Trial Outcomes & Findings for Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System (NCT NCT01965899)

NCT ID: NCT01965899

Last Updated: 2016-09-23

Results Overview

To assess the percentage of successful automatic wireless transmissions from the system within the first 30 days of implant.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 151 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2016-09-23

Participant Flow

Participant milestones

Measure	Insertable Cardiac Monitor Implant Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
Overall Study STARTED	151
Overall Study COMPLETED	145
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System

Baseline characteristics by cohort

Measure	Insertable Cardiac Monitor Implant n=151 Participants Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
Age, Continuous	56.6 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants
Sex: Female, Male Male	101 Participants n=5 Participants
Region of Enrollment Russian Federation	7 participants n=5 Participants
Region of Enrollment Netherlands	40 participants n=5 Participants
Region of Enrollment Austria	28 participants n=5 Participants
Region of Enrollment Belgium	10 participants n=5 Participants
Region of Enrollment United Kingdom	8 participants n=5 Participants
Region of Enrollment Slovakia	25 participants n=5 Participants
Region of Enrollment Australia	33 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: All 151 subjects received a CareLink monitor software update. Subjects contributed 4,511 follow-up days in their first 30 days.

To assess the percentage of successful automatic wireless transmissions from the system within the first 30 days of implant.

Outcome measures

Measure

Insertable Cardiac Monitor Implant n=4511 Automatic Transmissions Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.

Success of Wireless Transmissions

73.1 percentage of successful transmissions Interval 68.3 to 77.4

PRIMARY outcome

Timeframe: 30 days

Population: For each subject implanted with a Reveal LINQ device an R-wave amplitude measurement is collected at implant and 1 month follow-up.

To characterize the signal quality of the R-wave amplitude at implant and one month.

Outcome measures

Measure	Insertable Cardiac Monitor Implant n=151 Participants Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
R-wave Amplitude R-wave at implant (n=151)	543.5 μV Standard Deviation 294.8
R-wave Amplitude R-wave at one month follow-up (n=150)	599.4 μV Standard Deviation 314.2

PRIMARY outcome

Timeframe: 30 days

Population: For each subject implanted with a Reveal LINQ device an R-wave amplitude measurement is collected at implant and 1 month follow-up.

The proportion of R-wave amplitudes that are greater than or equal to 200 μV will be estimated at implant and one month.

Outcome measures

Measure	Insertable Cardiac Monitor Implant n=151 Participants Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
R-wave Amplitudes Greater Than or Equal to 200 μV Implant	97.3 Percentage of subjects
R-wave Amplitudes Greater Than or Equal to 200 μV 1 Month	96.6 Percentage of subjects

SECONDARY outcome

Timeframe: 4 months

To assess atrial fibrillation detection by the Reveal LINQ insertable cardiac monitor (ICM). True and false positives will be reported.

Outcome measures

Measure	Insertable Cardiac Monitor Implant n=5304 Episodes Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
Accuracy of Reveal LINQ Device Detected Atrial Fibrillation False positive	843 Episodes
Accuracy of Reveal LINQ Device Detected Atrial Fibrillation True positive	4461 Episodes

SECONDARY outcome

Timeframe: 12 months

To characterize the system-related and procedure-related adverse events.

Outcome measures

Measure	Insertable Cardiac Monitor Implant n=151 Participants Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
Safety Endpoint Procedure related	9 Number of events
Safety Endpoint System related	45 Number of events
Safety Endpoint Procedure related (Serious events)	1 Number of events
Safety Endpoint System related (Serious events)	1 Number of events

SECONDARY outcome

Timeframe: 48 hours

Population: A Holter recording was performed in all 150 patients (one patient exited before 1 month), of which 141 were suitable for analysis after excluding recordings with technical issues, such as loss of telemetry or inability to process the data.

To compare the Reveal LINQ atrial fibrillation detection accuracy with atrial fibrillation detection from Holter monitoring. The true positive rate (sensitivity), specificity, positive predictive value and negative predictive value will be estimated using Holter recordings as the gold standard. Sensitivity measures the proportion of positives that are correctly identified as such. Specificity measures the proportion of negatives that are correctly identified as such. The positive and negative predictive values are the proportion of positive and negative detected patients that are true positive and true negative, respectively. Accuracy measures the proportion of all patients that are correctly identified as negative or positive.

Outcome measures

Measure	Insertable Cardiac Monitor Implant n=141 Participants Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor Sensitivity	97.4 Percentage of patients
Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor Specificity	97.0 Percentage of patients
Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor Positive predictive value	92.5 Percentage of patients
Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor Negative predictive value	99.0 Percentage of patients
Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor Accuracy	97.1 Percentage of patients

SECONDARY outcome

Timeframe: Day of implant

Population: There have been 151 implant procedures in the study, and 151 physician implant surveys were collected. Of these 151 surveys, 149 answered the question "Overall, how would you rate the ease of entire implant procedure?".

