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Cardiac Sensor

HeartLogic Diagnostic Feature for Heart Failure (MANAGE-HF Trial)

N/A

Waitlist Available

Led By Adrian Hernandez, 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

Current symptomatic heart failure or New York Heart Association Class II or III at the time of enrollment

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 12 months.

Awards & highlights

MANAGE-HF Trial Summary

This trial is testing a new heart failure diagnostic feature to see if it is effective.

Who is the study for?

This trial is for adults with symptomatic heart failure or NYHA Class II/III, implanted with specific defibrillators (CRT-D/ICD) that have HeartLogic. They should have had a recent worsening of heart failure or high levels of certain heart-related biomarkers. Excluded are those on regular IV heart therapy, pregnant women, participants in other studies without approval, and those with severe kidney issues or very short life expectancy.Check my eligibility

What is being tested?

The MANAGE-HF study tests the 'HeartLogic' diagnostic feature in patients' existing cardiac devices to see if it can effectively manage heart failure. Participants will be split into two groups: one where HeartLogic is turned on (active monitoring) and another where it's off (no active monitoring).See study design

What are the potential side effects?

Since this trial involves using an already-implanted device feature rather than a drug, traditional side effects aren't expected. However, there may be risks associated with increased medical attention or interventions due to the alerts from the device when HeartLogic is ON.

MANAGE-HF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I currently have heart problems that affect my daily activities.

MANAGE-HF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 12 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 months. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Manage-HF Phase I

Secondary outcome measures

Change in Medication Status

Change in NT-proBNP

Change in NYHA classification

+4 more

MANAGE-HF Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: HeartLogic ONActive Control1 Intervention

ICD and CRT-D devices with HeartLogic alerts turned ON

Group II: HeartLogic OFFPlacebo Group1 Intervention

ICD and CRT-D devices with HeartLogic alerts turned OFF

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor

719 Previous Clinical Trials

932,870 Total Patients Enrolled

Adrian Hernandez, MDPrincipal InvestigatorDuke University

16 Previous Clinical Trials

42,814 Total Patients Enrolled

Media Library

HeartLogic ON (Cardiac Sensor) Clinical Trial Eligibility Overview. Trial Name: NCT03237858 — N/A

Congestive Heart Failure Research Study Groups: HeartLogic ON, HeartLogic OFF

Congestive Heart Failure Clinical Trial 2023: HeartLogic ON Highlights & Side Effects. Trial Name: NCT03237858 — N/A

HeartLogic ON (Cardiac Sensor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03237858 — N/A

Congestive Heart Failure Patient Testimony for trial: Trial Name: NCT03237858 — N/A

Frequently Asked Questions

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

How many health care centers are administering this research trial within the city limits?

"There are a total of 27 medical sites that have been cleared to participate in this trial. These include, but are not limited to the University of Colorado in Aurora, Parkview Hospital, Inc. in Fort Wayne, and Community Health Network in Indianapolis."

Answered by AI

Are there any available vacancies in this medical trial?

"The clinicaltrials.gov website indicates that this trial is no longer seeking participants, having first been posted on August 30th 2017 and last modified the 13th of October 2022. Although 701 other research studies are actively recruiting subjects at present, this one has concluded its recruitment process."

Answered by AI

Who else is applying?

What state do they live in?

Indiana

What site did they apply to?

Emory University Hospital

Parkview Hospital, Inc.

What portion of applicants met pre-screening criteria?

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I have congestive heart failure and have been on medications for 3 yes now. I recently had a mitral valve clip that has made me worse. I'm only 53 and feel I have alot of life ahead of me and would like to improve my quality of life.

PatientReceived no prior treatments