Back to resultsLUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.
Primary Purpose
Heart Failure
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Investigational LUX-Dx ICM Implant
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure
Eligibility Criteria
Key Inclusion Criteria:
- Patient is currently in NYHA Class II or III.
For patients with LVEF >40% measured on most recent available echocardiography within the previous 12 months:
- ONE (1) of the following echocardiography findings: LA width (diameter) >3.8 cm, LA length >5.0 cm, LA area >20 cm2, LA volume >55 ml, LA volume index >29 ml/m2, LVH defined by septal thickness or posterior wall thickness of >1.1 cm AND
- ONE (1) of the following: Elevated BNP/NT-proBNP as defined by: BNP >100 pg/ml or NT-proBNP >300 pg/ml within the previous 90 days for patients not in atrial fibrillation or BNP >300 pg/ml or NT-proBNP >900 pg/ml for patients in atrial fibrillation at the time of screening for eligibility OR Documented heart failure hospitalization or unscheduled heart failure IV therapy in the previous 12 months
For patients with LVEF <40% (for MI patients, measured no less than 30 days post-MI) on most recent available echocardiography within the previous 12 months:
- ONE (1) of the following: Elevated BNP/NT-proBNP as defined by BNP >150 pg/ml or NT-proBNP >600 pg/ml within the previous 90 days for patients not in atrial fibrillation or BNP >450 pg/ml or NT-proBNP >1800 pg/ml for patients in atrial fibrillation at the time of screening for eligibility OR Documented heart failure hospitalization or unscheduled heart failure IV therapy in the previous 12 months
- Patient is willing to be monitored in LATITUDE Clarity and use the ICM patient mobile app.
- Patient is of legal age to give informed consent and is willing to participate in the trial.
Key Exclusion Criteria:
- Patient is currently implanted with any other active electronic medical device.
- Patient has undergone a heart transplant.
- Patient is currently enrolled in another investigational study (excluding registries) without prior written approval from Boston Scientific.
- Patient is known to be pregnant at the time of enrollment or plans to become pregnant during study participation.
- Patient is diagnosed with amyloidosis or hypertrophic cardiomyopathy.
Sites / Locations
- Grandview Medical Center - Affinity Hospital, LLCRecruiting
- University of Alabama at Birmingham
- Mobile InfirmaryRecruiting
- Southwest Cardiovascular Associates
- Arrhythmia Research GroupRecruiting
- John Muir Medical CenterRecruiting
- Scripps Memorial HospitalRecruiting
- VA Loma LindaRecruiting
- Kaiser Permanenty Los Angeles Medical Center
- University of California - IrvineRecruiting
- San Diego Cardiac CenterRecruiting
- Cardiology Associates Medical GroupRecruiting
- Holy Cross
- The Cardiac and Vascular InstituteRecruiting
- North Florida South Georgia VARecruiting
- University of Florida Health - Jacksonville
- St. John's Center for Clinical Research (First Coast Heart and Vascular Center, PLLC)Recruiting
- Village Heart and Vein Center
- Naples Heart and Rhythm
- Orlando Regional Medical Center
- Peace River Cardiovascular Center
- Sarasota Memorial HospitalRecruiting
- University HospitalRecruiting
- Northside HospitalRecruiting
- Northeast Georgia Heart Center, Inc.Recruiting
- Coliseum Medical Center
- Queen's Medical CenterRecruiting
- St. Luke's Idaho Cardiology AssociatesRecruiting
- Northwestern UniversityRecruiting
- The University of Chicago
- Advocate Good Samaritan HospitalRecruiting
- Franciscan Physician Network-Indiana Heart PhysiciansRecruiting
- Community Heart and Vascular HospitalRecruiting
- University of Iowa Hospitals and Clinics
- University of Kansas HospitalRecruiting
- Baptist Health LexingtonRecruiting
- Baptist Health East Louisville
- Tulane University Heart and Vascular Institute
- Brigham and Women's Hospital
- Boston Medical Center
- M Health Fairview St. John's Hospital
- Minneapolis VARecruiting
- University of Mississippi Medical Center
- Cardiology Associates Research, LLC/North Mississippi Medical CenterRecruiting
- Saint Luke's Hospital of Kansas CityRecruiting
- Saint Louis University HospitalRecruiting
- Dartmouth Hitchock Medical Center
- New Jersey Medical School, University of Medicine & Dentistry of New Jersey
- Cardiovascular Associates of the Delaware ValleyRecruiting
- Capital Cardiology Associates, PCRecruiting
- New York Methodist HospitalRecruiting
- Columbia University Medical Center/NYPHRecruiting
- The New York Hospital Medical Center of QueensRecruiting
- Sanger Heart and Vascular Institute
- Medication ManagementRecruiting
- ECU Health Medical Center/Pitt County Memorial Hospital
- WakeMedRecruiting
- Wake Forest University School of MedicineRecruiting
- Sacred Heart Medical Center at RiverbendRecruiting
- Lehigh Valley HospitalRecruiting
- Penn State Health Milton S. Hershey Medical CenterRecruiting
- Thomas Jefferson University HospitalRecruiting
- University of Pittsburgh Medical Center Presbyterian HospitalRecruiting
- Wellspan York HospitalRecruiting
- Ralph H. Johnson Department of Veterans Affairs Medical CenterRecruiting
- Erlanger Medical Center
- St. Thomas Research InstituteRecruiting
- Vanderbilt University Medical CenterRecruiting
- Cardiovascular Research of KnoxvilleRecruiting
- University of Texas Medical BranchRecruiting
- Orion MedicalRecruiting
- Virginia Mason Medical Center
- VA Puget Sound Healthcare System
- Providence Sacred Heart Medical Center
- PeaceHealth SouthwestRecruiting
- Marshall CardiologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Arm
Arm Description
All study subjects belong to Treatment Arm, which is receiving investigational LUX-Dx ICM device.
Outcomes
Primary Outcome Measures
Heart Failure Event Related Data will be assessed in all subjects through collection of reportable events and subsequent adjudication by the CEC.
Heart Failure (HF) event is defined as:
HF Hospitalization: subject is admitted with a calendar date change with signs/symptoms of congestive heart failure (CHF) and receives unscheduled augmented HF therapy with oral or intravenous medications, ultrafiltration therapy or other parenteral therapy.
HF Outpatient Visit: subject has signs/symptoms of CHF, and receives unscheduled intravenous decongestive therapy in a setting that does not involve a hospitalization with a calendar date change (e.g.: ER visit, HF clinic, primary care clinic, etc.).
Secondary Outcome Measures
Full Information
NCT ID
NCT04790344
First Posted
March 4, 2021
Last Updated
October 9, 2023
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04790344
Brief Title
LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.
Official Title
LUX-Dx Heart Failure Sensors in an Insertable Cardiac Monitor System Clinical Study (LUX-Dx TRENDS)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2021 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is to collect sensor data from insertable cardiac monitor systems.
Detailed Description
The primary objective of this study is to collect physiological measurement data and heart failure (HF) event data that will be used to design and develop new diagnostic features for the insertable cardiac monitor (ICM) systems. This study will not have pre-defined statistical endpoints. To support the primary objective, diagnostic sensor data will be compared to reference clinical testing data and heart failure decompensation events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Physiologic Sensor data will be blinded to participants and care providers. LUX-Dx ICM commercial features will be Open Label.
Allocation
N/A
Enrollment
525 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
All study subjects belong to Treatment Arm, which is receiving investigational LUX-Dx ICM device.
Intervention Type
Device
Intervention Name(s)
Investigational LUX-Dx ICM Implant
Intervention Description
All subject will receive an investigational version of the LUX-Dx ICM device.
Primary Outcome Measure Information:
Title
Heart Failure Event Related Data will be assessed in all subjects through collection of reportable events and subsequent adjudication by the CEC.
