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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

OutcomeResultp-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)
View full record on ClinicalTrials.gov →

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.

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