PLASMA Mexico (PLASMA Mexico)

Medtronic

Status: Completed

Conditions: Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT04214899

MDT19012

Details and patient eligibility

About

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.

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.
• 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.

Enrollment: 254 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• 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