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

Primary Purpose

Heart Failure NYHA Class II, Heart Failure NYHA Class III

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download
Medication intervention
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure NYHA Class II focused on measuring Heart Failure, Insertable Cardiac Monitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cardiovascular Associates of MesaRecruiting
  • Arrhythmia Research GroupRecruiting
  • Saint Joseph Heritage Healthcare
  • Cardiology Associates Medical GroupRecruiting
  • Saint Joseph's Medical CenterRecruiting
  • South Denver Cardiology AssociatesRecruiting
  • FWD Clinical Research LLCRecruiting
  • Bay Area Cardiology Associates PARecruiting
  • Florida Heart CenterRecruiting
  • Baptist HealthRecruiting
  • First Coast Cardiovascular Institute PARecruiting
  • Citrus Cardiology Consultants PARecruiting
  • Baptist HospitalRecruiting
  • Northside HospitalRecruiting
  • Tallahassee Research InstituteRecruiting
  • Memorial Health University Medical CenterRecruiting
  • NorthShore University Health SystemRecruiting
  • Carle Foundation Hospital
  • Parkview HealthRecruiting
  • Ascension Medical Group - Saint VincentRecruiting
  • Iowa Heart Center
  • University of Kansas Medical CenterRecruiting
  • Saint Elizabeth HealthcareRecruiting
  • Baptist Healthcare SystemRecruiting
  • Norton HealthcareRecruiting
  • Advanced Cardiovascular Specialists
  • North Memorial Health Heart & Vascular CenterRecruiting
  • University of Mississippi Medical CenterRecruiting
  • Cardiology Associates of North MississippiRecruiting
  • Missouri Cardiovascular Specialists
  • CHI Health Nebraska Heart
  • CHI Health Creighton University Medical Center - Bergan MercyRecruiting
  • Lourdes Cardiology ServicesRecruiting
  • New Mexico Heart Institute PARecruiting
  • New York-Presbyterian Brooklyn Methodist HospitalRecruiting
  • Columbia University Irving Medical Center/NYPHRecruiting
  • Hudson Valley Heart CenterRecruiting
  • Saint Francis HospitalRecruiting
  • Stony Brook University HospitalRecruiting
  • Cone Health
  • Novant Health New Hanover Regional Medical CenterRecruiting
  • The Lindner Research CenterRecruiting
  • Mount Carmel EastRecruiting
  • OhioHealth Research and Innovation Institute (OHRI)Recruiting
  • Doylestown Health Cardiology a division of Doylestown Health PhysiciansRecruiting
  • Cardiology Consultants of PhiladelphiaRecruiting
  • Medical University of South CarolinaRecruiting
  • Prisma Health MidlandsRecruiting
  • The Stern Cardiovascular FoundationRecruiting
  • University of Tennessee Methodist PhysiciansRecruiting
  • Medical City Fort WorthRecruiting
  • Tyler Cardiovascular ConsultantsRecruiting
  • University of Virginia Medical Center
  • Sentara Norfolk General HospitalRecruiting
  • Swedish Medical Center Cherry HillRecruiting
  • Saint Joseph Medical Center (Tacoma WA)Recruiting
  • Charleston Area Medical Center (CAMC) Memorial HospitalRecruiting
  • West Virginia UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Observation Arm

