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NCT04757142Completed

PLASMA Chile (PLASMA Chile)

Source: ClinicalTrials.gov · Last updated 31 Dec 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
246 (actual)
First submitted
3 Feb 2021
Start date
11 Mar 2021
Primary completion date
26 Apr 2024
Lead sponsor
Medtronic Cardiac Rhythm and Heart Failure
NCT number
NCT04757142

What you commit to

  • Study type: Observational
  • Participants enrolled: 246
  • From 11 Mar 2021 to the primary completion date, 26 Apr 2024
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Lab values

  • Patients without Heart Failure or with Heart Failure with Left Ventricular Ejection Fraction (LVEF)\> 40%.

Other

  • Patients unable to comply with the Clinical Investigation Plan.

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Clínico Regional Guillermo Grant Benavente
Coordinator of this site? Confirm its status
ConcepciónChileUnknown status
Hospital Talagante
Coordinator of this site? Confirm its status
SantiagoChileUnknown status
Hospital San Juan de Dios
Coordinator of this site? Confirm its status
SantiagoChileUnknown status
Hospital Clínico Pontificia Universidad Católica de Chile
Coordinator of this site? Confirm its status
SantiagoChileUnknown status
Hospital Hernan Henriquez Aravena
Coordinator of this site? Confirm its status
TemucoChileUnknown status
Hospital Dr. Gustavo Fricke
Coordinator of this site? Confirm its status
Viña del MarChileUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.