Trial Outcomes & Findings for Reveal LINQ™ Evaluation of Fluid (NCT NCT02275923)

Results Overview

The average fluid volume removal during the dialysis session over all patients.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

24 Days

Results posted on

2019-04-05

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	9
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reveal LINQ™ Evaluation of Fluid

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnostic n=7 Participants '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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	53.3 years STANDARD_DEVIATION 19.0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment Australia	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 Days

Population: 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.

The average fluid volume removal during the dialysis session over all patients.

Outcome measures

Outcome measures
Measure	Diagnostic n=6 Participants '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
Average Fluid Volume Removed	2948 mL Standard Deviation 683

PRIMARY outcome

Timeframe: 24 days

Population: Patients implanted with a LINQ having at least one dialysis session between 7 and 30 days post-implant

The change in impedance from the beginning to the end of a dialysis session, averaged over all patients and dialysis sessions

Outcome measures

Outcome measures
Measure	Diagnostic n=6 Participants '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
Change in Subcutaneous Impedance	207 ohm Standard Deviation 97

Adverse Events

Diagnostic

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Diagnostic n=7 participants at risk '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
Eye disorders Conjunctivitis	14.3% 1/7 • Number of events 1 • Subjects were followed on average of 4.7 months with a range of 3 to 6 months.
Renal and urinary disorders Arteriovenous fistula	14.3% 1/7 • Number of events 1 • Subjects were followed on average of 4.7 months with a range of 3 to 6 months.
Gastrointestinal disorders Intestinal ischaemia	14.3% 1/7 • Number of events 1 • Subjects were followed on average of 4.7 months with a range of 3 to 6 months.

Other adverse events

Other adverse events
Measure	Diagnostic n=7 participants at risk '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
Surgical and medical procedures Application site anaesthesia	14.3% 1/7 • Number of events 1 • Subjects were followed on average of 4.7 months with a range of 3 to 6 months.

Additional Information

Jennifer Seamans, Principal Clinical Research Specialist

Medtronic

Phone: 7635262835

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place