Heart Failure / Investigational LUX-Dx ICM Implant · Interventional Study

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

ClinicalTrials.gov · September 3, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a completed registry record for LUX-Dx TRENDS, an interventional study of an investigational insertable cardiac monitor (ICM) system in 557 heart failure patients, with primary focus on collection and adjudication of sensor data for heart failure events over approximately 4.5 years. No outcome results or sensor performance findings are reported in this registry entry.

What was studied

Interventional, Single Group, Open label, Diagnostic purpose. Heart Failure; age from 18 Years. Intervention: Treatment Arm. n = 557. 57 sites: United States.

Key findings

Study enrollment completed with 557 actual participants Primary objective: collection of sensor data from LUX-Dx ICM and adjudication of heart failure events by clinical events committee Follow-up duration approximately 4.5 years

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a completed registry record of an interventional device study with no published results; outcomes and sensor performance data are not yet reported in this source.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Heart Failure Event Related Data will be assessed in all subjects through collection of reportable events and subsequent adjudication by the CEC. (assessed at Through study completion of approximately 4.5 year)

DesignInterventional, Single Group, Open label, Diagnostic purpose

PopulationHeart Failure; age from 18 Years

Sample size557

InterventionTreatment Arm

Setting57 sites: United States

Reported figures

Quoted from the source exactly as published.

Sample size557

Follow-up durationapproximately 4.5 year

Primary outcome measureHeart Failure Event Related Data assessed through reportable events and CEC adjudication

Caveats

This is a registry record only; no outcome results or sensor diagnostic performance data are reported
Primary outcome assessment method stated (CEC adjudication) but no efficacy or diagnostic accuracy findings are available
Study completion status does not confirm whether results have been analyzed or published elsewhere
No comparator group or control arm is mentioned

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Interventional device study with planned CEC adjudication; design stated but results not reported.

Directness

moderate

Heart failure patients receiving investigational ICM; directly relevant population and intervention.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Study design and conduct details insufficient; no results reported to appraise bias.

Sample adequacy

moderate

557 participants enrolled; adequate for exploratory sensor data collection study.

Source abstract

Registry record from ClinicalTrials.gov (NCT04790344). This is a study registration, not published results. Lead sponsor: Boston Scientific Corporation. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 557 participants (ACTUAL). Conditions: Heart Failure. Interventions: DEVICE: Investigational LUX-Dx ICM Implant. Primary outcome measures: Heart Failure Event Related Data will be assessed in all subjects through collection of reportable events and subsequent adjudication by the CEC. , Through study completion of approximately 4.5 year. Brief summary: The primary objective of this study is to collect sensor data from insertable cardiac monitor systems.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Boston ScientificHeart FailureInvestigational LUX-Dx ICM ImplantNCT04790344