Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT06896266
Eligibility Criteria:
Inclusion Criteria:
* Presence of atrial fibrillation or atrial flutter not self-limited.
* Performance of a cardiac imaging test with systolic function analysis (echocardiogram, magnetic resonance, CT scan) during the clinical course of the arrhythmia, exhibiting a left ventricular ejection fraction (LVEF) \<50%. In order for the test to be representative, the maximum time between the performance of the imaging test and the rhythm control procedure will be 3 months, in the absence of intervening cardiovascular events that may have caused a variation in LVEF. In the event that the patient had a previously known LVEF \<50%, the change with respect to this attributable to tachyarrhythmia has to be ≥10%.
* Signature of informed consent.
* Ability to understand and accept participation in the study.
Exclusion Criteria:
* Refusal of informed consent.
* Legal or juridical incapacity.
* Age \<18 years.
* Life expectancy less than 1 year.
* Impossibility of a follow-up of at least 6 months.
* Presence of a ventricular rate \>140 beats per minute, limiting the validity of imaging measurements.
* Presence of known factors causing systolic ventricular dysfunction:
* Prior cardiomyopathy diagnosis.
* Severe mitral or aortic valve disease.
* Non-revascularizable ischemic heart disease.
* Context of peri-resuscitation cardiopulmonary care.
* Abusive alcohol consumption, defined as \>80 grams of ethanol or \>7 standard alcoholic beverages per day.
* Active treatment with chemotherapeutic agents or radiation therapy to the thorax.
* Known infection with Trypanosoma cruzi, Borrellia burgdorferi or other infectious agent causing cardiomyopathy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06896266
Study Brief:
Protocol Section:
NCT06896266