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The purpose of the Reveal LINQ Usability Study is to assess the functionality of the Reveal LINQ insertable cardiac monitor and accompanying system in patients indicated for an insertable cardiac monitor
The Reveal LINQ Usability Study is a prospective, non-blinded, non-randomized, multi-center clinical trial. Subjects will transmit device data via manual interrogation on a weekly basis during the first month and will be evaluated in the office at 1-month post-implant, in addition to an automatic nightly wireless data transmission using the MyCareLink® home monitor. All subjects will be requested to wear an external Holter for 48 hours at approximately 4 weeks post-insertion. Follow-up visits will continue at 6 and 12 months post-implant, with monthly manual interrogations. Subjects will be exited at their 12 month follow-up visit. The overall study will be conducted in 2 phases which differ primarily on inclusion criteria: Phase I subjects (initial 30 subjects) will have any indication for an ICM, Phase II subjects (all subjects following the initial 30 subjects) will be atrial fibrillation (AF) pre-ablation patients. The study will assess functionality of the Reveal LINQ device by assessing sensing performance and data transmission.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insertable Cardiac Monitor Implant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insertable Cardiac Monitor Implant | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Success of Wireless Transmissions | To assess the percentage of successful automatic wireless transmissions from the system within the first 30 days of implant. | 30 days |
| R-wave Amplitude | To characterize the signal quality of the R-wave amplitude at implant and one month. | 30 days |
| R-wave Amplitudes Greater Than or Equal to 200 μV | The proportion of R-wave amplitudes that are greater than or equal to 200 μV will be estimated at implant and one month. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Reveal LINQ Device Detected Atrial Fibrillation | To assess atrial fibrillation detection by the Reveal LINQ insertable cardiac monitor (ICM). True and false positives will be reported. | 4 months |
| Safety Endpoint |
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Inclusion Criteria:
Subject is willing to sign and date the consent form.
Subject is indicated for a Reveal device within the existing market approved indications
Phase I (initial 30 subjects): Any indication for a Reveal LINQ Device
Phase II (after the initial 30 subjects): Subject has atrial fibrillation and is indicated for and identified as an AF pre-ablation candidate*
*Note: Atrial fibrillation must be documented in the subject's medical history.
Subject has a life expectancy of 18 months or more.
Subject is willing and able to set up and utilize MyCareLink® home monitor and be remotely monitored (i.e., Medtronic CareLink® Network)
Subjects who are female of childbearing potential (last menses less than 1 year prior to enrolment) must:
have a negative pregnancy test at enrollment.
not be breastfeeding.
either be surgically sterile, postmenopausal (cessation of menses for at least 1 year), or agree to use a medically accepted, highly effective method of contraception during the entire duration of the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helmut Pürerfellner, MD | Allgemein öffentliches Krankenhaus der Elisabethinen Linz | Principal Investigator |
| Lukas Dekker, MD | Catharina Ziekenhuis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Prince Charles Hospital | Brisbane | Queensland | 4032 | Australia | ||
| Royal Adelaide Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36787645 | Derived | Saiz-Vivo J, Abdollahpur M, Mainardi LT, Corino VDA, De Melis M, Hatala R, Sandberg F. Heart rate characteristic based modelling of atrial fibrillatory rate using implanted cardiac monitor data. Physiol Meas. 2023 Mar 10;44(3). doi: 10.1088/1361-6579/acbc08. | |
| 25728756 | Derived | Purerfellner H, Sanders P, Pokushalov E, Di Bacco M, Bergemann T, Dekker LR; Reveal LINQ Usability Study Investigators. Miniaturized Reveal LINQ insertable cardiac monitoring system: First-in-human experience. Heart Rhythm. 2015 Jun;12(6):1113-9. doi: 10.1016/j.hrthm.2015.02.030. Epub 2015 Feb 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
To characterize the system-related and procedure-related adverse events.
