PRoMOTE Follow-up Observational Study

NCT ID: NCT03009175

Last Updated: 2025-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

287 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-08-31

Brief Summary

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The purpose of the study is:

* To evaluate the Heart Failure Risk Status (HFRS) feature performance.
* To establish the feasibility of remote follow-up in which patient risk triaging is performed by nurse-led review of HFRS feature as supplemental information.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Implantable Cardiac Defibrillator, Cardiac Resynchronization Therapy Defibrillator/Pacemaker

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Patients that meet all of following criteria could be included in the study:

* Implant of a commercially available Medtronic CRTD or ICD device with or without the Optivol Fluid Status Monitoring feature.
* Inclusion in the Medtronic Carelink Network.
* Local consent available for CL network as well as general local consent available for the use of data in observational studies signed and informative sheet delivered.

Exclusion Criteria

* Patients under the age of 18 years.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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PRoMOTE FU

Identifier Type: -

Identifier Source: org_study_id

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