Description
Heart Failure (HF) event is defined as:
HF Hospitalization: subject is admitted with a calendar date change with signs/symptoms of congestive heart failure (CHF) and receives unscheduled augmented HF therapy with oral or intravenous medications, ultrafiltration therapy or other parenteral therapy.
HF Outpatient Visit: subject has signs/symptoms of CHF, and receives unscheduled intravenous decongestive therapy in a setting that does not involve a hospitalization with a calendar date change (e.g.: ER visit, HF clinic, primary care clinic, etc.).
Time Frame
Through study completion of approximately 4.5 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Patient is currently in NYHA Class II or III.
For patients with LVEF >40% measured on most recent available echocardiography within the previous 12 months:
ONE (1) of the following echocardiography findings: LA width (diameter) >3.8 cm, LA length >5.0 cm, LA area >20 cm2, LA volume >55 ml, LA volume index >29 ml/m2, LVH defined by septal thickness or posterior wall thickness of >1.1 cm AND
ONE (1) of the following: Elevated BNP/NT-proBNP as defined by: BNP >100 pg/ml or NT-proBNP >300 pg/ml within the previous 90 days for patients not in atrial fibrillation or BNP >300 pg/ml or NT-proBNP >900 pg/ml for patients in atrial fibrillation at the time of screening for eligibility OR Documented heart failure hospitalization or unscheduled heart failure IV therapy in the previous 12 months
For patients with LVEF <40% (for MI patients, measured no less than 30 days post-MI) on most recent available echocardiography within the previous 12 months:
ONE (1) of the following: Elevated BNP/NT-proBNP as defined by BNP >150 pg/ml or NT-proBNP >600 pg/ml within the previous 90 days for patients not in atrial fibrillation or BNP >450 pg/ml or NT-proBNP >1800 pg/ml for patients in atrial fibrillation at the time of screening for eligibility OR Documented heart failure hospitalization or unscheduled heart failure IV therapy in the previous 12 months
Patient is willing to be monitored in LATITUDE Clarity and use the ICM patient mobile app.
Patient is of legal age to give informed consent and is willing to participate in the trial.
Key Exclusion Criteria:
Patient is currently implanted with any other active electronic medical device.
Patient has undergone a heart transplant.
Patient is currently enrolled in another investigational study (excluding registries) without prior written approval from Boston Scientific.
Patient is known to be pregnant at the time of enrollment or plans to become pregnant during study participation.
Patient is diagnosed with amyloidosis or hypertrophic cardiomyopathy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alysia Rosner
Phone
847-347-8129
Email
alysia.rosner@bsci.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Duanmu
Phone
763-203-3428
Email
ming.duanmu@bsci.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Solomon, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elaine Wan, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grandview Medical Center - Affinity Hospital, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vikram Arora, MD
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Withdrawn
Facility Name
Mobile Infirmary
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
E. Matthew Quin
Facility Name
Southwest Cardiovascular Associates
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85208
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Kaplan
Facility Name
Arrhythmia Research Group
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Devi Nair
Facility Name
John Muir Medical Center
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faizul Haque
Facility Name
Scripps Memorial Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajeev Mohan
Facility Name
VA Loma Linda
City
Loma Linda
State/Province
California
ZIP/Postal Code
92357
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jay Patel
Facility Name
Kaiser Permanenty Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nigel Gupta
Facility Name
University of California - Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dawn Lombardo
Facility Name
San Diego Cardiac Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hirsch Mehta
Facility Name
Cardiology Associates Medical Group
City
Ventura
State/Province
California
ZIP/Postal Code
55109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johnathan Duke
Facility Name
Holy Cross
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Individual Site Status
Withdrawn
Facility Name
The Cardiac and Vascular Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann Tong
Facility Name
North Florida South Georgia VA
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramil Goel
Facility Name
University of Florida Health - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Withdrawn
Facility Name
St. John's Center for Clinical Research (First Coast Heart and Vascular Center, PLLC)
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neil Sanghvi
Facility Name
Village Heart and Vein Center
City
Lady Lake
State/Province
Florida
ZIP/Postal Code
32159
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Jones
Facility Name
Naples Heart and Rhythm
City
Naples
State/Province
Florida
ZIP/Postal Code
34119
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Yin
Facility Name
Orlando Regional Medical Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shahid Qamar
Facility Name
Peace River Cardiovascular Center
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Individual Site Status
Withdrawn
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Betensky, MD
Facility Name
University Hospital
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darshak Karia
Facility Name
Northside Hospital
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alok Gambhir
Facility Name
Northeast Georgia Heart Center, Inc.
