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 @ 11:00 PM
Ignite Modification Date:
2025-12-24 @ 11:00 PM
NCT ID:
NCT03068169
Eligibility Criteria:
Patients after PVI
Inclusion Criteria:
* PVI in a patient with paroxysmal AF
* 18 - 70 years old
* Signed written informed consent Exclusion criteria
* BMI ≥35 kg/m2
* Chronic inflammatory disease, severe chronic kidney disease,
* Active cancer, and a period of 5 years from the end of treatment
* Use of antiarrhythmic agents after PVI
* Persistent AF
* Previous PVI
* The size of the chest that prevents wearing biomedical shirt
* Contraindications to wear biomedical shirt (structural disease of the chest, skin diseases, allergy for materials used in ECG shirts)
CRT recipients
Inclusion criteria:
* \> 18 years old
* Meeting the current European Society of Cardiology Guidelines indications for CRT implantation (including upgrades)
* Signed written informed consent Exclusion criteria
* Chest size which make impossible to wear nECG shirt
* Contraindications to wear biomedical shirt (structural disease of the chest, skin diseases, allergy for materials used in ECG shirts)
Patients during cardiac rehabilitation after myocardial infarction
Inclusion criteria:
* Patients within 3 months after myocardial infarction, after completed early post-infarction ambulatory cardiac rehabilitation
* Signed written informed consent
* 18 - 80 years old
Exclusion criteria:
* Dysfunction of the lower limbs or other walking impairments,
* Age below 18 or over 80 years old.
* Unstable angina pectoris.
* Life-threatening arrhythmias.
* Decompensated congestive heart failure.
* Left ventricular ejection fraction \<35%.
* Dissecting aneurysm of the aorta.
* Acute myocardial infarction.
* Vein thrombophlebitis.
* Pulmonary or peripheral embolism.
* Uncontrolled hypertension.
* Active inflammation.
* Other contraindication to physical activity.
* The state after the pacemaker or implantable cardioverter-defibrillator implantation (contraindication to bioelectrical impedance measurement).
* Persistent AF
* Previous PVI
Pediatric patients with SVT
Inclusion criteria:
* 5-18 years old
* Patients with diagnosed SVT qualified to EPS
* Signed written informed consent
Exclusion criteria:
* BMI ≥35 kg/m2
* Chronic inflammatory disease, severe chronic kidney disease,
* Active cancer, and a period of 5 years from the end of treatment
* The size of the chest that prevents wearing biomedical shirt
* Contraindications to wear biomedical shirt (structural disease of the chest, skin diseases, allergy for materials used in ECG shirts)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
100 Years
Study:
NCT03068169
Study Brief:
Protocol Section:
NCT03068169