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The primary objective of this study is to estimate the proportion of hemodialysis patients experiencing clinically significant cardiac arrhythmias over a 6-month period using continuous cardiac monitoring with an implanted Medtronic Reveal Insertable Cardiac Monitor (ICM) device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REVEAL Insertable Cardiac Monitor (ICM) | Other | Monitoring of cardiac arrhythmic events and the relationship between such events and the characteristics. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REVEAL Insertable Cardiac Monitor (ICM) | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Significant Cardiac Arrhythmias Using Continuous Cardiac Monitoring Over a 6-month Period With an Implanted Medtronic Reveal ICM Device | Events defined as clinically significant for the objective include: episodes of ventricular tachycardia (VT) greater than or equal to 130 beats per minute (BPM), episodes of bradycardia indicated by a recorded heart rate less than or equal to 40 BPM, instances of asystole lasting at least three seconds, or any symptomatic event, indicated by patient use of the Reveal ICM Patient Assistant, where review of the stored ECG shows an arrhythmia considered clinically significant in the judgement of the study site cardiologist. | 6 months of dialysis data following Reveal ICM implant |
| Measure | Description | Time Frame |
|---|---|---|
| Collect the Number of Device and Procedure Related Adverse Events (AEs). | All procedure and device-related AEs will be recorded as they occur, and will be categorized according to seriousness, intensity, and relatedness to the device, device components, or implant procedure. | 6 months of dialysis data following Reveal ICM implant |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Augusta | Georgia | 30901 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36514397 | Derived | Soomro QH, Bansal N, Winkelmayer WC, Koplan BA, Costea AI, Roy-Chaudhury P, Tumlin JA, Kher V, Williamson DE, Pokhariyal S, McClure CK, Charytan DM; MiD Investigators. Association of Bradycardia and Asystole Episodes with Dialytic Parameters: An Analysis of the Monitoring in Dialysis (MiD) Study. Kidney360. 2022 Oct 11;3(11):1871-1880. doi: 10.34067/KID.0003142022. eCollection 2022 Nov 24. | |
| 30836948 |
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Subjects on dialysis 3 times per week
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| ID | Title | Description |
|---|---|---|
| FG000 | REVEAL Insertable Cardiac Monitor (ICM) | Patients implanted with Medtronic Reveal XT or LINQ Device |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Nature and Time of Health-related Events and Treatment Associated With ESRD and Other Conditions Occurring in the Implanted Patients |
Health-related events were recorded as they occurred. All health-related events were tabulated and summarized by type, time of occurrence (first 6 months and All Available Time (up to 2 years) and number of subjects affected. |
| up to 6 months and through study completion |
| Rate of Arrhythmias by Intradialytic Potassium Change and Volume Removed | The atrial arrhythmic events, ventricular arrhythmic events, and AF burden were tabulated and reported. Atrial arrhythmic episodes were distributed temporally over the inter- and intradialytic periods using the negative binomial mixed effect regression model as described above in the primary objective analysis. | 6 Month Follow-up |
| Collect and Quantify the Episodes of Arrhythmias | The atrial arrhythmic events, ventricular arrhythmic events, and AF burden will be tabulated and reported. | 6 months of dialysis data following Reveal ICM implant |
| Assess Whether the Morphology of ECG Recordings Captured by the Reveal ICM Device Correlate With Serum Electrolyte Levels Measured Just Before and Just After Dialysis Sessions. | The Reveal patient Assistant will be used to trigger memory storage of 7.5 minute ECG recordings in conjunction with serum electrolyte measurements taken before and after selected dialysis sessions. Measures of ECG morphology (e.g., QT interval, QT dispersion, QRS width, T-wave amplitude) will then be extracted from the recorded ECG data. The serum electrolyte data will also be included. | 6 months |
| Boston |
| Massachusetts |
| 02120 |
| United States |
| Cincinnati | Ohio | 45267 | United States |
| Chattanooga | Tennessee | 37408 | United States |
| Houston | Texas | 77030 | United States |
| Chennai | 600006 | India |
| Gurgaon | 122001 | India |
| Hyderabad | 500034 | India |
| New Delhi | 110070 | India |
| New Delhi | 110076 | India |
| Derived |
| Tumlin JA, Roy-Chaudhury P, Koplan BA, Costea AI, Kher V, Williamson D, Pokhariyal S, Charytan DM; MiD investigators and Committees. Relationship between dialytic parameters and reviewer confirmed arrhythmias in hemodialysis patients in the monitoring in dialysis study. BMC Nephrol. 2019 Mar 5;20(1):80. doi: 10.1186/s12882-019-1212-6. |
| COMPLETED |
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| NOT COMPLETED |
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Number of subjects who were eligible for implant after consent
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| ID | Title | Description |
|---|---|---|
| BG000 | REVEAL Insertable Cardiac Monitor (ICM) | Monitoring of cardiac arrhythmic events and the relationship between such events and the characteristics. REVEAL Insertable Cardiac Monitor (ICM) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Number of Participants With Clinically Significant Cardiac Arrhythmias Using Continuous Cardiac Monitoring Over a 6-month Period With an Implanted Medtronic Reveal ICM Device | Events defined as clinically significant for the objective include: episodes of ventricular tachycardia (VT) greater than or equal to 130 beats per minute (BPM), episodes of bradycardia indicated by a recorded heart rate less than or equal to 40 BPM, instances of asystole lasting at least three seconds, or any symptomatic event, indicated by patient use of the Reveal ICM Patient Assistant, where review of the stored ECG shows an arrhythmia considered clinically significant in the judgement of the study site cardiologist. | 81 subjects were enrolled in the study; however, only 66 subjects were implanted with the device. This accounts for the difference in analyzed numbers. | Posted | Number | participants | 6 months of dialysis data following Reveal ICM implant |
