Catheter Ablation in Atrial Fibrillation Patients With HFpEF (STABLE-SR IV Trial)

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Nov 5, 2023

Keywords

ClinConnect Summary

The STABLE-SR IV Trial is looking into the best treatment options for patients who have atrial fibrillation (a heart rhythm problem) and heart failure with preserved ejection fraction (HFpEF). Specifically, the study compares two treatments: radiofrequency catheter ablation (a procedure that helps correct the heart's rhythm) and antiarrhythmic drugs (medications that help control heart rhythm). The goal is to see which option leads to better long-term health outcomes for patients who are also receiving optimized heart failure medications.

To participate in this trial, individuals should be between the ages of 65 and 74 and have symptoms of paroxysmal or persistent atrial fibrillation. They should also have a specific heart function measurement and meet other criteria related to heart health. Participants will be asked to sign consent forms and may undergo additional evaluations to confirm their eligibility. If you or a loved one is considering joining this trial, it's a great opportunity to contribute to important research while potentially receiving advanced treatment for heart health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Symptomatic paroxysmal or persistent atrial fibrillation
• • CHADS2-VASc score≥ 2
• • Conform to the diagnosis of HFpEF
• • 1. NYHA II-IV level;
• • 2. Left ventricular ejection fraction (LVEF)≥ 50%;
• • 3. NT-proBNP≥ 300 pg/mL under sinus rhythm or NT-proBNP≥ 600 pg/mL under atrial fibrillation or flutter;
• • 4. Evidence of left ventricular diastolic dysfunction/raised left ventricular filling pressure on echocardiogram.
• • Sign informed consent
• Exclusion Criteria:
• • A life expectancy below 2 years due to any non-cardiovascular condition
• • Reversible atrial fibrillation, such as hyperthyroidism or hypokalemia-related atrial fibrillation
• • Prior atrial fibrillation ablation
• • Left atrial size≥ 55 mm
• • Heart failure due to any of the following: known genetic hypertrophic cardiomyopathy, infiltrative cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, constrictive pericarditis, active myocarditis, cardiac tamponade, or uncorrected primary valvular disease
• • Previous cardiac transplantation, complex congenital heart disease, rheumatic heart disease
• • Any contraindication for radiofrequency catheter ablation, antiarrhythmic drugs or anticoagulation
• • Acute coronary syndrome, cardiac surgery, angioplasty or cerebrovascular accident within 12 weeks before enrollment
• • Severe hepatic and renal dysfunction
• • Body mass index\> 50 kg/m2
• • Female in period of pregnancy or breast-feeding
• • Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study
• • Involved in other studies
• • The inclusion and exclusion criteria would be reassessed after run-in period and the cut-off of NT-proBNP would be set as \>125 pg/ml under sinus rhythm or \>365 pg/ml under AF/atrial flutter (AFL).