To understand the implanting physicians' experience with the implant of the Reveal LINQ, and the accompanying implanter tools. Responses to survey questions will be characterized. Below we summarize the responses to survey question "Overall, how would you rate the ease of entire implant procedure?".

Outcome measures

Measure	Insertable Cardiac Monitor Implant n=149 Participants Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
Survey of the Implanting Physicians Very Easy, No Changes Needed	54.4 Percentage of surveys
Survey of the Implanting Physicians Easy, but Needs Small Improvement	38.9 Percentage of surveys
Survey of the Implanting Physicians Needs Some Improvement	5.4 Percentage of surveys
Survey of the Implanting Physicians Needs Significant Improvement	1.3 Percentage of surveys

SECONDARY outcome

Timeframe: 12 months

Population: There were 149 patient surveys from 150 1-month follow-up visits collected, 145 surveys from 147 6-month visits, and 143 surveys from 144 12-month visits. Thus, 437 surveys were collected from 441 follow-up visits. The question "Based on your experience to date, please rate your satisfaction with the Reveal LINQ device" was answered 434 times.

To understand the study subjects' experience with the Reveal LINQ, the patient assistant and the patient home monitor. Patient responses to survey questions will be characterized. Below we will summarize the responses to question "Based on your experience to date, please rate your satisfaction with the Reveal LINQ device" over 1 month, 6 month, and 12 month follow-up visit.

Outcome measures

Measure	Insertable Cardiac Monitor Implant n=434 Surveys Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
Survey of the Patient Experience Over Time Very satisfied	66.6 Percentage of surveys
Survey of the Patient Experience Over Time Satisified	30.2 Percentage of surveys
Survey of the Patient Experience Over Time Needs Some Improvement	2.8 Percentage of surveys
Survey of the Patient Experience Over Time Needs Significant Improvement	0.5 Percentage of surveys

Adverse Events

Insertable Cardiac Monitor Implant

Serious events: 31 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Measure	Insertable Cardiac Monitor Implant n=151 participants at risk The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
Cardiac disorders Atrial fibrillation	6.0% 9/151 • Number of events 9 • 12 months
Cardiac disorders Atrial flutter	2.0% 3/151 • Number of events 3 • 12 months
Cardiac disorders Ventricular tachycardia	2.0% 3/151 • Number of events 3 • 12 months
Cardiac disorders Atrial tachycardia	1.3% 2/151 • Number of events 2 • 12 months
Nervous system disorders Syncope	1.3% 2/151 • Number of events 2 • 12 months
Respiratory, thoracic and mediastinal disorders Lung disorder	0.66% 1/151 • Number of events 1 • 12 months
General disorders Implant site pain	0.66% 1/151 • Number of events 1 • 12 months
Infections and infestations Urinary tract infection	0.66% 1/151 • Number of events 1 • 12 months
Nervous system disorders Cerebral haemorrhage	0.66% 1/151 • Number of events 1 • 12 months
Injury, poisoning and procedural complications Ligament sprain	0.66% 1/151 • Number of events 1 • 12 months
Nervous system disorders Cerebrovascular accident	0.66% 1/151 • Number of events 1 • 12 months
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.66% 1/151 • Number of events 1 • 12 months
Cardiac disorders Sinus node dysfunction	0.66% 1/151 • Number of events 1 • 12 months
Infections and infestations Gastroenteritis	0.66% 1/151 • Number of events 1 • 12 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.66% 1/151 • Number of events 1 • 12 months
Cardiac disorders Sinus arrhythmia	0.66% 1/151 • Number of events 1 • 12 months
Renal and urinary disorders Haematuria	0.66% 1/151 • Number of events 1 • 12 months
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.66% 1/151 • Number of events 1 • 12 months
Infections and infestations Chronic tonsillitis	0.66% 1/151 • Number of events 1 • 12 months
Cardiac disorders Pericarditis	0.66% 1/151 • Number of events 1 • 12 months
Investigations Allergy test	0.66% 1/151 • Number of events 1 • 12 months
Vascular disorders Aortic dissection	0.66% 1/151 • Number of events 1 • 12 months
Cardiac disorders Palpitations	0.66% 1/151 • Number of events 1 • 12 months
Hepatobiliary disorders Cholelithiasis	0.66% 1/151 • Number of events 1 • 12 months
General disorders Non-cardiac chest pain	0.66% 1/151 • Number of events 1 • 12 months

Other adverse events

Measure

Insertable Cardiac Monitor Implant n=151 participants at risk The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.

General disorders Implant Site Pain

25.8% 39/151 • Number of events 40 • 12 months

Additional Information

CRHF Clinical Research

Medtronic, plc

Phone: 800-328-2518

Email: MedtronicCRMtrials@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60