LINQ for impEdance meAsuremeNt While Off From HF Medication Study

• Status: Unknown status
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medtronic BRC
• Treatments: Diuretics

Criteria

Inclusion Criteria:

• Clinical Diagnosis of Heart Failure

• Plasma NT-proBNP (>250ng/L in SR and >1,000ng/L in AF)

• LVEF <50% measured in the year before enrolment

• Treated routinely with a daily dose of loop diuretic

• Receiving other guideline-indicated therapy for heart failure

• Willing to sign the informed consent form.

• Greater than 18 years of age.

Exclusion Criteria:

• Pregnant patients (all females of child-bearing potential must have a negative pregnancy test before LINQ ICM implant)

• eGFR <30 ml/minute.

• Any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study.

• Patients with implanted pacemakers or defibrillators

• Severe aortic or mitral valve disease

• Breathlessness at rest or on minor exertion.

• Chest pain at rest or on mild or moderate exertion.

• Patients deemed too unstable to miss 48 hours of heart failure treatment

• Enrolled in another study that could confound the results of this study, without documented pre-approval from Medtronic study manager