Intervention Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 24, 2020
Last Updated
October 9, 2023
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT04452149
Brief Title
Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure
Acronym
ALLEVIATE-HF
Official Title
Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 3, 2020 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure NYHA Class II, Heart Failure NYHA Class III
Keywords
Heart Failure, Insertable Cardiac Monitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Observation Arm
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download
Intervention Description
Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download.
Intervention Type
Other
Intervention Name(s)
Medication intervention
Intervention Description
Risk status guided medication intervention.
Primary Outcome Measure Information:
Title
Safety of patient management pathway - Proportion of medication interventions with associated medication intervention related serious adverse events
Description
The proportion of medication interventions with one or more associated medication intervention related SAEs will be evaluated.
Time Frame
Up to 3 years
Title
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
Description
Treatment and Control groups will be compared using the Finkelstein-Schoenfeld method, including subjects with at least one "high" heart failure risk status.
Time Frame
Follow-up duration at endpoint analysis ranges from a minimum of 7 to a maximum of 13 months
Secondary Outcome Measure Information:
Title
Safety of Reveal LINQ™ system and procedure - Percentage of subjects experiencing system or procedure related serious adverse events
Description
Freedom from Reveal LINQ™ system and procedure related serious adverse events at 6 months will be evaluated.
Time Frame
Up to 6 months post Reveal LINQ™ device insertion attempt
Title
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
Description
Treatment and Control groups will be compared using the Finkelstein-Schoenfeld method, including subjects with at least one "high" heart failure risk status.
Time Frame
Follow-up duration at endpoint analysis ranges from a minimum of 7 to a maximum of 13 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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-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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aimee Laechelt
Phone
(+1-763) 526-2730
Email
aimee.a.laechelt@medtronic.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javed Butler, MD
Organizational Affiliation
Baylor Scott and White Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Associates of Mesa
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ambrose Panico, M.D.
Facility Name
Arrhythmia Research Group
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72410
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Devi Nair, M.D.
Facility Name
Saint Joseph Heritage Healthcare
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Individual Site Status
Terminated
Facility Name
Cardiology Associates Medical Group
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Dukes, M.D.
Facility Name
Saint Joseph's Medical Center
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cyrus Buhari, M.D.
Facility Name
South Denver Cardiology Associates
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ira Dauber, M.D.
Facility Name
FWD Clinical Research LLC
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Cammarata, M.D.
Facility Name
Bay Area Cardiology Associates PA
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Mester, M.D.
Facility Name
Florida Heart Center
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34950
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prasad Chalasani, M.D.
Facility Name
Baptist Health
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruple Galani, MD
Facility Name
First Coast Cardiovascular Institute PA
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sumant Lamba, M.D.
Facility Name
Citrus Cardiology Consultants PA
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hector Garcia, M.D.
Facility Name
Baptist Hospital
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sumit Verma, M.D.
Facility Name
Northside Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Sanchez, M.D.
Facility Name
Tallahassee Research Institute
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gian-Carlo Giove, M.D.
Facility Name
Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Newton, M.D.
Facility Name
NorthShore University Health System
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Metzl, M.D.
Facility Name
Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Terminated
Facility Name
Parkview Health
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Gregory, M.D.
Facility Name
Ascension Medical Group - Saint Vincent
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunit-Preet Chaudhry, M.D.
Facility Name
Iowa Heart Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Individual Site Status
Terminated
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madhu Reddy, M.D.
Facility Name
Saint Elizabeth Healthcare
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hareeprasad Vongooru, M.D.
Facility Name
Baptist Healthcare System
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Heatherly, M.D.
Facility Name
Norton Healthcare
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Srikanth Seethala, M.D.
Facility Name
Advanced Cardiovascular Specialists
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Individual Site Status
Withdrawn
Facility Name
North Memorial Health Heart & Vascular Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chike Obi, M.D.
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Craig Long, M.D.
Facility Name
Cardiology Associates of North Mississippi
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barry Bertolet, M.D.
Facility Name
Missouri Cardiovascular Specialists
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Individual Site Status
Withdrawn
Facility Name
CHI Health Nebraska Heart
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Individual Site Status
Withdrawn
Facility Name
CHI Health Creighton University Medical Center - Bergan Mercy
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Selma Mohammed, M.D.
Facility Name
Lourdes Cardiology Services
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darius Sholevar, M.D.
Facility Name
New Mexico Heart Institute PA
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eddie Brown, D.O.
Facility Name
New York-Presbyterian Brooklyn Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bharath Reddy, M.D.
Facility Name
Columbia University Irving Medical Center/NYPH
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Axsom, M.D.
Facility Name
Hudson Valley Heart Center
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Lyons, M.D.
Facility Name
Saint Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rita Jermyn, M.D.
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hal Skopicki, M.D.
Facility Name
Cone Health
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Individual Site Status
Suspended
Facility Name
Novant Health New Hanover Regional Medical Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Rommel, M.D.
Facility Name
The Lindner Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ankit Bhatia, M.D.
Facility Name
Mount Carmel East
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Gravelin, M.D.
Facility Name
OhioHealth Research and Innovation Institute (OHRI)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anup Basuray, M.D.
Facility Name
Doylestown Health Cardiology a division of Doylestown Health Physicians
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renee Sangrigoli, M.D.
Facility Name
Cardiology Consultants of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Goldstein, M.D.
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory Jackson, M.D.
Facility Name
Prisma Health Midlands
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
W. Robert Mazzei, M.D.
Facility Name
The Stern Cardiovascular Foundation
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank McGrew, M.D.
Facility Name
University of Tennessee Methodist Physicians
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isaac Rhea, M.D.
Facility Name
Medical City Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir Malik, M.D.
Facility Name
Tyler Cardiovascular Consultants
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raul Torres, M.D.
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Withdrawn
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erich Kiehl, M.D.
Facility Name
Swedish Medical Center Cherry Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Mignone, M.D.
Facility Name
Saint Joseph Medical Center (Tacoma WA)
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Zhang, M.D.
Facility Name
Charleston Area Medical Center (CAMC) Memorial Hospital
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elie Gharib, M.D.
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Sokos, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure

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