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Diagnostic Sensor

ICM Implant for Heart Failure

N/A
Recruiting
Led By Scott Solomon, MD
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 specified echocardiography findings AND ONE (1) of the specified criteria for elevated BNP/NT-proBNP or documented heart failure hospitalization or unscheduled heart failure IV therapy in the previous 12 months.
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upthrough study completion of approximately 4.5 year
Awards & highlights
No Placebo-Only Group

Study Summary

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

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You have moderate to severe heart failure according to your doctor's assessment.
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If you had a heart ultrasound in the past year and it showed specific problems, or if a blood test showed certain heart-related markers, or if you were hospitalized for heart failure or needed unscheduled IV therapy for heart failure in the past year.
Select...
If you have a weak heart (LVEF <40%) or have had a heart attack, and your recent echocardiogram or heart tests show specific signs of heart failure, you may not be able to participate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion of approximately 4.5 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion of approximately 4.5 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
All study subjects belong to Treatment Arm, which is receiving investigational LUX-Dx ICM device.

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
699 Previous Clinical Trials
930,294 Total Patients Enrolled
71 Trials studying Heart Failure
45,070 Patients Enrolled for Heart Failure
Scott Solomon, MDPrincipal InvestigatorBrigham and Women's Hospital
5 Previous Clinical Trials
17,345 Total Patients Enrolled
Elaine Wan, MDPrincipal InvestigatorColumbia University

Media Library

Investigational LUX-Dx ICM Implant (Diagnostic Sensor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04790344 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what capacity is enrollment open for this medical experiment?

"To effectively execute the trial, 435 volunteers who satisfy the prerequisites will be required. These participants may come from a few different medical centres including Sacred Heart Medical Center at Riverbend in Springfield, Oregon and Cardiovascular Associates of the Delaware Valley in Sewell, New Jerseye Delaware Valley in Sewell, New Jersey."

Answered by AI

Are there any open seats in this clinical study?

"The details available on clinicaltrials.gov signify that the recruiting process for this medical experiment is ongoing. It was first posted in March 2021 and underwent its most recent update in November 2022."

Answered by AI

How many locations can individuals obtain this trial?

"67 medical institutions are currently recruiting for this trial, such as Sacred Heart Medical Center at Riverbend in Springfield, Cardiovascular Associates of the Delaware Valley in Sewell, and WakeMed in Raleigh. Additionally there are 64 other participating locations."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
WakeMed
Arrhythmia Research Group
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
3+
Recent research and studies
clinicaltrials.govStudy
LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.
2021. "LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04790344.
~241 spots leftby May 2026
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