Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure
Purpose
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.
Conditions
- Heart Failure NYHA Class II
- Heart Failure NYHA Class III
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- 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.
- Primary Purpose
- Treatment
- 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
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. |
|
Recruiting Locations
University of Kansas Medical Center
Kansas City, Kansas 66160
Kansas City, Kansas 66160
Contact:
Madhu Reddy, M.D.
Madhu Reddy, M.D.
More Details
- Status
- Recruiting
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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 900 subjects at up to 75 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.