Heart Failure NYHA Class III Clinical Trial
— ALLEVIATE-HFOfficial title:
Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure
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.
Status | Recruiting |
Enrollment | 900 |
Est. completion date | April 2025 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | New Mexico Heart Institute PA | Albuquerque | New Mexico |
United States | FWD Clinical Research LLC | Boca Raton | Florida |
United States | Bay Area Cardiology Associates PA | Brandon | Florida |
United States | New York-Presbyterian Brooklyn Methodist Hospital | Brooklyn | New York |
United States | Charleston Area Medical Center (CAMC) Memorial Hospital | Charleston | West Virginia |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | University of Virginia Medical Center | Charlottesville | Virginia |
United States | The Lindner Research Center | Cincinnati | Ohio |
United States | Missouri Cardiovascular Specialists | Columbia | Missouri |
United States | Prisma Health Midlands | Columbia | South Carolina |
United States | Mount Carmel East | Columbus | Ohio |
United States | OhioHealth Research and Innovation Institute (OHRI) | Columbus | Ohio |
United States | Doylestown Health Cardiology a division of Doylestown Health Physicians | Doylestown | Pennsylvania |
United States | Saint Elizabeth Healthcare | Edgewood | Kentucky |
United States | NorthShore University Health System | Evanston | Illinois |
United States | Florida Heart Center | Fort Pierce | Florida |
United States | Parkview Health | Fort Wayne | Indiana |
United States | Medical City Fort Worth | Fort Worth | Texas |
United States | The Stern Cardiovascular Foundation | Germantown | Tennessee |
United States | Cone Health | Greensboro | North Carolina |
United States | Ascension Medical Group - Saint Vincent | Indianapolis | Indiana |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Baptist Health | Jacksonville | Florida |
United States | First Coast Cardiovascular Institute PA | Jacksonville | Florida |
United States | Arrhythmia Research Group | Jonesboro | Arkansas |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | Citrus Cardiology Consultants PA | Leesburg | Florida |
United States | CHI Health Nebraska Heart | Lincoln | Nebraska |
United States | South Denver Cardiology Associates | Littleton | Colorado |
United States | Baptist Healthcare System | Louisville | Kentucky |
United States | Norton Healthcare | Louisville | Kentucky |
United States | University of Tennessee Methodist Physicians | Memphis | Tennessee |
United States | Cardiovascular Associates of Mesa | Mesa | Arizona |
United States | Saint Joseph Heritage Healthcare | Mission Viejo | California |
United States | West Virginia University | Morgantown | West Virginia |
United States | Columbia University Irving Medical Center/NYPH | New York | New York |
United States | Sentara Norfolk General Hospital | Norfolk | Virginia |
United States | CHI Health Creighton University Medical Center - Bergan Mercy | Omaha | Nebraska |
United States | Cardiology Associates Medical Group | Oxnard | California |
United States | Baptist Hospital | Pensacola | Florida |
United States | Cardiology Consultants of Philadelphia | Philadelphia | Pennsylvania |
United States | Hudson Valley Heart Center | Poughkeepsie | New York |
United States | North Memorial Health Heart & Vascular Center | Robbinsdale | Minnesota |
United States | Saint Francis Hospital | Roslyn | New York |
United States | Northside Hospital | Saint Petersburg | Florida |
United States | Memorial Health University Medical Center | Savannah | Georgia |
United States | Swedish Medical Center Cherry Hill | Seattle | Washington |
United States | Advanced Cardiovascular Specialists | Shreveport | Louisiana |
United States | Saint Joseph's Medical Center | Stockton | California |
United States | Stony Brook University Hospital | Stony Brook | New York |
United States | Saint Joseph Medical Center (Tacoma WA) | Tacoma | Washington |
United States | Tallahassee Research Institute | Tallahassee | Florida |
United States | Cardiology Associates of North Mississippi | Tupelo | Mississippi |
United States | Tyler Cardiovascular Consultants | Tyler | Texas |
United States | Carle Foundation Hospital | Urbana | Illinois |
United States | Lourdes Cardiology Services | Voorhees | New Jersey |
United States | Iowa Heart Center | West Des Moines | Iowa |
United States | Novant Health New Hanover Regional Medical Center | Wilmington | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Medtronic Cardiac Rhythm and Heart Failure |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of patient management pathway - Proportion of medication interventions with associated medication intervention related serious adverse events | The proportion of medication interventions with one or more associated medication intervention related SAEs will be evaluated. | Up to 3 years | |
Primary | 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 | Treatment and Control groups will be compared using the Finkelstein-Schoenfeld method, including subjects with at least one "high" heart failure risk status. | Follow-up duration at endpoint analysis ranges from a minimum of 7 to a maximum of 13 months | |
Secondary | Safety of Reveal LINQ™ system and procedure - Percentage of subjects experiencing system or procedure related serious adverse events | Freedom from Reveal LINQ™ system and procedure related serious adverse events at 6 months will be evaluated. | Up to 6 months post Reveal LINQ™ device insertion attempt | |
Secondary | 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 | Treatment and Control groups will be compared using the Finkelstein-Schoenfeld method, including subjects with at least one "high" heart failure risk status. | Follow-up duration at endpoint analysis ranges from a minimum of 7 to a maximum of 13 months |
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