Status:
UNKNOWN
LINQ for impEdance meAsuremeNt While Off From HF Medication Study
Lead Sponsor:
Medtronic BRC
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
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 visi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03245281
Start Date
October 30 2017
End Date
April 1 2019
Last Update
June 21 2018
Active Locations (1)
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1
Nhs Greater Glasgow & Clyde
Glasgow, United Kingdom, G12 0XH