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PLASMA Chile (PLASMA Chile)

NCT ID: NCT04757142

Last Updated: 2024-12-31

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

246 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-11

Study Completion Date

2024-11-12

Brief Summary

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Prospective, multicenter, observational cohort study to collect data on Chilean patients diagnosed with Heart Failure with reduced ejection fraction, their treatments, and their progress in a real-world environment. Additional objectives will be analyzed, such as mortality, and the barriers, if any, to receiving the indicated treatment.

Detailed Description

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Identify the main epidemiological and clinical characteristics of patients with Heart Failure with reduced ejection fraction, as well as the medical treatment models used.

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Men and women ≥18 years old.
* Patients with Heart Failure with Left Ventricular Ejection Fraction (LVEF) ≤ 40% will be included.
* Patients must be willing to comply with the study requirements and complete the Informed Consent Form (defined as the legally valid and documented confirmation of a patient's voluntary agreement to participate in the clinical study).

Exclusion Criteria

* Patients without Heart Failure or with Heart Failure with Left Ventricular Ejection Fraction (LVEF)\> 40%.
* Patients unable to comply with the Clinical Investigation Plan.
* Patients who are already enrolled or plan to participate in a concurrent clinical study of any medication and/or device at any time during the course of this clinical study without prior documented approval of the Medtronic Study Manager.
Minimum Eligible Age

18 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

Principal Investigators

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Claudio Muratore, MD

Role: STUDY_DIRECTOR

Medtronic

Locations

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Hospital Clínico Regional Guillermo Grant Benavente

Concepción, , Chile

Site Status

Hospital Clínico Pontificia Universidad Católica de Chile

Santiago, , Chile

Site Status

Hospital San Juan de Dios

Santiago, , Chile

Site Status

Hospital Talagante

Santiago, , Chile

Site Status

Hospital Hernan Henriquez Aravena

Temuco, , Chile

Site Status

Hospital Dr. Gustavo Fricke

Viña del Mar, , Chile

Site Status

Countries

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Chile

Other Identifiers

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MDT20035

Identifier Type: -

Identifier Source: org_study_id