~143 spots leftby Apr 2026

LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study

(LUX-Dx PERFORM Trial)

Recruiting in Palo Alto (17 mi)
+23 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Boston Scientific Corporation
No Placebo Group

Trial Summary

What is the purpose of this trial?

The LUX-Dx PERFORM Study had two primary objects which were (1) to characterize, in a general patient population, the utilization of the remote programming feature of the Boston Scientific (BSC) Insertable Cardiac Monitor (ICM) device and (2) to collect data to characterize the performance of arrhythmia detection algorithms. Data was also collected to characterize the ICM system related safety events.

Research Team

Eligibility Criteria

Inclusion Criteria

Patient is indicated to be implanted with the LUX-Dx ICM for one of the following reasons (grouped in three "Reason for Monitoring" subgroups): 1) Cryptogenic stroke, 2) Syncope, 3) AF management, Post-AF ablation, or Suspected AF
Patient is willing to enroll and be monitored in LATITUDE Clarity.
Patient is willing and able to be followed remotely via the ICM patient mobile app.
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Treatment Details

Interventions

  • Insertable Cardiac Monitor Remote Programming (Procedure)

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Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials
758
Recruited
867,000+
Michael F. Mahoney profile image

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein profile image

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology