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

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ClinicalTrials.gov Identifier: NCT04452149
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : June 2, 2022
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Tracking Information
First Submitted Date  ICMJE June 24, 2020
First Posted Date  ICMJE June 30, 2020
Last Update Posted Date June 2, 2022
Actual Study Start Date  ICMJE September 3, 2020
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2021)
  • Safety of patient management pathway - 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.
  • Efficacy of patient management pathway - Hierarchical composite of Cardiovascular death, HF events, change in Kansas City Cardiomyopathy Questionnaire and change in six-minute walk test distance [ Time Frame: Follow-up duration at endpoint analysis ranges from a minimum of 7 to a maximum of 13 months ]
    Treatment and Control groups will be compared using the Finkelstein-Schoenfeld method, including subjects with at least one "high" heart failure risk status.
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2020)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2021)
  • Safety of Reveal LINQ™ system and procedure - Percentage of subjects experiencing system or procedure related serious adverse events [ Time Frame: Up to 6 months post Reveal LINQ™ device insertion attempt ]
    Freedom from Reveal LINQ™ system and procedure related serious adverse events at 6 months will be evaluated.
  • Efficacy of patient management pathway - Hierarchical composite of Cardiovascular death, HF events, change in Kansas City Cardiomyopathy Questionnaire, change in six-minute walk test distance, and change in device-measured activity and night heart rate [ Time Frame: Follow-up duration at endpoint analysis ranges from a minimum of 7 to a maximum of 13 months ]
    Treatment and Control groups will be compared using the Finkelstein-Schoenfeld method, including subjects with at least one "high" heart failure risk status.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure
Official Title  ICMJE Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure
Brief Summary The ALLEVIATE-HF study is a prospective, randomized, controlled, blinded, multi-site, interventional, investigational device exemption (IDE) pivotal study. The purpose of the study is to demonstrate the safety and efficacy of a patient management pathway that utilizes an integrated device diagnostic-based risk stratification algorithm to guide patient care in subjects with NYHA class II and III heart failure, and to demonstrate the safety of the Reveal LINQ™ system and procedure in the study population.
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 700 subjects at up to 60 sites in the US. Subjects will be followed until the last enrolled subject is followed for 7 months or until the end of the study, whichever occurs first, or until time of study exit or death as applicable, but no longer than 36 months.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Following Reveal LINQ™ device insertion, subjects will be randomly allocated in a blinded fashion in a 1:1 ratio to either the observation arm or the intervention arm. Subjects in the observation arm will start with an observational period of 13 months and then transition to the intervention arm for the remainder of their participation in the study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Study site personnel and subjects will remain blinded to the subject's randomization assignment until the 13-month timepoint at which point the subjects will be in the intervention arm for the remainder of their participation regardless of original allocation, or until the time of investigator and/or subject contact in relation to a "high" risk status in an intervention arm subject.
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Failure NYHA Class II
  • Heart Failure NYHA Class III
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Placebo Comparator: 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 for heart failure management without visibility to the heart failure sensor data. Subjects will transition to the intervention arm after 13 months.
    Intervention: Device: 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.
    Interventions:
    • Device: Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download
    • Other: Medication intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 2, 2021)
700
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2020)
300
Estimated Study Completion Date  ICMJE March 2024
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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-proBNP 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. ICM, 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 or breastfeeding (all females of child-bearing potential must have a negative pregnancy test within 1 week of enrollment).
  • Patient is enrolled in another interventional study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Aimee Laechelt (+1-763) 526-2730 aimee.a.laechelt@medtronic.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04452149
Other Study ID Numbers  ICMJE ALLEVIATE-HF
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Medtronic Cardiac Rhythm and Heart Failure
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Medtronic Cardiac Rhythm and Heart Failure
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Javed Butler, MD University of Mississippi Medical Center
PRS Account Medtronic Cardiac Rhythm and Heart Failure
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP