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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT07153718
Eligibility Criteria:
Inclusion Criteria:
* All inclusion criteria must be met to be included in the study.
1. Age: Patients aged 18-80 years, with persistent atrial fibrillation (AF) and heart failure (HF), regardless of ejection fraction (EF).
2. Diagnosis of Heart Failure:
Heart Failure with Reduced Ejection Fraction (HFrEF): LVEF ≤ 40%. Heart Failure with Preserved Ejection Fraction (HFpEF): LVEF \> 40%, including HFmrEF (LVEF 41-50%).
3. Symptomatic Atrial Fibrillation: Patients with symptomatic persistent AF who have failed or are intolerant to at least one antiarrhythmic drug.
4. NYHA Class II-III: Patients with heart failure classified as NYHA class II-III, who are symptomatic despite optimal medical therapy. Informed Consent: Able to provide written informed consent for participation in the study.
5. Guideline-Recommended Pharmacologic Therapy: Patients who have received and are currently on guideline-recommended pharmacologic therapy for heart failure, including but not limited to ACE inhibitors, beta-blockers, diuretics, and mineralocorticoid receptor antagonists (MRAs).
Exclusion Criteria:
* Any of the following criteria shall be excluded.
1. End-Stage Heart Failure: Patients with heart failure classified as NYHA class IV or with LVEF ≤ 20%.
2. Severe Comorbidities:
3. Patients with severe pulmonary disease (e.g., COPD, severe restrictive lung disease).
4. Severe renal dysfunction (eGFR \< 30 mL/min/1.73m²) or advanced liver disease.
5. Active malignancy or other terminal illnesses with a prognosis of less than one year.
6. Inability to Tolerate Ablation:
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1. Patients unable to undergo catheter ablation due to anatomical or procedural issues.
2. Patients with contraindications to the procedure, including allergy to contrast agents or inability to tolerate anesthesia.
3. Left atrial thrombus confirmed by preoperative esophageal ultrasound; 7. Uncontrolled Arrhythmias: Patients with persistent or paroxysmal AF who are unable to maintain sinus rhythm despite optimal medical therapy or require frequent hospitalization for arrhythmia control.
8\. Pregnancy: Pregnant or breastfeeding women. 9. Contraindications to Anticoagulation: 10. Patients who are contraindicated for anticoagulation therapy (e.g., history of major bleeding or bleeding diathesis).
11\. History of Severe Valve Disease: Patients with a history of severe valve disease and/or prosthetic valve replacement.
12\. Recent Myocardial Infarction or Stroke: Patients who have had a myocardial infarction or stroke within the past 3 months.
13\. Contrast Agent Allergy: Patients with a known allergy to contrast agents. 14. Contraindications for Cardiac Catheterization: Any contraindications for cardiac catheterization, including inability to safely perform the procedure.
15\. Atrial Fibrillation Ablation: Patients who have previously undergone atrial fibrillation ablation.
16\. Cardiac Surgery: Patients who have undergone any cardiac surgery within the last 2 months.
17\. Life Expectancy: Patients with a life expectancy of less than 1 year.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07153718
Study Brief:
Protocol Section:
NCT07153718