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Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure (ALLEVIATE-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04452149
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : August 10, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Brief Summary:
The ALLEVIATE-HF study is a prospective, randomized, multi-site, interventional, investigational device exemption (IDE) study. The purpose of the study is to gain experience with utilization of an integrated device diagnostic-based risk stratification algorithm to guide patient care in subjects with NYHA class II and III heart failure.

Condition or disease Intervention/treatment Phase
Heart Failure NYHA Class II Heart Failure NYHA Class III Device: Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download Other: Medication intervention Not Applicable

Detailed Description:
The study will utilize the market released Reveal LINQ™ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download. The study will enroll up to 300 subjects at up to 30 sites in the US, and will characterize the safety of the patient management pathway. Subjects will be followed for a minimum of 7 months, and until study closure.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Following LINQ™ device insertion, subjects will be randomly allocated in a 2:1 ratio to either the observation arm or the intervention arm. Subjects in the observation arm will start with an observational period of 7 months and then transition to the intervention arm for the remainder of their participation in the study.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Observation Arm
Subjects will receive a Reveal LINQ™ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download, and will be managed per standard of care without visibility to the heart failure sensor data. Subjects will transition to the intervention arm after 7 months.
Device: Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download
Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download.

Experimental: Intervention Arm
Subjects will receive a Reveal LINQ™ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download, and will be managed using an integrated device diagnostic-based risk stratification algorithm combined with a clinical medication plan.
Device: Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download
Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download.

Other: Medication intervention
Risk status guided medication intervention.




Primary Outcome Measures :
  1. Safety of the patient management pathway (i.e. proportion of medication interventions with associated medication intervention related serious adverse events) [ Time Frame: Up to 3 years ]
    The proportion of medication interventions with one or more associated medication intervention related SAEs will be evaluated.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has NYHA Class II or III heart failure per most recent assessment, irrespective of left ventricular ejection fraction (LVEF)
  • Patient has documented recent history of symptomatic heart failure, defined as meeting any one of the following three criteria: 1. Hospital admission with primary diagnosis of HF within the last 12 months, OR 2. Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration within the last 6 months, OR 3. Patient had the following BNP/NT-proBNP6 within the last 3 months: If LVEF ≥ 50%, then BNP> 150 pg/ml or NT-proBNP > 450 pg/ml OR If LVEF is <50%, then BNP> 300 pg/ml or NT-proBNP > 900 pg/ml
  • Patient is willing and able to comply with the protocol, including LINQ ICM insertion, CareLink transmissions (including adequate connectivity), study visits and remote care directions.
  • Patient is 18 years of age or older.
  • Patient has a life expectancy of 12 months or more.

Exclusion Criteria:

  • Patient is currently implanted with a cardiovascular implantable electronic device (CIED) (e.g. ICM6, pacemaker, ICD, CRT-D or CRT-P device) or hemodynamic monitor.
  • Patient is receiving temporary or permanent mechanical circulatory support.
  • Patient had MI or PCI/CABG within past 90 days.
  • Patient has had a heart transplant, or is currently on heart transplant list.
  • Patient has severe valve stenosis on echocardiogram.
  • Patient has primary pulmonary hypertension (pre-capillary, WHO group 1,3,4,5).
  • Patient is on chronic intravenous inotropic drug therapy (e.g. dobutamine, milrinone).
  • Patient has severe renal impairment (eGFR <30 mL/min).
  • Patient has systolic blood pressure of < 90 mmHg at the time of enrollment.
  • Patient is on chronic renal dialysis.
  • Patient is unable to undergo one round of PRN medication intervention (i.e. 4 days of increased diuretics dose).
  • Patient has liver disease, defined as AST/ALT >5x normal, or bilirubin >2x normal.
  • Patient has serum albumin < 3 g/dL.
  • Patient has hypertrophic obstructive cardiomyopathy, constrictive pericarditis or amyloidosis.
  • Patient has complex adult congenital heart disease.
  • Patient has active cancer involving chemotherapy and/or radiation therapy.
  • Patient weighs more than 500 pounds.
  • 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 interventional study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452149


Contacts
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Contact: Aimee Laechelt (+1-763) 526-2730 aimee.a.laechelt@medtronic.com

Locations
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Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT04452149    
Other Study ID Numbers: ALLEVIATE-HF
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: August 10, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Heart Failure
Insertable Cardiac Monitor
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases