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Multiple Cardiac Sensors for the Management of Heart Failure

NCT03237858 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-03-27

Study results available
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Summary

The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial intended to evaluate the clinical efficacy of the HeartLogic heart failure diagnostic feature.

Conditions

  • Heart Failure, Congestive

Interventions

DEVICE

HeartLogic ON

Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned OFF

DEVICE

HeartLogic OFF

Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned ON

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Adrian Hernandez, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-30
Primary Completion
2020-07-21
Completion
2020-07-21
FDA Device
Yes

Countries

  • United States
  • France
  • Germany

Study Locations

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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 NCT03237858 on ClinicalTrials.gov