LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.
Purpose
The primary objective of this study is to collect sensor data from insertable cardiac monitor systems.
Condition
- Heart Failure
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment Arm |
All study subjects belong to Treatment Arm, which is receiving investigational LUX-Dx ICM device. |
|
Recruiting Locations
University of Kansas Hospital
Kansas City, Kansas 66160
Kansas City, Kansas 66160
Contact:
Paola Roldan, MD
Paola Roldan, MD
More Details
- Status
- Recruiting
- Sponsor
- Boston Scientific Corporation
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.