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ugochukwu Egolum
Facility Name
Coliseum Medical Center
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Hoffman
Facility Name
Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dipanjan Banerjee
Facility Name
St. Luke's Idaho Cardiology Associates
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melinda Marks
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ike Okwuosa, MD
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Withdrawn
Facility Name
Advocate Good Samaritan Hospital
City
Downers Grove
State/Province
Illinois
ZIP/Postal Code
60515
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Mao
Facility Name
Franciscan Physician Network-Indiana Heart Physicians
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atul Chugh
Facility Name
Community Heart and Vascular Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adigopula Sasikanth
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paari Dominic
Facility Name
University of Kansas Hospital
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
Paola Roldan, MD
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gery Tomassoni
Facility Name
Baptist Health East Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Parrott
Facility Name
Tulane University Heart and Vascular Institute
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nassir Marrouche
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerome Romero
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Monahan
Facility Name
M Health Fairview St. John's Hospital
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terrie-Ann Benjamin
Facility Name
Minneapolis VA
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Selcuk Adabag
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39219
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Hamilton
Facility Name
Cardiology Associates Research, LLC/North Mississippi Medical Center
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
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taiyeb Khumri, MD
Facility Name
Saint Louis University Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Mar
Facility Name
Dartmouth Hitchock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
Individual Site Status
Withdrawn
Facility Name
New Jersey Medical School, University of Medicine & Dentistry of New Jersey
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emad Aziz
Facility Name
Cardiovascular Associates of the Delaware Valley
City
Sewell
State/Province
New Jersey
ZIP/Postal Code
08080
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dilip Viswanath
Facility Name
Capital Cardiology Associates, PC
City
Albany
State/Province
New York
ZIP/Postal Code
12211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rizwan Alimohammad
Facility Name
New York 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
Facility Name
Columbia University 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
Elaine Wan, MD
Facility Name
The New York Hospital Medical Center of Queens
City
New York
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reema Bhatt
Facility Name
Sanger Heart and Vascular Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjiv Gulati
Facility Name
Medication Management
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jagadeesh Ganji
Facility Name
ECU Health Medical Center/Pitt County Memorial Hospital
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Withdrawn
Facility Name
WakeMed
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stuart Russell
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prashant Bhave, MD
Facility Name
Sacred Heart Medical Center at Riverbend
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Trojan, MD
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergio Cossu
Facility Name
Penn State Health Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Boehmer, MD
Facility Name
Thomas Jefferson University Hospital
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
Eduardo Rame, MD
Facility Name
University of Pittsburgh Medical Center Presbyterian Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany Palmer, MD
Facility Name
Wellspan York Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adnan Malik
Facility Name
Ralph H. Johnson Department of Veterans Affairs Medical Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Silverman
Facility Name
Erlanger Medical Center
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Individual Site Status
Withdrawn
Facility Name
St. Thomas Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Pickett
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JoAnn Lindenfeld, MD
Facility Name
Cardiovascular Research of Knoxville
City
Powell
State/Province
Tennessee
ZIP/Postal Code
37849
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Treasure
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhie Dean Sabayon
Facility Name
Orion Medical
City
Pasadena
State/Province
Texas
ZIP/Postal Code
77505
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karan Bhalla, MD
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bhanu Gupta
Facility Name
VA Puget Sound Healthcare System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie He
Facility Name
Providence Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Withdrawn
Facility Name
PeaceHealth Southwest
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Grant
Facility Name
Marshall Cardiology
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Rueda
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.
We'll reach out to this number within 24 hrs