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:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT04511520
Eligibility Criteria:
Inclusion Criteria:
* treated for atrial fibrillation with radiofrequency ablation
* cardiac disease
* providing written informed consent
Exclusion Criteria:
* Congenital and acquired heart defects.
* Acute coronary syndrome (unstable angina, myocardial infarction), myocardial revascularization during the previous 6 months
* Transient ischemic attack, stroke in history.
* Arterial hypertension (BP ≥160/100 мм. рт. ст.)
* The risk of thromboembolic complications on a scale CHA2DS2-VASc\> 2
* Risk of hemorrhagic complications of anticoagulant therapy (HAS-BLED\> 3 points on the scale).
* Complications after RFA.
* Chronic heart failure above III FC (NYHA), ejection fraction (EF) \<40%.
* Acute thrombophlebitis, complicated forms of varicose veins (thrombophlebitis, phlebothrombosis).
* Pronounced atherosclerosis of peripheral arteries (intermittent claudication), requiring surgical intervention.
* Violation of conductivity: AV-blockade 2-3 degrees, complete blockade of the bundle of the His bundle
* The presence of an implanted pacemaker pacemaker / pacemaker with a resynchronization function/cardioverter-defibrillator)
* Conduct RFA on AF earlier.
* The presence of a history of syncopal states.
* Diabetes mellitus type 1 and 2 in the stage of decompensation.
* Acute conditions: infection, exacerbation of chronic diseases in a period of less than 1 month prior to the study; severe injury, surgical interventions other than RFA for a period of less than 2 months from the start of the study
* Renal failure (creatinine levels above 300 µmol / L or 3.5 mg / dL).
* Patient's refusal to participate in the study
* Alcohol and drug abuse.
* Peptic ulcer and duodenal ulcer in history.
* Obesity, body mass index (BMI) ≥40 kg / m2
* Intake of Trimetazidine MB and its analogues for 3 months. before inclusion in research.
* The presence of any disease that, according to the doctor, prevents the inclusion of the patient in the study.
* unable to understand study instructions
* with considerable illness in the musculoskeletal system or with physical disability, which complicates exercise training
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
30 Years
Maximum Age:
70 Years
Study:
NCT04511520
Study Brief:
Protocol Section:
NCT04511520