PLASMA Mexico (PLASMA Mexico)

  • STATUS
    Recruiting
  • End date
    Apr 20, 2022
  • participants needed
    250
  • sponsor
    Medtronic Cardiac Rhythm and Heart Failure
Updated on 13 February 2021
ejection fraction
heart failure

Summary

Collect data on Mexican 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, the use of resources associated with the follow-up of this group of patients and the barriers, if any, to receiving the indicated treatment.

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.
    • Determine the prescription rate of a cardiovascular pharmacological treatment and the prescription and implant rate of a cardiac medical device in patients with Heart Failure with reduced ejection fraction.
    • Determine the mortality rate and its classification in patients with Heart Failure with reduced ejection fraction.
    • Identify the barriers, if any, to prescribing and implanting a cardiac medical device in those patients with a Class I recommendation according to the ACC/AHA/HRS 2017 guidelines.
    • Determine the population with a profile of 1.5 primary prevention of sudden cardiac death (patients with Heart Failure in primary prevention who have one or more of the following risk factors: syncope or pre-syncope; left ventricular ejection fraction less than 25%; presence of non-sustained ventricular tachycardia; more than 10 ventricular extrasystoles per hour observed in a 24-hour Holter).
    • Collect data on the use of resources associated with the follow-up of patients diagnosed with Heart Failure with reduced ejection fraction during a period of 12 months to perform a secondary economic analysis.

Details
Condition Heart failure, Heart disease, Congestive Heart Failure, Cardiac Disease, cardiac failure, congestive heart disease
Clinical Study IdentifierNCT04214899
SponsorMedtronic Cardiac Rhythm and Heart Failure
Last Modified on13 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Heart disease or Cardiac Disease or Congestive Heart Failure or Heart failure?
Do you have any of these conditions: congestive heart disease or Heart disease or cardiac failure or Congestive Heart Failure or Cardiac Disease or Heart failure?
Do you have any of these conditions: Heart disease or cardiac failure or Heart failure or Congestive Heart Failure or Cardiac Disease or congestive heart disease?
Men and women 18 years
Patients with Heart Failure with LVEF 45% 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 LVEF > 45%
Patients unable of 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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