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Study terminated as sufficient data was collected to determine if impedance measurements with the LINQ™ device could track body fluid changes.
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The purpose of this study is to investigate the use of subcutaneous impedance measured with an implanted Medtronic Reveal LINQ™ insertable cardiac monitor for use as a fluid status monitor in hemodialysis patients. The study will measure the changes in subject subcutaneous impedance and compare with the fluid status assessed by the volume removed from the hemodialysis subject during dialysis sessions. Subcutaneous impedance trends will also be evaluated between dialysis sessions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic | Experimental | 'Reveal LINQ™ Insertable Cardiac Monitor' will be used to measure changes in subject subcutaneous impedance and compare with the fluid status assessed by the volume removed from the hemodialysis subject during dialysis sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reveal LINQ™ Insertable Cardiac Monitor | Device | Insertable cardiac monitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Fluid Volume Removed | The average fluid volume removal during the dialysis session over all patients. | 24 Days |
| Change in Subcutaneous Impedance | The change in impedance from the beginning to the end of a dialysis session, averaged over all patients and dialysis sessions | 24 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic | 'Reveal LINQ™ Insertable Cardiac Monitor' will be used to measure changes in subject subcutaneous impedance and compare with the fluid status assessed by the volume removed from the hemodialysis subject during dialysis sessions. Reveal LINQ™ Insertable Cardiac Monitor: Insertable cardiac monitor |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic | 'Reveal LINQ™ Insertable Cardiac Monitor' will be used to measure changes in subject subcutaneous impedance and compare with the fluid status assessed by the volume removed from the hemodialysis subject during dialysis sessions. Reveal LINQ™ Insertable Cardiac Monitor: Insertable cardiac monitor |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Average Fluid Volume Removed | The average fluid volume removal during the dialysis session over all patients. | Enrolled patients implanted with a LINQ device that had at least one dialysis session between 7 and 30 days post-implant. Formal statistical analysis was not performed because the likelihood from the pre-specified model did not converge due to small sample size. Average fluid loss is summarized instead. | Posted | Mean | Standard Deviation | mL | 24 Days |
|
Subjects were followed on average of 4.7 months with a range of 3 to 6 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 | Diagnostic | 'Reveal LINQ™ Insertable Cardiac Monitor' will be used to measure changes in subject subcutaneous impedance and compare with the fluid status assessed by the volume removed from the hemodialysis subject during dialysis sessions. Reveal LINQ™ Insertable Cardiac Monitor: Insertable cardiac monitor |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | Patient presented to the Alfred Hospital with headache, fever and photophobia. Following admission and assessment he was diagnosed with conjunctivitis and discharged on the 28th July. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site anaesthesia | Surgical and medical procedures | Pt has complained of mild numbness and very occasional discomfort at the implant site since 11.04.15. R/w by Dr Scott Wilson and nil signs of infection or cause for concern. Patient happy to continue. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Seamans, Principal Clinical Research Specialist | Medtronic | 7635262835 | jennifer.l.seamans@medtronic.com |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Change in Subcutaneous Impedance | The change in impedance from the beginning to the end of a dialysis session, averaged over all patients and dialysis sessions | Patients implanted with a LINQ having at least one dialysis session between 7 and 30 days post-implant | Posted | Mean | Standard Deviation | ohm | 24 days |
|
|
|
| 1 |
| 7 |
| 1 |
| 7 |
|
| Arteriovenous fistula | Renal and urinary disorders | Post dialysis on the 20.01.15, a thrombosed AVF was diagnosed post ultrasound and was admitted to the Alfred Hospital for a planned fistulagram and plasty. He then required an extra dialysis session. |
|
| Intestinal ischaemia | Gastrointestinal disorders | Patient presented to Emergency with worsening abdominal pain. A abdominal CT scan showed ischemic bowel and an evolving small bowel obstruction. The subject underwent a laparotomy and small bowel resection. |
|
|
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| 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 |