Status:
COMPLETED
PLASMA Chile (PLASMA Chile)
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
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-wor...
Detailed Description
Identify the main epidemiological and clinical characteristics of patients with Heart Failure with reduced ejection fraction, as well as the medical treatment models used.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 11 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 12 2024
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT04757142
Start Date
March 11 2021
End Date
November 12 2024
Last Update
December 31 2024
Active Locations (6)
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1
Hospital Clínico Regional Guillermo Grant Benavente
Concepción, Chile
2
Hospital Clínico Pontificia Universidad Católica de Chile
Santiago, Chile
3
Hospital San Juan de Dios
Santiago, Chile
4
Hospital Talagante
Santiago, Chile