Lux Trends: LUX-Dx Heart Failure Sensors in an Insertable Cardiac Monitor System Clinical Study

  • STATUS
    Recruiting
  • sponsor
    Boston Scientific Corporation
Updated on 29 November 2022
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Summary

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.

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.

Details
Condition Heart Failure
Clinical Study IdentifierTX310272
SponsorBoston Scientific Corporation
Last Modified on29 November 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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