Trial Outcomes & Findings for Monitoring in Dialysis -- a Prospective, Multi-center, Single-arm, Non-randomized, Observational Study in Patients Who Are Undergoing Hemodialysis. (NCT NCT01779856)

Last Updated: 2021-02-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

81 participants

Primary outcome timeframe

6 months of dialysis data following Reveal ICM implant

Results posted on

2021-02-15

Participant Flow

Subjects on dialysis 3 times per week

Participant milestones

Participant milestones
Measure	REVEAL Insertable Cardiac Monitor (ICM) Patients implanted with Medtronic Reveal XT or LINQ Device
Overall Study STARTED	81
Overall Study COMPLETED	57
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Reasons for withdrawal
Measure	REVEAL Insertable Cardiac Monitor (ICM) Patients implanted with Medtronic Reveal XT or LINQ Device
Overall Study Withdrawal by Subject	15
Overall Study Death	3
Overall Study Physician Decision	1
Overall Study Inclusion/Exclusion Not Met	2
Overall Study Delays in scheduling implant	1
Overall Study Subject ineligible for Implant	2

Baseline Characteristics

Monitoring in Dialysis -- a Prospective, Multi-center, Single-arm, Non-randomized, Observational Study in Patients Who Are Undergoing Hemodialysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	REVEAL Insertable Cardiac Monitor (ICM) n=75 Participants Monitoring of cardiac arrhythmic events and the relationship between such events and the characteristics. REVEAL Insertable Cardiac Monitor (ICM)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=5 Participants
Age, Categorical >=65 years	26 Participants n=5 Participants
Age, Continuous	56.3 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	28 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	39 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	7 Participants n=5 Participants
Region of Enrollment United States	47 participants n=5 Participants
Region of Enrollment India	28 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months of dialysis data following Reveal ICM implant

Population: 81 subjects were enrolled in the study; however, only 66 subjects were implanted with the device. This accounts for the difference in analyzed numbers.

Outcome measures

Outcome measures
Measure	REVEAL Insertable Cardiac Monitor (ICM) n=66 Participants Patients implanted with Medtronic Reveal XT or LINQ Device	All Available Time (up to 2 Years) Number of health care utilizations, by category, that occurred within the course of the study.	Volume Removed 4.3 (L) volume removed during dialysis
Number of Participants With Clinically Significant Cardiac Arrhythmias Using Continuous Cardiac Monitoring Over a 6-month Period With an Implanted Medtronic Reveal ICM Device All CSA	44 participants	—	—
Number of Participants With Clinically Significant Cardiac Arrhythmias Using Continuous Cardiac Monitoring Over a 6-month Period With an Implanted Medtronic Reveal ICM Device CSA Subtype (VT)	1 participants	—	—
Number of Participants With Clinically Significant Cardiac Arrhythmias Using Continuous Cardiac Monitoring Over a 6-month Period With an Implanted Medtronic Reveal ICM Device CSA Subtype (Bradycardia)	13 participants	—	—
Number of Participants With Clinically Significant Cardiac Arrhythmias Using Continuous Cardiac Monitoring Over a 6-month Period With an Implanted Medtronic Reveal ICM Device CSA Subtype (Asystole)	6 participants	—	—
Number of Participants With Clinically Significant Cardiac Arrhythmias Using Continuous Cardiac Monitoring Over a 6-month Period With an Implanted Medtronic Reveal ICM Device CSA Subtype (Patient Marked Events)	38 participants	—	—

SECONDARY outcome

Timeframe: 6 months of dialysis data following Reveal ICM implant

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.

Outcome measures

Outcome measures
Measure	REVEAL Insertable Cardiac Monitor (ICM) n=81 Participants Patients implanted with Medtronic Reveal XT or LINQ Device	All Available Time (up to 2 Years) Number of health care utilizations, by category, that occurred within the course of the study.	Volume Removed 4.3 (L) volume removed during dialysis
Collect the Number of Device and Procedure Related Adverse Events (AEs). Procedure Releated AEs	3 Events	—	—
Collect the Number of Device and Procedure Related Adverse Events (AEs). Device Related AEs	2 Events	—	—
Collect the Number of Device and Procedure Related Adverse Events (AEs). Not Related	50 Events	—	—
Collect the Number of Device and Procedure Related Adverse Events (AEs). Unknown	2 Events	—	—

SECONDARY outcome

Timeframe: up to 6 months and through study completion

Population: 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.

