PLASMA Chile (PLASMA Chile)

Medtronic

Status: Completed

Conditions: Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT04757142

MDT20035

Details and patient eligibility

About

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.

Full 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.

Enrollment: 246 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.