LEAN HF
Research type
Research Study
Full title
LINQ for impedance measurement while off from HF medication (LEAN HF) Study
IRAS ID
218655
Contact name
John Cleland
Contact email
Sponsor organisation
Medtronic Core Clinical Solutions
Duration of Study in the UK
1 years, 1 months, 0 days
Research summary
Research Summary
Heart failure (HF) is one of the commonest reasons for hospitalization among adults >65 years of age. Annually, >1 million patients are hospitalized with a primary diagnosis of heart failure, accounting for a total Medicare expenditure exceeding $17 billion.1
Despite progress in the management of HF, medication titration and adherence is a growing concern to clinicians, and other stakeholders (i.e., payers) because of mounting evidence that poor implementation of medication regimens is associated with a substantial increase in the risk of disease progression, adverse outcomes, hospitalization and higher costs.
Therefore, strategies to enhance adherence provide a potentially valuable strategy for improving survival, reducing hospitalization and managing patient symptoms in congestive HF.
In light of this the Medtronic Reveal LINQ ICM (Insertable Cardiac Monitor)will be implanted in patients to monitor the heart rhythm. For this study, the additional diagnostic capabilities related to heart failure will be added to the Reveal LINQ™ ICM by uploading a special software into the implantable device. Since the investigational software is not currently approved by the authorities for use in patients with Heart Failure, when it is uploaded into the Reveal LINQ™ ICM, the Reveal LINQ™ ICM is considered investigational for this study, untill disinstallation at study exit.
The purpose of this study is to understand if sensor information from the Reveal LINQ™ ICM collected with the additional diagnostic capabilities is sensitive enough to provide additional information on heart failure conditions and its worsening.Summary of Results
Twenty-six (26) subjects were enrolled under either Clinical Investigation Plan (CIP) v3.0 (24-APR-2017) or v5.0 (23-NOV-2017).
Descriptive statistics was used to summarize data of all eligible subjects (i.e., all patients with signed informed consent who met the inclusion/exclusion criteria) who were implanted.
Of the 26 subjects, 13 (54% female, 71 ± 7 years old, NYHA (New York Heart Association) II 77%) were implanted with the LINQ ICM (Implantable Cardiac Monitor), which required a suture in 7 (54%).
All subjects had the device correctly programmed and interrogated; however, only one subject had the investigational LINQ HF (Heart Failure) feature set correctly injected in their LINQ ICM, enabling the collection of sensor data under investigation.
Because Medtronic was not able to ensure the correct injection of the investigational LINQ HF feature set in the LINQ ICM, the study was put on hold from June 2018 until October 2019; as part of corrective and preventive actions, CIP was updated to v8.0 (21-AUG-2019) to include checks to confirm the correct injection of the LINQ HF feature set in the LINQ ICM, and a simplified study design.
After study resumption under CIP v8.0 (21-AUG-2019), 7 of the 13 implanted subjects were re-enrolled and re-started their study with a new baseline visit; three (3) of these subjects exited as screen failures because not eligible anymore.
Of the 13 implanted subjects, only 2 completed their follow-up period based on CIP v3.0/ v5.0, not re-consenting under CIP v8.0.
At study termination, the only 4 subjects remaining active (i.e., 7 re-consented subjects, minus 3 "new" screen failures) were exited with incomplete follow-up due to the COVID-19 pandemic.
Overall, 20 AEs were reported for 8 subjects (61.5%), all occurring after the LINQ ICM implant procedure. One (1) event was reported related to the LINQ ICM (7.7%), while 7 events were reported related to the HF condition of the subjects in 4 of them (30.8%). Two (2) events occurred during the drug regimen change period in 2 subjects (15.4%). Cardiac disorders were the most reported class of events, with 5 events being reported for 4 subjects (30.8%). Seriousness was reported for 16 events in 6 subjects (46.2%), all of them resulting in hospitalization. There were neither deaths nor device deficiencies reported throughout the duration of the LEAN HF study.
First because Medtronic was not able to ensure the correct injection of the investigational LINQ HF feature set in the LINQ ICMs, and later due to COVID-19 pandemic and Medtronic strategy changes for the LINQ HF software, in March 2022 the Sponsor decided to terminate the study.
As a consequence, the amount of data collected was not sufficient to evaluate the study objectives as defined in the study protocol.
All remaining active subjects at the time of the decision were contacted and informed by research team about study termination. They were exited from the study and followed-up per site’s standard of care, leaving the decision to have the device explanted to the subjects themselves: the battery of their LINQ ICM was depleted according to the normal battery life; hence, the investigational LINQ HF feature set was not working anymore and therefore, not a source of safety concern for these subjects.REC name
South East Scotland REC 01
REC reference
16/SS/0212
Date of REC Opinion
31 Jan 2017
REC opinion
Further Information Favourable Opinion