Investigational LUX-Dx ICM Implant for Heart Failure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Heart Failure
Investigational LUX-Dx ICM Implant - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is designed to study the feasibility of collecting sensor data from insertable cardiac monitor systems.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Through study completion of approximately 4.5 year

Year 5
Heart Failure Event Related Data will be assessed in all subjects through collection of reportable events and subsequent adjudication by the CEC.

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Treatment Arm
1 of 1
Experimental Treatment

435 Total Participants · 1 Treatment Group

Primary Treatment: Investigational LUX-Dx ICM Implant · No Placebo Group · N/A

Treatment Arm
Device
Experimental Group · 1 Intervention: Investigational LUX-Dx ICM Implant · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion of approximately 4.5 year

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
672 Previous Clinical Trials
918,247 Total Patients Enrolled
70 Trials studying Heart Failure
43,669 Patients Enrolled for Heart Failure
Elaine Wan, MDPrincipal InvestigatorColumbia University
Scott Solomon, MDPrincipal InvestigatorBrigham and Women's Hospital
4 Previous Clinical Trials
19,440 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Patient is willing to be monitored in LATITUDE Clarity and use the ICM patient mobile app.
You are of legal age to give informed consent and are willing to participate in the trial.
One of the following echocardiography findings: LA width (diameter) >3.8 cm, LA length >5.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 26th, 2021

Last Reviewed: October 29th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.