF is a condition in which the upper chambers of the heart do not contract normally and results in an irregular heartbeat. Recent studies have shown that tragus stimulation decreases the likelihood of AF in animals and humans. It has also been shown to reduce inflammation which may be related to post-procedure AF. Tragus stimulation involves stimulating a part of the outer ear, called the tragus, by sending a microcurrent through a small alligator clip. It is believed that tragus stimulation can affect the nervous system, which may reduce heart rate and lead to prevention of AF. The purpose of this study is to determine whether tragus stimulation in subjects undergoing cardiac surgery will lead to shorter occurrences, or even prevention, of AF.
This was a single-blind study where patients were randomized tragus stimulation versus sham procedure and remained blinded to their treatment allocation. Both treatment options utilized similar equipment, namely the use of alligator clips which will be placed on the tragus and earlobe of the right ear for patients.
Prior to cardiac surgery, the discomfort threshold of both left and right tragus stimulation was determined for all participating patients. Intermittent electrode signals, or microcurrents, were delivered at 20 Hz with100 µsec pulse width with variable microampere (mA) output. The discomfort threshold was defined as the stimulation intensity in mA at which point patients experience discomfort. The stimulation intensity used in the study was set below the sensation and discomfort threshold. The clip was placed on the patient's ear at the end of surgery. Stimulation then continued, one ear alternating with the other, every 4 hours for a total of 48 hours. If the patient showed any sign of discomfort from stimulation, the intensity of stimulation was reduced to a level at which signs of discomfort disappears.
Follow-up was performed with a 14-day event monitor at the time of discharge, as clinically indicated. Echocardiography were assessed prior to study initiation and when clinically available in follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Group | No Intervention | At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, but the Parasym was not turned on and the subject did not receive any stimulation. The clip was switched to the other ear every 4 hours for a total of 48 hours. | |
| Stimulation Group | Experimental | At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, and the subject received continuous stimulation for 48 hours. The clip was switched to the other ear every 4 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parasym | Device | Tragus stimulation was done using the Parasym device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to the First Episode of Atrial Fibrillation (AF) >30 Seconds | Time to the first episode of atrial fibrillation (AF) that was greater than 30 seconds in patients who had AF. This was assessed on the review of patient chart and inpatient telemetry. | From end of surgery to end of hospitalization, up to 1 month. |
| Number of Participants Hospitalized for >5 Days | Number of participants with an overall length of hospitalization greater than five days. | From end of surgery to end of hospitalization, up to 1 month. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Atrial Fibrillation (AF) Burden | The total number of hours of atrial fibrillation (AF) burden as an inpatient. | From end of surgery to end of hospitalization, up to 1 month. |
| Number of Participants With Rate Control Medications Used for AF |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gaurav A. Upadhyay, MD | University of Chicago | Principal Investigator |
| Roderick Tung, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | United States |
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Subjects were recruited from the University of Chicago Medical Center
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| ID | Title | Description |
|---|---|---|
| FG000 | Stimulation Group | At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, and the subject received continuous stimulation for 48 hours. The clip was switched to the other ear every 4 hours. Parasym: Tragus stimulation has been done using the Parasym device. |
| FG001 | Sham Group | At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, but the Parasym was not turned on and the subject did not receive any stimulation. The clip was switched to the other ear every 4 hours for a total of 48 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stimulation Group | At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, and the subject received continuous stimulation for 48 hours. The clip was switched to the other ear every 4 hours. Parasym: Tragus stimulation was done using the Parasym device. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to the First Episode of Atrial Fibrillation (AF) >30 Seconds | Time to the first episode of atrial fibrillation (AF) that was greater than 30 seconds in patients who had AF. This was assessed on the review of patient chart and inpatient telemetry. | Posted | Median | Inter-Quartile Range | hours | From end of surgery to end of hospitalization, up to 1 month. |
|
From the end of the surgery to the end of hospitalization, up to 1 month.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stimulation Group | At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, and the subject received continuous stimulation for 48 hours. The clip was switched to the other ear every 4 hours. Parasym: Tragus stimulation was done using the Parasym device. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke or Transient Ischemic Attack (TIA) | Vascular disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin abrasion | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Discomfort from device with skin redness was noted |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gaurav Upadhyay | Univerisity of Chicago Medicine | 773-702-9461 | gupadhyay@medicine.bsd.uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 11, 2019 | Mar 4, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Number of participants that the management of their postoperative atrial fibrillation (AF) utilized the use of rate-controlling medications such as beta-blockers, calcium-channel blockers, or the use of digoxin.