| 12 months |
| Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor | 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. | 48 hours |
| Survey of the Implanting Physicians | 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?". | Day of implant |
| Survey of the Patient Experience Over Time | 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. | 12 months |
| Adelaide |
| South Australia |
| 5000 |
| Australia |
| Royal Melbourne Hospital | Melbourne | Victoria | 3050 | Australia |
| Allgemein öffentliches Krankenhaus der Elisabethinen Linz | Linz | Austria |
| Allgemeines Krankenhaus der Stadt Linz | Linz | Austria |
| UZ Leuven - Campus Gasthuisberg | Leuven | Belgium |
| CHU UCL Mont-Godinne - Dinant | Yvoir | Belgium |
| Catharina Ziekenhuis | Eindhoven | Netherlands |
| Academisch Ziekenhuis Maastricht | Maastricht | Netherlands |
| St. Antonius Ziekenhuis - Locatie Nieuwegein | Nieuwegein | Netherlands |
| Diakonessenhuis Locatie Utrecht | Utrecht | Netherlands |
| Isala Klinieken - Locatie Weezenlanden | Zwolle | Netherlands |
| Scientific Research Institute of Circulation's Pathology Agency on High Medical Technologies | Novosibirsk | Russia |
| Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH) | Bratislava | Slovakia |
| Eastbourne District General Hospital | Eastbourne | United Kingdom |
| James Cook University Hospital | Middlesbrough | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Success of Wireless Transmissions | To assess the percentage of successful automatic wireless transmissions from the system within the first 30 days of implant. | All 151 subjects received a CareLink monitor software update. Subjects contributed 4,511 follow-up days in their first 30 days. | Posted | Number | 95% Confidence Interval | percentage of successful transmissions | 30 days | Automatic Transmissions | Participants |
|
|
| |||||||||||||||||||||||||
| Primary | R-wave Amplitude | To characterize the signal quality of the R-wave amplitude at implant and one month. | For each subject implanted with a Reveal LINQ device an R-wave amplitude measurement is collected at implant and 1 month follow-up. | Posted | Mean | Standard Deviation | μV | 30 days |
|
| ||||||||||||||||||||||||||||
| Primary | R-wave Amplitudes Greater Than or Equal to 200 μV | The proportion of R-wave amplitudes that are greater than or equal to 200 μV will be estimated at implant and one month. | For each subject implanted with a Reveal LINQ device an R-wave amplitude measurement is collected at implant and 1 month follow-up. | Posted | Number | Percentage of subjects | 30 days |
|
| |||||||||||||||||||||||||||||
| Secondary | Accuracy of Reveal LINQ Device Detected Atrial Fibrillation | To assess atrial fibrillation detection by the Reveal LINQ insertable cardiac monitor (ICM). True and false positives will be reported. | Posted | Number | Episodes | 4 months | Episodes | Participants |
|
| ||||||||||||||||||||||||||||
| Secondary | Safety Endpoint | To characterize the system-related and procedure-related adverse events. | Posted | Number | Number of events | 12 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor | 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. | 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. | Posted | Number | Percentage of patients | 48 hours |
| ||||||||||||||||||||||||||||||
| Secondary | Survey of the Implanting Physicians | 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?". | 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?". | Posted | Number | Percentage of surveys | Day of implant |
|
| |||||||||||||||||||||||||||||
| Secondary | Survey of the Patient Experience Over Time | 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. | 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. | Posted | Number | Percentage of surveys | 12 months | Surveys | Participants |
|
|
12 months
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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 | 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. | 31 | 151 | 39 | 151 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 17 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 17 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 17 | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA 17 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 17 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 17 | Systematic Assessment |
| |
| Implant site pain | General disorders | MedDRA 17 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 17 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 17 | Systematic Assessment |
| |
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA 17 | Systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA 17 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17 | Systematic Assessment |
| |
| Sinus arrhythmia | Cardiac disorders | MedDRA 17 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 17 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17 | Systematic Assessment |
| |
| Chronic tonsillitis | Infections and infestations | MedDRA 17 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 17 | Systematic Assessment |
| |
| Allergy test | Investigations | MedDRA 17 | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA 17 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 17 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 17 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 17 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant Site Pain | General disorders | MedDRA 17 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CRHF Clinical Research | Medtronic, plc | 800-328-2518 | MedtronicCRMtrials@medtronic.com |
| ID | Term |
|---|---|
| D013575 | Syncope |
| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Belgium |
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| United Kingdom |
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| Slovakia |
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| Australia |
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