Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
254 participants
OBSERVATIONAL
2020-01-30
2024-11-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Claudio Muratore
Role: STUDY_CHAIR
Medtronic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
ICMI: Instituto Cardiovascular de Mínima Invasión
Jalisco, Jalisco, Mexico
CITIC
Mexico City, Mexico City, Mexico
CECLIQ: Centro de Estudios Clínicos de Querétaro
Querétaro City, Querétaro, Mexico
Helimedica
Naucalpan, State of Mexico, Mexico
Centro Medico ABC Santa Fe
Mexico City, , Mexico
ISSSTE Hospital General Tacuba
Mexico City, , Mexico
Instituto Nacional de Cardiologia
Mexico City, , Mexico
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MDT19012
Identifier Type: -
Identifier Source: org_study_id