| From end of surgery to end of hospitalization, up to 1 month. |
| Number of Participants With Antiarrhythmic Used to Treat AF | Number of participants that antiarrhythmic was use to treat atrial fibrillation (i.e., use of amiodarone) | From end of surgery to end of hospitalization, up to 1 month. |
| Number of Participants With Inotropes Used for Blood Pressure Support During AF | The number of participants who management of their postoperative atrial fibrillation (AF) required the use of inotropic vasoactive or pressor medications for blood pressure (BP) support | From end of surgery to end of hospitalization, up to 1 month. |
| Number of Participants With Stroke or Transient Ischemic Attack (TIA) | The number of participants who suffered from a cerebral vascular accident (CVA) or transient ischemic attacks (TIA) for any cause during hospitalization was recorded. | From end of surgery to end of hospitalization, up to 1 month. |
| All-cause Mortality | Number of participants who suffered from mortality due to any cause during the inpatient period | From end of surgery to end of hospitalization, up to 1 month. |
| Sham Group |
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, but the Parasym was not turned on, and the subject did not receive any stimulation. The clip was switched to the other ear every 4 hours for a total of 48 hours. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Height(cm) | Median | Inter-Quartile Range | cm |
|
| Weight(kg) | Median | Inter-Quartile Range | kg |
|
| Body Mass Index | Median | Inter-Quartile Range | kg/m^2 |
|
| NYHA Class | Heart failure condition were classified according to New York Heart Association (NYHA) functional classification system and based on clinical assessments at the time of enrollment. Lower NYHA class is associated with less symptomatic heart failure, i.e., Class I: no limitations in physical activity; Class II: Patients are comfortable at rest but ordinary physical activity results in symptoms; Class III: Less than ordinary physical activity result in symptoms; Class IV: unable to carry out any physical activity without discomfort. | Count of Participants | Participants |
|
| Diabetes Mellitus | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| History of stroke or transient ischemic attack | Count of Participants | Participants |
|
| Peripheral arterial disease | Count of Participants | Participants |
|
| Creatinine | Median | Inter-Quartile Range | micromoles/L |
|
| Chronic kidney disease | Count of Participants | Participants |
|
| End-stage renal disease | Count of Participants | Participants |
|
| Beta-blocker | Count of Participants | Participants |
|
| Calcium channel blocker | Count of Participants | Participants |
|
| Angiotensin converting enzyme inhibition or receptor blockade | Count of Participants | Participants |
|
| Aldosterone blockade | Count of Participants | Participants |
|
| Digoxin | Count of Participants | Participants |
|
| Totally-endoscopic coronary artery bypass (TECAB) | Count of Participants | Participants |
|
| Coronary artery bypass graft surgery (CABG) | Count of Participants | Participants |
|
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, but the Parasym was not turned on and the subject did not receive any stimulation. The clip has been switched to the other ear every 4 hours for a total of 48 hours.
|
|
|
| Primary | Number of Participants Hospitalized for >5 Days | Number of participants with an overall length of hospitalization greater than five days. | Posted | Count of Participants | Participants | From end of surgery to end of hospitalization, up to 1 month. |
|
|
|
|
| Secondary | Overall Atrial Fibrillation (AF) Burden | The total number of hours of atrial fibrillation (AF) burden as an inpatient. | Posted | Median | Inter-Quartile Range | hours | From end of surgery to end of hospitalization, up to 1 month. |
|
|
|
|
| Secondary | Number of Participants With Rate Control Medications Used for AF | Number of participants that the management of their postoperative atrial fibrillation (AF) utilized the use of rate-controlling medications such as beta-blockers, calcium-channel blockers, or the use of digoxin. | Posted | Count of Participants | Participants | From end of surgery to end of hospitalization, up to 1 month. |
|
|
|
|
| Secondary | Number of Participants With Antiarrhythmic Used to Treat AF | Number of participants that antiarrhythmic was use to treat atrial fibrillation (i.e., use of amiodarone) | Posted | Count of Participants | Participants | From end of surgery to end of hospitalization, up to 1 month. |
|
|
|
|
| Secondary | Number of Participants With Inotropes Used for Blood Pressure Support During AF | The number of participants who management of their postoperative atrial fibrillation (AF) required the use of inotropic vasoactive or pressor medications for blood pressure (BP) support | Posted | Count of Participants | Participants | From end of surgery to end of hospitalization, up to 1 month. |
|
|
|
|
| Secondary | Number of Participants With Stroke or Transient Ischemic Attack (TIA) | The number of participants who suffered from a cerebral vascular accident (CVA) or transient ischemic attacks (TIA) for any cause during hospitalization was recorded. | Posted | Count of Participants | Participants | From end of surgery to end of hospitalization, up to 1 month. |
|
|
|
|
| Secondary | All-cause Mortality | Number of participants who suffered from mortality due to any cause during the inpatient period | Posted | Count of Participants | Participants | From end of surgery to end of hospitalization, up to 1 month. |
|
|
|
|
| 3 |
| 40 |
| 1 |
| 40 |
| 0 |
| 40 |
| EG001 | Sham Group | At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, but the Parasym was not turned on and the subject did not receive any stimulation. The clip has been switched to the other ear every 4 hours for a total of 48 hours. | 0 | 41 | 1 | 41 | 1 | 41 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |