MedTrace Logo

OptiVol for Precision Medical Management of Heart Failure

NCT04206501 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-06-06

Study results available
· View outcomes & findings →

Summary

This clinical study is designed to show that a multidisciplinary team following a pre-specified standard of care medication decision model based on data from an implanted cardioverter device will increase the rate of change in Guideline Directed Medical Therapy (GDMT) in the intervention group compared to the conventional group in patients with ischemic and non-ischemic cardiomyopathies.

Conditions

  • Ischemic and Non-ischemic Cardiomyopathy

Interventions

DEVICE

Medtronic ICD with Opti Vol-Monitor

Physiologic and functional data from Cardiac Implantable Electronic Devices (CIEDs), including information on heart rate, activity, and fluid status derived from the OptiVol monitor, together with a concurrent patient engagement strategy through remote interactions, can be used to optimize the medical management of HF patients implanted with an ICD.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • University of Rochester

    lead OTHER

Principal Investigators

  • Spencer Z Rosero, MD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-05
Primary Completion
2022-11-01
Completion
2022-11-20
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04206501 on ClinicalTrials.gov