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

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ClinicalTrials.gov Identifier: NCT04790344
Recruitment Status : Recruiting
First Posted : March 10, 2021
Last Update Posted : May 21, 2021
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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 Not Applicable

Detailed Description:
The primary objective of this study is to collect sensor data that will be used to develop and test 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 20, 2021
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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.




Primary Outcome Measures :
  1. Heart Failure Event Related Data will be assessed in all subjects through collection of reportable events and subsequent adjudication by the CEC. [ Time Frame: 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.).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04790344


Contacts
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Contact: Alysia Rosner 847-347-8129 alysia.rosner@bsci.com
Contact: Ming Duanmo 763-203-3428 ming.duanmo@bsci.com

Locations
Show Show 19 study locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Scott Solomon, MD Brigham and Women's Hospital
Principal Investigator: Elaine Wan, MD Columbia University
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT04790344    
Other Study ID Numbers: C2118
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases