NCT03245281

LINQ for impEdance meAsuremeNt While Off From HF Medication Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Medtronic BRC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this non-randomized, cross-over, unblinded, single-center feasibility study is to assess the sensitivity of the LINQ ICM to measure derived-subcutaneous impedance in patients with heart failure during periods when diuretics and/or HF-medication consumption is increased or suspended for 48 hours (up to 72 hours at physician discretion) and to collect safety information related to HF status and to medication consumption changes.

Detailed description

Up to 30 subjects with a clinical diagnosis of Heart Failure will be enrolled in the study. It is expected that the subjects will be enrolled over a period of approximately 6 months. 3 follow up visits are planned at 2, 4 and 6 months (+/- one week) following the LINQ ICM implant. The total expected duration of the study is of about 1 year. According to the enrolment chronological order, each subject will be allocated to Diuretic Suspension group (DS), Diuretic Increase (DI) or Diuretic+MRA medication Suspension (DMS), which will define the medication regimen before the follow-up visit. Primary objective of the study is detecting the variation of impedance magnitude and the time of occurrence after medication regimen changes will be evaluated at each follow-up.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	Diuretic Suspension (DS)	Stop diuretic consumption in the 48h before the follow-up visit
DRUG	Diuretic Increase (DI)	Double diuretics dosage in the 48h before the follow-up visit
DRUG	Diuretic and Medication Suspension (DMS)	Stop diuretic and MRA medication consumption in the 48h before the follow-up visit

Timeline

• Start date: 2017-10-30
• Primary completion: 2019-01-01
• Completion: 2019-04-01
• First posted: 2017-08-10
• Last updated: 2018-06-21

Locations

1 site across 1 country: United Kingdom