An observational study in Heart Failure, sponsored by Medtronic Cardiac Rhythm and Heart Failure. Completed at 7 sites in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by Medtronic Cardiac Rhythm and Heart Failure · Observational
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 254 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Medtronic Cardiac Rhythm and Heart Failure is the lead sponsor of 239 studies on the registry; 6 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Mexican patients diagnosed with Heart Failure with reduced ejection fraction, regardless of the time of disease progression.
Exclusion Criteria
Identify the main epidemiological and clinical characteristics of patients with Heart Failure with LVEF ≤ 45%, as well as the medical treatment models used.
Patient´s baseline characteristics, medical history, socio-economic data, ancillary studies, laboratory tests, and cardiovascular medication will be summarized using summary statistics. Continuous variables will be presented using mean, standard deviation (SD), minimum, median, maximum, and interquartile range (IQR). Categorical variables will be presented as frequency and percentage.
Time frame: 1 year
Determine the prescription rate of a cardiovascular pharmacological treatment and the indication and implant rate of a cardiac medical device in patients with Heart Failure with reduced ejection fraction.
Number and percentage of cardiovascular medication prescription by type Number and percentage of patients with an indication for a cardiac medical device Number and percentage of patients referred for an implant of a cardiac medical device Number and percentage of patients who received an implant of a cardiac medical device
Time frame: 1 year
Determine the mortality rate and its classification in patients with Heart Failure with LVEF ≤ 45%.
Number and percentage of deaths during the study follow-up period Number and percentage of deaths according to their classification Risk assessment of sudden cardiac death in the population Risks comparison of sudden death at 6 and 12 months of follow-up
Time frame: 1 year
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.
Number and percentage of reasons for not indicating a cardiac medical device Number and percentage of reasons for not implanting a cardiac medical device
Time frame: 1 year
Determine the population with a profile of 1.5 primary prevention of sudden cardiac death
Number and frequency of patients with indication for 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)
Time frame: 1 year
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.
Analysis will include Continuous variables will be summarized using mean, SD, minimum, median, maximum, and IQR. Categorical variables will be summarized as number and percentage of total patients. Analysis of health resources of the population at 6 and 12 months will be made using Student's t test if they have a normal distribution, or a Mann-Whitney U test in case of a non-normal distribution.
Time frame: 1 year
Plan to share: No
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Medtronic Cardiac Rhythm and Heart Failure