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 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT06409533
Eligibility Criteria:
Inclusion Criteria:
* Participants with atrial fibrillation and moderate-to-severe rheumatic mitral stenosis, as confirmed by ECG and echocardiography and diagnosed by the attending cardiologist.
* Patients with atrial fibrillation and severe rheumatic mitral stenosis who are ineligible for surgical intervention.
* Mean resting heart rate \> 80 bpm, with or without the use of rate control medication.
* Age range between 18 and 80 years.
* Provision of informed consent by participants.
Exclusion Criteria:
* Patients with paroxysmal atrial fibrillation.
* Heart failure (HF) with unstable hemodynamics.
* HF classified as NYHA (New York Heart Association) class IV.
* Patients currently undergoing treatment for hyperthyroidism who have been euthyroid for \< 3 months.
* Individuals diagnosed with a stroke, either ischemic or hemorrhagic.
* Symptomatic bradycardia accompanied by AV (atrioventricular) conduction disturbances.
* Use of a pacemaker, implantable cardioverter-defibrillator (ICD), or undergoing cardiac resynchronization therapy (CRT).
* Diagnosis of malignancy or obstructive sleep apnea (OSA).
* Patients with congenital heart defects.
* Atrial fibrillation secondary to electrolyte disturbances, hyperthyroidism, or reversible/non-cardiac causes.
* Inability to perform daily physical activities.
* Patients who have undergone CABG (coronary artery bypass graft), cardiac surgery, or a heart transplant within the past three months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06409533
Study Brief:
Protocol Section:
NCT06409533