LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific… (NCT04790344) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.
United States525 participantsStarted 2021-03-20
Plain-language summary
The primary objective of this study is to collect sensor data from insertable cardiac monitor systems.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is labeled 'Active, Not Recruiting' — does that mean there's no chance I could still participate, or are there any circumstances where my doctor might still be able to get me enrolled?
2Since this study is focused on collecting data from an implantable cardiac monitor to track heart failure events, what would it actually mean for my day-to-day life to have this device implanted — how often would I need to come in for follow-up, and how long would I be monitored?
3This trial doesn't have a traditional phase label, which suggests it's more of a diagnostic or observational study rather than a treatment trial — does that mean I wouldn't be getting a new therapy, and how would participating or not participating affect my current heart failure treatment plan?
4The main thing being measured here is data around heart failure events, including hospitalizations or worsening symptoms — what kinds of heart failure events would the device be detecting, and what happens if the monitor picks something up during the study?
5If this trial is no longer enrolling, are there similar studies or approved implantable cardiac monitors already available that my doctor could discuss with me as an alternative way to better track my heart failure?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Heart Failure Event Related Data will be assessed in all subjects through collection of reportable events and subsequent adjudication by the CEC.
Timeframe: Through study completion of approximately 4.5 year