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| Secondary | Collect the Number of Device and Procedure Related Adverse Events (AEs). | All procedure and device-related AEs will be recorded as they occur, and will be categorized according to seriousness, intensity, and relatedness to the device, device components, or implant procedure. | Posted | Number | Events | 6 months of dialysis data following Reveal ICM implant |
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| Secondary | Nature and Time of Health-related Events and Treatment Associated With ESRD and Other Conditions Occurring in the Implanted Patients | Health-related events were recorded as they occurred. All health-related events were tabulated and summarized by type, time of occurrence (first 6 months and All Available Time (up to 2 years) and number of subjects affected. | Health-related events were recorded as they occurred. All health-related events were tabulated and summarized by type, time of occurrence, number of occurrences, and number of subjects affected. Summary statistics include events counts. | Posted | Number | number of events reported by | up to 6 months and through study completion |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Arrhythmias by Intradialytic Potassium Change and Volume Removed | The atrial arrhythmic events, ventricular arrhythmic events, and AF burden were tabulated and reported. Atrial arrhythmic episodes were distributed temporally over the inter- and intradialytic periods using the negative binomial mixed effect regression model as described above in the primary objective analysis. | Reviewer confirmed arrhythmia rate normalized per hour | Posted | Number | arrhythmic events | 6 Month Follow-up |
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| Secondary | Collect and Quantify the Episodes of Arrhythmias | The atrial arrhythmic events, ventricular arrhythmic events, and AF burden will be tabulated and reported. | Posted | Number | Arrhythmia Episodes | 6 months of dialysis data following Reveal ICM implant |
|
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| Secondary | Assess Whether the Morphology of ECG Recordings Captured by the Reveal ICM Device Correlate With Serum Electrolyte Levels Measured Just Before and Just After Dialysis Sessions. | The Reveal patient Assistant will be used to trigger memory storage of 7.5 minute ECG recordings in conjunction with serum electrolyte measurements taken before and after selected dialysis sessions. Measures of ECG morphology (e.g., QT interval, QT dispersion, QRS width, T-wave amplitude) will then be extracted from the recorded ECG data. The serum electrolyte data will also be included. | Posted | Median | Full Range | Correlation Coefficient | 6 months |
|
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Adverse events were collected through study completion, an average of 1 year.
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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 | REVEAL Insertable Cardiac Monitor (ICM) | Monitoring of cardiac arrhythmic events and the relationship between such events and the characteristics. REVEAL Insertable Cardiac Monitor (ICM) | 3 | 81 | 28 | 81 | 8 | 81 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Sinus arrest | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Graft dysfunction | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Graft thrombosis | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Spinal cord injury cervical | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Troponin increased | Investigations | MedDRA (10.0) | Systematic Assessment |
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| Fluid overload | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
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| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Arterial bypass operation | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
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| Renal transplant | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
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| Accelerated hypertension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
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| Aortic dissection | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suture related complication | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
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| Implant site pain | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Implant site haematoma | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Wound infection staphylococcal | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Impaired healing | General disorders | MedDRA (10.0) | Systematic Assessment |
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The intent of the project is to develop a foundation, which is scientifically based, to generate hypotheses resulting from data collected during theobservational study. Further research may be investigated based on the outcome of this small study.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| RCS Sr. Director of Medical Affairs | Medtronic, plc | 763-505-4566 | amy.denise.roettger@medtronic.com |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Black or African American |
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| White or Caucasian |
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| Title | Measurements |
|---|---|
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| CSA Subtype (Asystole) |
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| CSA Subtype (Patient Marked Events) |
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| Title | Denominators | Categories |
|---|
| Procedure Releated AEs |
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| Device Related AEs |
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| Not Related |
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| Unknown |
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| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Overall Reviewer Confirmed Arrhythmias |
| |||||
| Atrial Fibrillation Arrhythmia > 6 min |
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| Ventricular Arrhythmia |
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| Bradycardia |
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| Asystole |
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| Sinus Tachycardia |
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| Patient Marked |
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