N/A
Completed N=112
Reveal LINQ™ Heart Failure
Source: ClinicalTrials.gov NCT02758301 ↗Enrolled (actual)
112
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Number of Participants With Reveal Device Experiencing an Initial Acute Decompensated Heart Failure (ADHF) Event — 36 participants
Summary
The purpose of the LINQ™ HF study is to characterize Reveal LINQ™ derived data from patients with heart failure by assessing the relationship between changes in LINQ™ derived data and other physiologic parameters with subsequent acute decompensated heart failure (ADHF) events.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Reveal Device Experiencing an Initial Acute Decompensated Heart Failure (ADHF) Event |
36 | — |
| PRIMARY Number of Participants With a LINQ Device Experiencing a Second Acute Decompensated Heart Failure (ADHF) Events |
12 | — |
Eligibility Criteria
Inclusion Criteria
- Patient is 18 years of age or older
- Patient (or patient's legally authorized representative) is willing and able to provide written informed consent
- Patient is willing and able to comply with the protocol, including follow-up visits and CareLink transmissions
- Patient is NYHA Class III, per most recent assessment or at any time within 30 days prior to enrollment
- Patient had a HF event (HF event defined as meeting any one of the following three criteria):
- Admission with primary diagnosis of HF within the last 6 months, OR
- Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings within the last 6 months:
- Admission with secondary/tertiary diagnosis of HF
- Emergency Department
- Ambulance
- Observation Unit
- Urgent Care
- HF/Cardiology Clinic
- Patient's Home, OR
- Patient had the following BNP/NTpro-BNP within the last 3 months: If EF ≥ 50%, then BNP> 200 pg/ml or NTpro-BNP > 400 pg/ml OR If EF 400 pg/ml or NTpro-BNP > 800 pg/ml
Exclusion Criteria
- Patient is pregnant (all females of child-bearing potential must have a negative pregnancy test within 1 week of enrollment)
- Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager
- Patient has severe valvular heart disease as defined by hemodynamically significant valve stenosis and/or prosthetic heart valve
- Patient has existing IPG, ICD, CRT-D or CRT-P device
- Patient has severe renal impairment (eGFR <25mL/min)
Data sourced from ClinicalTrials.gov (NCT02758301). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.