Medtronic ICD with Opti Vol-Monitor for Cardiomyopathy ((OPTIMED-HF) Trial)

N/A

Waitlist Available

Led By Spencer Z Rosero, MD

Research Sponsored by University of Rochester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if using data from a special heart device can help doctors choose better medications for patients with certain heart conditions. The device provides real-time information about the patient's heart, guiding the medical team in their decisions.

Eligible Conditions

Cardiomyopathy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 month

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The of this study is the rate of change in medical management with beta-blockers, diuretics and sacubitril/Valsartan (defined as initiation, termination, switch, or dosing adjustment) in the intervention group compared to usual care

Secondary study objectives

All-cause mortality

Change in Laboratory Biomarkers (BNP-brain natriuretic peptide)

Healthcare utilization as determined by the number of unplanned office visits and hospitalizations in each group.

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ICM guided Medical Management GroupExperimental Treatment1 Intervention

A pre-specified management regimen based on standard clinical practice will be provided to the study team in which medical management including medication dosing (focusing on beta-blockers and diuretics) will be monitored and modified using Cardiac Implantable Electronic Devices (CIED) and OptiVol Monitor data. Based on CIED and patient engagement data, the study team will adjust medications and dosages, and optimize activity/exercise steps.

Group II: Conventional Management Control GroupActive Control1 Intervention

Non-study physicians will receive CIED/OptiVol data (as in usual care) and its use and the management strategy will be left to his/her discretion. To control for patient contact, patients in the conventional management group will have the same study visits as the interventional group and will include in-person device interrogation, and documentation of any medications changes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Medtronic ICD with Opti Vol-Monitor

2020

N/A

~10

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