Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
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.

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Kansas Hospital
Kansas City, Kansas 66160
Contact:
Andrew Sauer, MD

More Details

Status
Recruiting
Sponsor
Boston Scientific Corporation

Study Contact

Alysia Rosner
847-347-8129
alysia.rosner@bsci.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.