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.

Outcome measures

Outcome measures
Measure	REVEAL Insertable Cardiac Monitor (ICM) n=81 Participants Patients implanted with Medtronic Reveal XT or LINQ Device	All Available Time (up to 2 Years) n=81 Participants Number of health care utilizations, by category, that occurred within the course of the study.	Volume Removed 4.3 (L) volume removed during dialysis
Nature and Time of Health-related Events and Treatment Associated With ESRD and Other Conditions Occurring in the Implanted Patients Inpatient : number of events reports	33 number of events reported by	44 number of events reported by	—
Nature and Time of Health-related Events and Treatment Associated With ESRD and Other Conditions Occurring in the Implanted Patients Out-Patient : number of events reports	14 number of events reported by	15 number of events reported by	—
Nature and Time of Health-related Events and Treatment Associated With ESRD and Other Conditions Occurring in the Implanted Patients Emergency Department : number of events reports	35 number of events reported by	42 number of events reported by	—
Nature and Time of Health-related Events and Treatment Associated With ESRD and Other Conditions Occurring in the Implanted Patients Urgent Care : number of events reports	57 number of events reported by	73 number of events reported by	—

SECONDARY outcome

Timeframe: 6 Month Follow-up

Population: Reviewer confirmed arrhythmia rate normalized per hour

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.

Outcome measures

Outcome measures
Measure	REVEAL Insertable Cardiac Monitor (ICM) n=66 Participants Patients implanted with Medtronic Reveal XT or LINQ Device	All Available Time (up to 2 Years) n=66 Participants Number of health care utilizations, by category, that occurred within the course of the study.	Volume Removed 4.3 n=66 Participants (L) volume removed during dialysis
Rate of Arrhythmias by Intradialytic Potassium Change and Volume Removed 0 Potassium Change	0.013 arrhythmic events	0.02 arrhythmic events	0.007 arrhythmic events
Rate of Arrhythmias by Intradialytic Potassium Change and Volume Removed -1 Potassium Change	0.014 arrhythmic events	0.015 arrhythmic events	0.016 arrhythmic events
Rate of Arrhythmias by Intradialytic Potassium Change and Volume Removed -2 Potassium Change	0.015 arrhythmic events	0.023 arrhythmic events	0.03 arrhythmic events

SECONDARY outcome

Timeframe: 6 months of dialysis data following Reveal ICM implant

The atrial arrhythmic events, ventricular arrhythmic events, and AF burden will be tabulated and reported.

Outcome measures

Outcome measures
Measure	REVEAL Insertable Cardiac Monitor (ICM) n=66 Participants Patients implanted with Medtronic Reveal XT or LINQ Device	All Available Time (up to 2 Years) Number of health care utilizations, by category, that occurred within the course of the study.	Volume Removed 4.3 (L) volume removed during dialysis
Collect and Quantify the Episodes of Arrhythmias Bradycardia	17 Arrhythmia Episodes	—	—
Collect and Quantify the Episodes of Arrhythmias Overall Reviewer Confirmed Arrhythmias	64 Arrhythmia Episodes	—	—
Collect and Quantify the Episodes of Arrhythmias Atrial Fibrillation Arrhythmia > 6 min	60 Arrhythmia Episodes	—	—
Collect and Quantify the Episodes of Arrhythmias Ventricular Arrhythmia	51 Arrhythmia Episodes	—	—
Collect and Quantify the Episodes of Arrhythmias Asystole	7 Arrhythmia Episodes	—	—
Collect and Quantify the Episodes of Arrhythmias Sinus Tachycardia	53 Arrhythmia Episodes	—	—
Collect and Quantify the Episodes of Arrhythmias Patient Marked	38 Arrhythmia Episodes	—	—

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure	REVEAL Insertable Cardiac Monitor (ICM) n=35 Participants Patients implanted with Medtronic Reveal XT or LINQ Device	All Available Time (up to 2 Years) Number of health care utilizations, by category, that occurred within the course of the study.	Volume Removed 4.3 (L) volume removed during dialysis
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. R Value: R Wave Amplitude vs Potassium	-0.35 Correlation Coefficient Interval -0.86 to 0.67	—	—
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. R Value: R Wave Amplitude vs Magnesium	-0.33 Correlation Coefficient Interval -0.83 to 0.48	—	—
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. R Value: R Wave Amplitude vs. Phosphorus	-0.45 Correlation Coefficient Interval -0.84 to 0.68	—	—

Adverse Events

REVEAL Insertable Cardiac Monitor (ICM)

Serious events: 28 serious events

Other events: 8 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	REVEAL Insertable Cardiac Monitor (ICM) n=81 participants at risk Monitoring of cardiac arrhythmic events and the relationship between such events and the characteristics. REVEAL Insertable Cardiac Monitor (ICM)
Blood and lymphatic system disorders Anaemia	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.
Cardiac disorders Acute myocardial infarction	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.
Cardiac disorders Angina pectoris	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.
Cardiac disorders Atrial fibrillation	2.5% 2/81 • Number of events 3 • Adverse events were collected through study completion, an average of 1 year.
Cardiac disorders Myocardial ischaemia	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.
Cardiac disorders Sick sinus syndrome	3.7% 3/81 • Number of events 3 • Adverse events were collected through study completion, an average of 1 year.
Cardiac disorders Sinus arrest	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.
Cardiac disorders Tachycardia	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.
Gastrointestinal disorders Abdominal pain	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.
Gastrointestinal disorders Colitis	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.2% 1/81 • Number of events 2 • Adverse events were collected through study completion, an average of 1 year.
Gastrointestinal disorders Pancreatitis	1.2% 1/81 • Number of events 3 • Adverse events were collected through study completion, an average of 1 year.
General disorders Non-cardiac chest pain	2.5% 2/81 • Number of events 2 • Adverse events were collected through study completion, an average of 1 year.
Infections and infestations Pneumonia	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.
Infections and infestations Pneumonia bacterial	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.
Infections and infestations Tuberculosis	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.
Injury, poisoning and procedural complications Graft dysfunction	2.5% 2/81 • Number of events 2 • Adverse events were collected through study completion, an average of 1 year.
Injury, poisoning and procedural complications Graft thrombosis	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.
Injury, poisoning and procedural complications Humerus fracture	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.
Injury, poisoning and procedural complications Spinal cord injury cervical	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.
Investigations Troponin increased	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.
Metabolism and nutrition disorders Fluid overload	4.9% 4/81 • Number of events 5 • Adverse events were collected through study completion, an average of 1 year.
Metabolism and nutrition disorders Hyperkalaemia	2.5% 2/81 • Number of events 2 • Adverse events were collected through study completion, an average of 1 year.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.
Nervous system disorders Cerebral haemorrhage	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.
Surgical and medical procedures Arterial bypass operation	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.
Surgical and medical procedures Renal transplant	2.5% 2/81 • Number of events 2 • Adverse events were collected through study completion, an average of 1 year.
Vascular disorders Accelerated hypertension	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.
Vascular disorders Haematoma	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.
Musculoskeletal and connective tissue disorders Aortic dissection	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.

Other adverse events

Other adverse events
Measure	REVEAL Insertable Cardiac Monitor (ICM) n=81 participants at risk Monitoring of cardiac arrhythmic events and the relationship between such events and the characteristics. REVEAL Insertable Cardiac Monitor (ICM)
Surgical and medical procedures Suture related complication	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.
General disorders Implant site pain	2.5% 2/81 • Number of events 2 • Adverse events were collected through study completion, an average of 1 year.
General disorders Implant site haematoma	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.
Infections and infestations Wound infection staphylococcal	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	1.2% 1/81 • Number of events 1 • Adverse events were collected through study completion, an average of 1 year.
General disorders Impaired healing	2.5% 2/81 • Number of events 2 • Adverse events were collected through study completion, an average of 1 year.

Additional Information

RCS Sr. Director of Medical Affairs

Medtronic, plc

Phone: 763-505-4566

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place