LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.

Sponsor

Boston Scientific Corporation (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04790344

Collaborator

(none)

415

Enrollment

Locations

Arm

54.4

Anticipated Duration (Months)

6.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to collect sensor data from insertable cardiac monitor systems.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: Investigational LUX-Dx ICM Implant	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

415 participants

Allocation:

N/A

Intervention 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.

Primary Purpose:

Diagnostic

Official Title:

LUX-Dx Heart Failure Sensors in an Insertable Cardiac Monitor System Clinical Study (LUX-Dx TRENDS)

Actual Study Start Date :

Mar 20, 2021

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Arm All study subjects belong to Treatment Arm, which is receiving investigational LUX-Dx ICM device.	Device: Investigational LUX-Dx ICM Implant All subject will receive an investigational version of the LUX-Dx ICM device.

Arm

Intervention/Treatment

Experimental: Treatment Arm

All study subjects belong to Treatment Arm, which is receiving investigational LUX-Dx ICM device.

Device: Investigational LUX-Dx ICM Implant

All subject will receive an investigational version of the LUX-Dx ICM device.

Outcome Measures

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. [Through study completion of approximately 4.5 year]
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.).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grandview Medical Center - Affinity Hospital, LLC	Birmingham	Alabama	United States	35243
2	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
3	Mobile Infirmary	Mobile	Alabama	United States	36608
4	Arrhythmia Research Group	Jonesboro	Arkansas	United States	72401
5	Scripps Memorial Hospital	La Jolla	California	United States	92037
6	VA Loma Linda	Loma Linda	California	United States	92357
7	University of Southern California Hospital	Los Angeles	California	United States	90033
8	University of California - Irvine	Orange	California	United States	92868
9	San Diego Cardiac Center	San Diego	California	United States	92123
10	Holy Cross	Fort Lauderdale	Florida	United States	33308
11	North Florida South Georgia VA	Gainesville	Florida	United States	32608
12	University of Florida Health - Jacksonville	Jacksonville	Florida	United States	32209
13	St. John's Center for Clinical Research (First Coast Heart and Vascular Center, PLLC)	Jacksonville	Florida	United States	32216
14	Peace River Cardiovascular Center	Port Charlotte	Florida	United States	33952
15	Sarasota Memorial Hospital	Sarasota	Florida	United States	34239
16	Tallahassee Research Institute	Tallahassee	Florida	United States	32308
17	Advent Health - Tampa	Tampa	Florida	United States	33613
18	University Hospital	Augusta	Georgia	United States	30901
19	Northside Hospital	Gainesville	Georgia	United States	30342
20	Northeast Georgia Heart Center, Inc.	Gainesville	Georgia	United States	30501
21	Coliseum Medical Center	Macon	Georgia	United States	31201
22	Queen's Medical Center	Honolulu	Hawaii	United States	96817
23	St. Luke's Idaho Cardiology Associates	Boise	Idaho	United States	83712
24	Northwestern University	Chicago	Illinois	United States	60611
25	The University of Chicago	Chicago	Illinois	United States	60637
26	Advocate Good Samaritan Hospital	Downers Grove	Illinois	United States	60515
27	Franciscan Physician Network-Indiana Heart Physicians	Indianapolis	Indiana	United States	46237
28	Community Heart and Vascular Hospital	Indianapolis	Indiana	United States	46250
29	University of Kansas Hospital	Kansas City	Kansas	United States	66160
30	Baptist Health Lexington	Lexington	Kentucky	United States	40503
31	Brigham and Women's	Boston	Massachusetts	United States	02115
32	Boston Medical Center	Boston	Massachusetts	United States	02118
33	Spectrum Health Hospital	Grand Rapids	Michigan	United States	49503
34	Minneapolis VA	Minneapolis	Minnesota	United States	55417
35	Cardiology Associates Research, LLC	Tupelo	Mississippi	United States	38801
36	Saint Luke's Hospital of Kansas City	Kansas City	Missouri	United States	64111
37	Saint Louis University Hospital	Saint Louis	Missouri	United States	63110
38	Dartmouth Hitchock Medical Center	Lebanon	New Hampshire	United States	03766
39	Cardiovascular Associates of Delaware Valley	Sewell	New Jersey	United States	08080
40	Cardiovascular Associates of the Delaware Valley	Sewell	New Jersey	United States	08080
41	Capital Cardiology Associates, PC	Albany	New York	United States	12211
42	New York Methodist Hospital	Brooklyn	New York	United States	11215
43	New York Langone Health	New York	New York	United States	10016
44	Columbia University Medical Center/NYPH	New York	New York	United States	10032
45	The New York Hospital Medical Center of Queens	New York	New York	United States	11355
46	Medication Management	Greensboro	North Carolina	United States	27408
47	WakeMed	Raleigh	North Carolina	United States	27610
48	Wake Forest University School of Medicine	Winston-Salem	North Carolina	United States	27157
49	Sacred Heart Medical Center at Riverbend	Springfield	Oregon	United States	97477
50	Lehigh Valley Hospital	Allentown	Pennsylvania	United States	18103
51	Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033
52	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States	19107
53	University of Pittsburgh Medical Center Presbyterian Hospital	Pittsburgh	Pennsylvania	United States	15213
54	Ralph H. Johnson Department of Veterans Affairs Medical Center	Charleston	South Carolina	United States	29401
55	Prisma Health - Upstate	Greenville	South Carolina	United States	29605
56	Erlanger Medical Center	Chattanooga	Tennessee	United States	37403
57	St. Thomas Research Institute	Nashville	Tennessee	United States	37205
58	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
59	Cardiovascular Research of Knoxville	Powell	Tennessee	United States	37849
60	Orion Medical	Pasadena	Texas	United States	77505
61	PeaceHealth Southwest	Vancouver	Washington	United States	98664
62	Marshall Cardiology	Huntington	West Virginia	United States	25701
63	Mayo Clinic - La Crossee	La Crosse	Wisconsin	United States	54601

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

Principal Investigator: Scott Solomon, MD, Brigham and Women's Hospital
Principal Investigator: Elaine Wan, MD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Boston Scientific Corporation

ClinicalTrials.gov Identifier:

NCT04790344

Other Study ID Numbers:

C2118

First Posted:

Mar 10, 2021

Last Update Posted:

Jul 19, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Jul 19, 2022